Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 18, 2014 FBO #4438
DOCUMENT

65 -- 598-14-1-517-0007 Bed Monitoring System - Attachment

Notice Date

1/16/2014
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs; Oklahoma City VA Medical Center; 921 N.E. 13th Street; Oklahoma City OK 73104-5007
 

ZIP Code

73104-5007
 

Solicitation Number

VA25614R0188
 

Response Due

2/16/2014
 

Archive Date

3/18/2014
 

Point of Contact

La'Quise.Mack@va.gov
 

E-Mail Address

la'quise.mack@va.gov
(la'quise.mack@va.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

STATEMENT OF WORK - VISN 16 GRECC PMS A.BACKGROUND AND PURPOSE In this Statement of Work (SOW), the VA GRECC (Geriatric Research, Education and Clinical Center) provides a description of the performance and functional requirements of a proposed specialized patient monitoring system (GRECC Patient Monitoring System) that is capable of providing an accurate report of each hospital ward patient's time and position within a bed during any selected interval of time. The system shall employ advanced technological methods to wirelessly link the bed monitoring pads with a standalone computer that will collect, analyze and graphically display the data in a manner that is easily interpretable by clinicians. Offerors shall provide the required interfaces as specified in their submitted timelines and as further defined herein for a complete turnkey project. B.SCOPE OF WORK Vendor to develop, install, and debug a wireless bed patient monitoring system that has the following capabilities/working characteristics: B.1.Product Development: B.1.1.Patient Bed Monitoring Pads: These will be 30 inch X 60 inch pressure sensitive bed mattress overlays, each one of which has multiple pressure sensors laid out in a grid matrix that covers the area of the pad. As a minimum, there should be 100 pressure sensors laid out in a 5 X 20 grid matrix (as shown in Figures 1 and 2). The pads will need to be connected to an associated Sensor Electronics and Wireless Communications Box (SEWC Box) by a single flat cable. The cable needs to be long enough to allow the SEWC Box to be attached under the bed in such a way as to not limit the functionality (e.g., configuration change) of the bed. Each sensor within the pad should generate an electronic signal, the strength of which is proportional to the amount of pressure applied at that point on the grid. Thus, if a patient were to lie on the bed, the system should determine the relative proportion of the patient's weight that is applied over each sensor within the pad. Consequently, each of the sensors must have a pressure detection range that can allow for differentiation of the amount of a patient's weight that is applied to that part of the grid ranging from zero to >100 lbs. It may be necessary for the system to be able to adjust the gain from each sensor in order to ensure that the system can provide a clear indication of the pressure distribution across the pad. It would be desirable to have each bed monitoring pad designed in such a way that each sensor in the array can be replaced should it malfunction; in case of a failure of a particular sensor, only that sensor would have to be replaced thus reducing maintenance and replacement costs. Each pad must be capable of being cleaned and sterilized using commonly available hospital cleaners, chemical disinfectants, or sterilization systems. As the average length of hospitalization of the patients using these monitoring systems will be approximately 20 days, the pads must be capable of being cleaned and completely disinfected more than 20 times per year. They also need to be capable of being wiped clean with disinfectants every time the bed linens are changed. The pressure sensitive bed mattress pads also need to be designed to eventually be mass produced and they need to be very light weight, thin, durable, and require very low amp/voltage to operate. This could include some type matt with imprinted circuitry that includes an array of multiple Piezoelectric pressure sensors. If the long-term costs can be demonstrated to be equivalent or lower than using reusable pads, the development of disposable pressure monitoring pads could be considered as an alternative approach to addressing the needs of this contract. B.1.2.Sensor Electronics and Wireless Communications (SEWC) Box: This box will connect to the pad by a single cable and will be able to wirelessly transmit the continuous electronic signal from each pressure sensor to a PC monitoring station located up to 100 yards away. The vendor must construct the wireless network (based on the Institute of Electrical and Electronics Engineers' (IEEE) 802.15.4 standards) that will carry the wireless signal to the monitoring station. The cost of conducting the signal survey and creating the wireless network needs to be built into the contract. Depending on the requirements of the SEWC Box, it could be powered by batteries or through a connection to a standard 110 volt electrical outlet. Ideally, the system should be designed to allow for continuous monitoring even during power outages, by automatically switching from the standard 110 volt outlet to a battery. B.1.3.Base Monitoring Station (BMS): The Base Monitoring Station needs to connect wirelessly to multiple bed pressure pads (through the SEWC Boxes) and must have built-in software capable of interpreting the signals from each bed unit (as described below). The BMS needs to have the capacity to simultaneously connect to up to 20 different SEWC Boxes. B.1.4.System Software: Through its built-in software, the BMS needs to connect wirelessly to multiple bed pressure pads (through the SEWC Boxes) and be capable of interpreting the signals from each of these bed units, combining and analyzing the data across time, and displaying the results graphically and in tabular format (see Figure 3). The system should be capable of generating summary reports by bed (i.e., unit/SEWC Box #) to indicate the amount of time (e.g., percentage of time each shift, each 24 hour day, or each week) that a given patient is (a) sitting on the bed; (b) laying/posture on the bed; (c) off /out of the bed (i.e., only a 'no weight' signal is received); or, (d) disconnected from the system (i.e., no system signal detected meaning the system is off or malfunctioning). Similarly, the system should be capable of combining the data for all of the units (i.e., patients) so as to be able to generate summary reports indicating the average amount of time (mean + standard deviation) that all of the monitored patients spent in bed during the given intervals of time. As indicted (see sections B.1.2. and C.2.), upon delivery of the first prototype of the system, the system software needs to be capable of linking with and effectively analyzing the data stream from at least two SEWC boxes. However, the system has to be designed in such a way that the final complete system (to be developed as a separate contract) will be capable of linking with and effectively analyzing the data from at least 20 SEWC boxes. B.1.4.1.Clinical Output Reports: The end user needs to have the ability to generate output reports indicating the percentage of (monitored) time a given patient (as determined by SEWC Box #) spends lying in bed, sitting in bed, or out of bed each shift and each day. Similarly, it should be possible to generate a report indicating the averages for all units (beds, patients) combined. Access to these reports should be provided through a Clinical Output Report Menu. B.1.4.2.Administrative Output Report: The Administrative Output Report Menu should provide additional report options as well as the ability to download the raw data in a spreadsheet format for a selected SEWC Box or date range. B.1.4.3.System Access: Approved end users should be able to log onto the BMS in order to access the appropriate report menu. The system should be set up so that the GRECC Administrator is able to assign access rights to approved end users. The GRECC Administrator should also be able to determine which menu (clinical or administrative) a given end user can access. B.2.Expandability: The system should be designed in such a way as to allow it to be easily upgraded and expanded in the future to include more system capabilities. Potential future upgrades include: B.2.1.Inclusion of patient identifiers: As patients frequently move to different beds while in the hospital, the system should detect what patient is using a given bed at any point in time. This might be accomplished by having all patients wear special arm bracelets. Each bed monitoring pad could detect the arm bracelet to thus allow all data to be sorted by arm bracelet code rather than a given bed/ SEWC Box number. B.2.2.Monitoring in-bed movement: Future software upgrades to the system could analyze the pressure distribution when a patient is in the bed. The system could then alarm when there is constant pressure in one spot for more than a set period of time (e.g., one hour) indicating that a patient is not moving sufficiently to avoid pressure ulcers. B.2.3.More End-user Report Generating Capabilities: Future software upgrades could give end-users greater flexibility in generating reports. This might include the ability to choose different time intervals, patient characteristics, or other factors to sort the data or create subgroupings for analysis. B.2.4.Greater Error Checking Capabilities: Potential errors include: 1.) No signal detected either because the bed is not in use and the system is off, or due to system failure; and, 2.) No weight on mattress detected, which could be due to a) patient out of bed; b) no patient assigned to that bed and the system left on in error; or, c) system failure. B.3.Task Management B.3.1.Project Implementation Services: Vendor shall provide all services associated with the furnishing and installation of the proposed GRECC Patient Monitoring System (PMS), including, but not limited to System implementation, GRECC staff training, travel and expenses, software and software licenses and Technical Support services required for the system. Vendor shall provide the most efficient means of optimizing training, system maintenance, and data management. These services shall ensure that the system operates in an efficient manner as intended as defined above. The PMS shall allow for future expansion due to the anticipated and changing needs of the VISN 16 GRECC. B.3.2.Operations Timeline: The vendor will need to work closely with the GRECC clinical team in order to test and debug each prototype to ensure that the system is appropriately designed and that the software is optimally written to achieve program objectives. Vendor shall develop its management approach for accomplishing work defined in this proposal, which shall include a detailed timeline to complete the work as defined in this Statement of Work (SOW). The timeline shall include a breakdown of each specific task and the total time which will be required to furnish, install, test the system and train the GRECC VA staff at the NLR Division of the Central Arkansas Veterans Healthcare System (CAVHS) (i.e., Eugene J. Towbin Healthcare Center, 2200 Forts Root Drive, North Little Rock, Arkansas). The timeline shall indicate completion of all services within 360 calendar days after receipt of contract Award Notification and notice to proceed (See section C). C.DELIVERABLES SCHEDULE C.1.Acceptance of System Design Specifications: Any clarifications or requested modifications to the original submitted system design specifications should be completed within 30 days after receipt of notice to proceed. Once the updated and revised system design specifications and timelines are approved by the GRECC staff, work on development of the prototype GRECC PMS can be initiated (See sections A. and B.). C.2.Fully Functional Prototype: The vendor shall provide a fully functional prototype of the system within 210 days after receipt of notice to proceed. This would include at least two workable Bed Monitoring Pad and SEWC Boxes and the Base Monitoring System (BMS) with installed software. When the Bed Monitoring Pad and SEWC Box is properly placed on a hospital bed, the system should be able to accurately distinguish between whether an adult person (weight >70 lbs) is lying, sitting, or completely off of the monitored bed. The BMS should also be able to generate a report as to the amount of time that a person is lying, sitting, or completely off of the monitored bed. The system will also pass all safety inspections, meet applicable standards for reusable medical equipment, and receive approval from all applicable stakeholders for use in the clinical setting (See Section C.4.). C.3.Upgrades: After the first prototype is developed, the vendor will need to work with the GRECC staff at the CAVHS in order to ensure that the system is debugged and functions to the expectations set forth in this statement of work. Once the system is determined to be working correctly and passes all safety inspections, it will need to be installed in the clinical setting. After installation in the clinical setting, the system will need to undergo more extensive field testing. This testing will be conducted by the GRECC staff in cooperation with the manufacturer. Should problems be identified during the field testing, the manufacturer will work with the GRECC staff to make necessary hardware or software modifications to correct the problems. All testing and upgrades to the system should be complete within 360 calendar days after receipt of contract Award Notification and notice to proceed. C.4.Final Product Acceptance: As described below (see sections F.2. and F.3.), final acceptance of the product by the government will be made only after all stakeholders provide concurrence that all functional requirements from the Statement of Work have been incorporated into the product. As stated above (see section C.3.), all components of the system herein described shall be installed and operational within 360 calendar days after receipt of contract Award Notification and notice to proceed. D.APPLICABLE STANDARDS D.1.Wireless Communications: The wireless signal from the SEWC Box must be encrypted and otherwise compatible with all VHA regulations governing the use of wireless electronic monitoring devices with the clinical care areas. D.2.Security D.2.1.Information Security: The GRECC PMS system shall meet standards set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Privacy Act of 1974, Enterprise Architecture standards, and VA Cyber-Security requirements as applicable. Vendor shall adhere to all VA Requirements, policies and procedures with reference to security. D.2.2.Access Security: The system shall be capable of restricting individual-user access to the areas of the database to which they have been granted privileges including specific tables, fields and reports. Administrative functions for the system, such as security assignments, shall be made using an 'Administrative' GUI interface, not requiring programming capabilities. D.3.Data Ownership: The individual VA hospitals and VA Medical Centers will retain ownership of the data that they contribute to the database, as well as all derivative data, and analytic results. In order to maintain complete confidentiality, the Vendor shall adhere to all VA and Federal regulations regarding confidentiality. The Vendor shall not under any circumstances copy, print or distribute any data for which they are responsible for under this Contract to any party. The vendor shall strictly adhere to VA policies on confidentiality. D.4.Requirements for Data Management: The GRECC PMS must be capable of importing the pressure data from the bed pads as a continuous stream via a wireless linkage. The GRECC PMS will allow physicians, nursing staff, and other health care providers to track the amount of time that patients are in bed and if their time out of bed is adequate to meet their rehabilitation and recuperative care needs. D.4.1.Linking Data to Correct Patient: For this project, patient identifiers will not be entered into the GRECC PMS system. System reports summarizing the results for individual units will need to refer to the respective SEWC Box number for the unit. It will be up to the clinical staff to know on which bed each unit is located and to thus be able to associate a given SEWC Box number to a given patient. D.4.2.Data storage: It will be up to the system manufacturer to determine what raw data should be stored within the system. At a minimum, the system needs to store number of minutes per shift that there is a patient lying on the bed, sitting on the bed, or off of the bed (i.e., system is on but no weight detected on bed), or the SEWC Box is disconnected from the system (i.e., the unit is not on or functioning). The system manufacturer should also determine how GRECC System Administrator can archive or delete old data. A built-in daily data backup system should also be included. E.ACCEPTANCE CRITERIA E.1.System Test: Upon completion of the GRECC PMS software installation, the Vendor shall be responsible to support the government test of the entire system to ensure that it is operational and performs as intended. E.2.System Components E.2.1.Hardware and Software: Vendor shall furnish and install all software and/or systems and initial system hardware as defined herein. Non-proprietary workstation hardware necessary to operate the GRECC PMS will be identified and provided by the vendor. Nothing herein shall preclude the VHA from acquiring additional workstations from other sources as needed to allow for future expansion. Any authorized Department of Veterans Affairs employee or support service Vendor performing system upgrades or maintenance may concurrently use the system provided under this contract. E.2.2.Technical Support: Vendor shall provide all technical support, and any on-site and/or remote service required for 365 calendar days after receipt of contract Award Notification and notice to proceed. E.2.3.Authorization: The Vendor shall not perform any additional services beyond those authorized at any time during the duration of the contract without the expressed written approval of the CO in accordance with the terms and conditions of this Contract. Any additional work performed without this approval, will be performed by the Vendor at no additional cost to the government. F.CONTRACT LINE ITEM NUMBER (CLIN) Payments for this contract shall be made based on schedule of deliverables. Specific detailed requirements are provided in the following sections. F.1.CLIN Task 001 - Refinement of System Design Specifications F.1.1.Completion of System Design Modifications: After careful review by GRECC staff of vendor's system design specifications and discussion with vendor, clarifications or minor modifications to the specifications may be requested. It will be up to the vendor to update their system design specifications and timelines to address all concerns raised by the reviewers. F.1.2.Acceptance of System Design Specifications: Once the updated and revised system design specifications and timelines are approved by the GRECC staff, work on development of the prototype GRECC PMS can be initiated. F.2.CLIN Task 002 - Delivery of Prototype F.2.1.Hardware: The vendor shall install, implement, configure and test the system prototype at the CAVHS. The service under this task includes all labor, supplies, supervision, travel, per diem and customary charges required to complete the installation. F.2.2.Software: The vendor shall provide an unlimited, perpetual, non-exclusive, software site license for the VISN GRECC PMS software. F.2.3.Testing: Prior to use of the system with actual patients, concurrence will be obtained from all stakeholders through Acceptance Testing of the system to determine the product's operational readiness for deployment. Stakeholders will ensure that the basic functional requirements from this SOW have been incorporated into the product with the major focus of the review being patient safety and operational readiness for further live testing. F.2.4.Acceptance of Implementation Plan: Once Acceptance Testing is complete and all corrective actions completed to the satisfaction of all stakeholders, this phase of the system implementation will be complete. In the next phase of implementation, the system will be installed and tested in the clinical setting. F.3.CLIN Task 003 - Final Installation and Testing in Clinical Setting F.3.1.Hardware: The vendor shall work with the GRECC staff to install, implement, configure and test the system on the 3B GEM Unit at the North Little Rock Division of the CAVHS. This would include at least two fully functional Bed Monitoring Pads and SEWC Boxes. The Base Monitoring System (BMS) with installed software should be fully functional and capable of linking with at least 20 Bed Monitoring Pads and SEWC Boxes. The service under this task includes all labor, supplies, supervision, travel, per diem and customary charges required to complete the installation. F.3.2.Software: The software installed on the BMS The vendor shall provide an unlimited, perpetual, non-exclusive, software site license for the VISN GRECC PMS software. F.3.3.Testing: Prior to use of the system with actual patients, concurrence will be obtained from all stakeholders through Acceptance Testing of the system to determine the product's operational readiness for deployment. Stakeholders will ensure that the basic functional requirements from this SOW have been incorporated into the product with the major focus of the review being patient safety and operational readiness for further live testing. F.3.4.Acceptance of Implementation Plan: Once Acceptance Testing is complete and all corrective actions completed to the satisfaction of all stakeholders, this phase of the system implementation will be complete. In the next phase of implementation, the system will be installed and tested in the clinical setting. F.4.CLIN Task 004 - Training F.4.1.Onsite Training: Before the system is installed and tested in the clinical setting, the Vendor shall provide on-site training to both GRECC staff and other applicable non-clinical staff on the use and operations of the software and hardware. Final dates and times for all training shall be mutually agreed upon between the Vendor and with the GRECC POC at the CAVHS. Training shall include but not be limited to on-site orientation and training of Key personnel in operation and care of the system and software furnished, as well as an actual demonstration of the system. Vendor shall provide guidance on completing any adjustments or other actions that may be undertaken by operating personnel in the event of system failure, provided that such adjustment or action will in no way jeopardize the Government's rights under this contract. Training shall be provided in various forms of media such as, but not limited to, tutorials, manuals, Computer-based training, distance and on-site training, as appropriate. Technical training shall be provided. The GRECC PMS Vendor shall train Biomedical Engineering and other identified technical staff onsite about normal system maintenance and provide written documentation about maintenance recommendations and procedures. This training and documentation shall detail initial response to problem solving and must include information on triaging system components to efficiently determine nature of failure (eg. device interface, system hardware, application) as well as recommended corrective actions. F.4.2.Clinical Staff Training: The GRECC personnel will be responsible for training all clinical staff including the Nursing Staff. F.5.CLIN TASK 005 -Hardware F.5.1.Computer & Wireless Network Hardware: Vendor shall provide all computer and wireless network hardware as required to operate the system (per sections B.1.2 and B.1.3) including workstation computers, monitors, keyboards, mice, touch screens, mounting hardware, and so forth. Equipment must be non-proprietary to allow VISN 16 to acquire from other sources to accommodate future expansion. Vendor is responsible for the installation, testing, servicing, and upgrading of all proposed computer and wireless network hardware. The vendor shall provide an unlimited, perpetual, non-exclusive, software site license for the VISN GRECC PMS software (which is described in section B.1.4). F.5.2.Warrantee: A comprehensive service contract for all proposed hardware is required. All required service, maintenance and upgrades associated with that contract must be performed by the Vendor or the Vendor's agent. Pricing for computer and wireless network hardware support and service must be included. F.6.CLIN TASK 006 - Modifications, Maintenance, and Support Services F.6.1.System Warranty: The Vendor shall provide warranty, maintenance and support services 365 calendar days after receipt of contract Award Notification and notice to proceed and shall include all services further defined herein (System Specifications). The Vendor shall provide all maintenance, support services and any needed hardware or software updates to ensure that each component system continues to function as intended for at least 365 calendar days after receipt of contract Award Notification and notice to proceed. F.6.2.Software Lifespan: It is understood that the software will not contain any code (e.g., virus) that will disable the software, and if such code exists, the Vendor agrees to indemnify the government for all damages suffered as a result of such code. G.SYSTEM/ SERVICE REQUIREMENTS G.1.Product Modification, Removal or Recall: Vendor shall complete the following in the event of a defect in the product provided. G.1.1.Notification: If any product awarded under this solicitation requires modification, is removed or recalled by the Vendor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the Vendor or manufacturer will immediately notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification, which shall include, but not be limited to the following: G.1.1.1.Item Description: Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an award on this solicitation. G.1.1.2.Reason: Reasons for modifications, removal or recall. G.1.1.3.Instructions for Return: Necessary instructions for return for credit, replacement or corrective action. G.1.1.4.Corrective Action Plan: Provide written corrective action which will be taken by the Vendor if the above should occur within ten (10) calendar days of receipt of such notification. G.1.2.Who to Contact: Provide the above information to all agencies and VA Facilities who purchased the product. The Contracting Officer shall be provided a copy of the notification and a list of all agencies and/or VA facilities notified. G.1.3.Costs: Vendor shall be responsible for any costs associated with the above (including replacement of the system). G.2.System Access: In accordance with the Conformance Standards, the Vendor shall be granted reasonable access to the system to fulfill the obligations set forth in this Contract. G.3.Conformance Standards: All services shall be performed and software shall function in conformance with all applicable VA safety and Security standards, manufacturer's/industry standards, HIPAA, Section 508, OSHA, NEC, FDA and other applicable state, local, national and industry standards. G.4.Payment: Invoices for CLIN Tasks 001 to 006 will be submitted by the vendor as work is completed. G.5.Additional Charges: There will be no additional charges for any services performed by the Vendor without the written approval of the CO. Vendor understands that this is a firm fixed price contact and the Contract Price is all inclusive for all services and products defined herein.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/OCVAMC635/OCVAMC635/VA25614R0188/listing.html)
 

Document(s)

Attachment
 

File Name: VA256-14-R-0188 VA256-14-R-0188.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1165120&FileName=VA256-14-R-0188-002.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1165120&FileName=VA256-14-R-0188-002.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: Central Arkansas Veterans Healthcare System;2200 Fort Roots Drive;Bldg 170, Unit 3J, Office 110 “ (this is my specif;North Little Rock, AR 72114

Zip Code: 72114
 

Record

SN03268947-W 20140118/140116234109-d6f7b6a1e057c8a49510b151e2fea96e (fbodaily.com)
 

Source

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

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