Amendment to Muskogee VAMC Patient Monitoring System

This solicitation's due date for quotes has been extended to Friday, September 22nd,2023, at 12PM MST. Revisions to the Statement of Work and Price/Cost Schedule are as follows: a. 1. Background, Operating room was removed from the requirement. b. 2.3.2.3. Operating room was removed from the requirement. c. 2.3.4. Language revised to better reflect a clinical need. d. 2.3.6. Additional language added to reflect a clinal need. e. 2.3.10. Additional language added to reflect a clinical need, and operating room removed from the requirement. f. B.3. Price/Cost Schedule and SOW Line Items 0003, 0007, 0008, 0009, and 0020 have been revised to increase quantity. g. Please review the SOW and Price/Cost Schedule for details. All other terms and conditions remain unchanged. STATEMENT OF WORK (SOW) Patient Monitoring System Background This procurement supports the replacement of individual patient monitoring systems to a single patient monitoring system across the emergency department, ICU, PACU, short stay, and endo, at the Jack C. Montgomery VAMC. The solution shall be comprised of both hardware and software along with components designed to monitor, collect, analyze, and alert clinicians to a change in various parameters. The physiologic monitoring system shall measure and display waveforms and various parameters, such as blood pressure, temperature, pulse rate, etc. to the medical and nursing staff about the patient and used in treatment decisions. The requirement also includes telemetry coverage for each department, and all adjacent corridors utilized for patient transport. Lastly, the requirement is for central monitoring capabilities for each department. The individual monitoring systems at the VAMC are antiquated and do not communicate across departments posing a patient safety risk. In addition, the current physiological monitoring system is not compatible with the existing GE Muse Cardiology Management system, existing GE anesthesia machines and associated peripheral equipment. The new system shall not interfere with the operation of currently owned GE systems. Scope of Services This requirement is for a complete turnkey solution for a single patient monitoring system at Muskogee VAMC. The requirement includes all equipment, mounting components, interface components, networking components, infrastructure components, materials, installation and training necessary to operate the system. Current support requirements are for a 50-bed inpatient facility with the capability to expand coverage as needed. Equipment must be FDA approved. Technical Requirements The system must provide continuous monitoring of patients at bedside and via telemetry through a facility wide infrastructure. The system must be compatible with the Risk Management Framework requirements for the VA network and have an existing risk analysis completed. There are three main components within this system: A bedside monitoring suite: services multiple units via a central server that provides display, communication, and processing for patient physiological data with recording capability from any monitor in the facility. A cardiac telemetry system that also provides a record capability of patient data and waveforms using wearable telemetry packs that transmit ECG an SPO2 physiological data over a network to a central monitoring server for viewing and analysis. A central monitoring system capable of seeing all monitors within and between departments to include, emergency department, ICU, PACU, short stay, and endo. The central monitoring system shall consist of an LCD monitor and the ability to print. The system shall include the licenses, software, and accessories required for critical care, full arrhythmia, 12 lead ECG, temperature monitoring, respiratory modules, combo telemetry ECG licenses, invasive blood pressure monitoring, ICU critical care monitoring, anesthesia software as appropriate per department use. The system shall communicate directly with VISTA and CPRS, not requiring additional data interfacing. The system shall also communicate bidirectionally with the facility electronic health records (Currently VISTA/CPRS) and shall be adaptable to Cerner at no cost to the government. The product must be established on the Cerner supported and certified medical device list. The requirement shall include the ability to print patient data from the central station to one thermal EKG strip printer. The system shall have configurable alarms. The patient monitoring system shall have the ability to export telemetry reports from the central station in a downloadable fashion, not requiring external storage device. The system shall be compatible with existing supply of peripheral sensors and cables'SPO2 probes adult/pediatric/neonate, BP cuffs, temperature probes, and thermometer probes. The system shall be compatible, interface and allow complete functionality of the existing GE MUSE system, GE anesthesia devices, GE Airstrip, and GE EKG machines regardless of existing version (backwards and forwards compatible). GE MUSE functionalities that shall be maintained after the installation of the new patient monitoring system are: - Serial Comparison which allows the clinical team to trend previous 12 lead studies with new 12 lead studies. Ability to pull 12 lead studies from the Muse to a bed side monitor. GE AISYS CS2 ANESTHESIA MACHINE functionalities that shall be maintained after the installation of the new patient monitoring system are: Preset features, Multiple ventilator modes, The option to give a vital capacity breath. GE EKG functionalities shall be maintained after the installation of the new patient monitoring system. Required to be capable of capturing physiological data when a patient is connected to the system and having that patient information available to relevant providers wherever they may be in the facility. GE MUSE functionalities that shall be maintained after the installation of the new patient monitoring system are: - Serial Comparison which allows the clinical team to trend previous 12 lead studies with new 12 lead studies. Ability to pull 12 lead studies from the to a bed side monitor. GE AISYS CS2 ANESTHESIA MACHINE functionalities that shall be maintained after the installation of the new patient monitoring system are: Preset features, Multiple ventilator modes, The option to give a vital capacity breath. GE EKG functionalities shall be maintained after the installation of the new patient monitoring system. Monitors must be bedside, or wall mounted, and wall mounted units must be detachable. All hardware and labor to mount the monitors must be included. It shall also include bed mounting rail kits and pole mounting kits. Units must be compatible with all mounts located in the emergency department, ICU, PACU, short stay, and endo. Central monitoring stations must be interconnected to offer cross-coverage of monitoring capability by any central monitoring station. They must include a UPS for each station. The central station must also include configurable audible and visual alarms and include at least a 19 display. It shall include all batteries, docking stations with chargers, and all cables/power cords necessary to use the system. The cables shall have USB connectors to connect future capabilities. Item Item Description Qty Unit 0001 HL7 Upgrades 1 EA 0002 HL7 License Expansion 1 EA 0003 12-inch screen bedside physiological monitor with transport capabilities, with associated wall mounting, hardware, and accessories 43 EA 0004 12-inch screen bedside physiological monitor with transport capabilities, with associated roll stands, hardware, and accessories 5 EA 0005 12-inch screen bedside physiological monitor with transport capabilities for Biomed Spare (no mounting required) 1 EA 0006 Bedside Central Stations 7 EA 0007 15-inch screen bedside physiological monitor with associated mounting, hardware, and accessories 21 EA 0008 19-inch screen bedside physiological monitor with associated mounting, hardware, and accessories 0 EA 0009 7-inch screen transport physiological monitor for intra-hospital transport with associated mounting, hardware, and accessories 64 EA 0010 Primary Cerner Integration 1 EA 0011 Backup Cerner Integration 1 EA 0012 Cerner Integration advanced features 1 EA 0013 Project Management Pre-Go Live 6 EA 0014 Web interface to view Static and Continuous Cardiology Waveform modules, and Snippets 5 EA 0015 Network Drop Install w/Cat6, Dust Carts 60 EA 0016 Network Fiber Run Install - Dust Carts 6 EA 0017 Network Equipment - Standard (Minimum 7 nodes) 70 EA 0018 Network Equipment Install (Minimum 7 Nodes) 70 EA 0019 Network Design/Consult Seg Network - 15+ Nodes 56 EA 0020 Network Equipment -UPS (Per 20 Nodes) 7 EA 0021 Network Design/Consult Seg Network - <15 Nodes 14 EA 0022 Telemetry wireless coverage installation for 212,000 square feet 1 EA 0023 Telemetry Servers 3 EA 0024 Telemetry Receiver with 4 Receiver Cards (4 telemetry patients per card) 3 EA 0025 Networking Documentation Kit & Labels 1 EA 0026 Clinical Applications Training for Patient Monitors 10 EA 0027 Configuration for Patient Monitors 3 EA 0028 Central Station Configuration and Training 1 EA Line item 0008: 7-inch screen transport physiological monitor for intra-hospital and inter-hospital transport with associated mounting, hardware, and accessories shall have the ability to continuously monitor and store patient data as it is used between departments. All line items: All patient monitors and infrastructure shall not diminish the functionalities of the GE Muse Alaris, and EKG. All line items: The patient monitoring system shall support Cerner's patient to device functionality. Software and Server Requirements The operating system (ie Windows 10) shall have at least 36 months of commercial availability. Unsupported software or operating systems is prohibited. Vendor shall provide server and storage specification, fill out 6550 Pre-Procurement form, provide MDS2. Vendor shall be in compliance with VA network security regulation according to VA Directive 6500 and 6550. The system shall include at least 50 regular bed licenses and vital signs information using outbound HL7 communication. Software Update/Patching: Software update and/or application patching are included. Vendor is responsible to coordinate with Facility Biomedical POC and work through facility change contract board prior to any update and/patching. VA Biomedical POC is responsible for Window security patch after vendor approves the patch. VA Biomedical shall be able to login, restart, shutdown and preform basic maintenance on servers. Professional Service Project Management: Contractor shall provide a Project Manager with a thorough project plan deliverables such as: Project Schedule to include Milestone, Deliverables, and Critical Path Verification & Validation Plan Training Plan Risks Management Plan Operations & Maintenance Plan Emergency Operation Plan Project Close out Activities/Procedures A minimal of weekly and/or AS need project meeting Professional Service for Clinical and Technical: including but not limited to: installation, configuration, clinical training, work flow re-evaluation and recommendation and testing, integration testing with DSS/Databridge, Vista/CPRS and/or associate medical equipment. All network design/consultation will be included All configurations needed will be included Installation of entire system will be required, including any wiring, fiber, and drops that are needed All dust containment needs will be provided during installation Connectivity of entire system will be required Testing of all connectivity and functionality will be completed before handing over for use The requirement must include 1 BESS training slot and 10 user training slots. Maintenance Requirements Operator, maintenance/service and training manuals shall be provided. One paper format and two digital format copies are required. Vendors must provide a system schematic once the system is installed and a data workflow diagram. At least a one-year warranty shall be included. System shall also include 4 years of out year maintenance listed in one-year increments for the hardware and software. Vendor shall provide local admin access to Healthcare Technology Management for support and maintenance without a service contract in place. Software and hardware warranty start on Day 1 of site - GO Live for 12 months. Hours of coverage are 24/7 Remote/Telephone support Onsite support through normal operation hours Monday-Friday 7:30am-4pm, excluding the federal holidays listed as follows: New Year's Day, Martin Luther King Jr's Birthday, Washington's Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled preventive and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance), by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment. The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request. The Contractor shall perform PM Service to ensure that the equipment listed performs in accordance with the original manufacturer's specifications. An outline of the PM schedule and procedures shall be provided to the Biomedical Engineer. The contractor shall provide a written description of the Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following: Cleaning of equipment. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer's specifications. calibrating and lubricating the equipment. Performing remedial, non-emergent maintenance. Testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn. Inspection and replacement of worn or frayed electrical wiring and cables. Returning the equipment to the operating condition and mode. Providing documentation of services performed. All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. The only exception is hardware/software update/upgrade installations which shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the Biomedical Engineer). The contractor shall provide software/hardware updates at no charge. All exceptions to the PM schedule shall be arranged and approved in advance with the Point of Contact, or Biomedical Engineer. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the Point of Contact at the completion of the PM. Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge. Unscheduled Maintenance The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer's specifications. Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the CO has the authority to approve/request an unscheduled maintenance service call to the contractor. If vendor perform workstation repair offsite, workstation shall be return upon repair with the same equipment serial number. Returning a workstation with a different serial number is not authorized. There shall be no hourly charge to the Government for unscheduled maintenance performed within the normal hours of coverage, 8:00am MST to 5:00pm MST. Work performed outside the normal hours of coverage, at the request of the Biomedical Engineer, Point of Contact, or Contracting Office Representative, shall be invoiced separately and shall not have service rendered until Purchase Order is obtained. In the event of a Government caused delay, the VA will pay hourly labor charges for unscheduled service the inadvertently extends beyond the specified normal hours of coverage. Response time The Contractor shall provide the upgrades, maintenance and technical support within a specified time published in the response time requirements below in Table 1. If the problem cannot be resolved over the phone or remotely, then an authorized representative of the company will commence work within the designated time identified and will proceed progressively to rectify the problem without undue delay without any additional cost to the government. The Contractor shall be responsible to coordinate the method of response with the COR. Urgent priority is defined as any issue that affects patient safety, regulatory compliance, and/or GE monitoring interfaces which affect life and/or property. Urgent priority applies when malfunction or failure can result in patient injury or death or significant damage to equipment. This includes any issue that adversely impacts patient care. Examples include partial or complete system outages, interruptions making a critical functionality inaccessible, interruptions causing a severe impact on application availability, or data corruption resulting in missing or incorrect patient information, duplicate records, loss of data, etc. Urgent priority requires immediate action by the Contractor. High priority is defined as having a potential to affect patient care such as degradation in performance or functionality, work flow interruptions or delays, etc. High priority warrants special attention and takes precedence over normal and low priorities. Examples include interruption to critical functionality, access denied to data and systems, sustained degraded or unusable capabilities, not life threatening but having a potential for impact on services availability if not resolved. High priority also requires immediate action by the Contractor in order to minimize risk of becoming an urgent priority event. Normal priority is defined as a defect or fault event but the system is operable with no impact to patient care. Normal priority requires same day initial action but resolution may take more time. Examples include impairment of non-critical functions or procedures, capabilities that have become unusable or hard to use but with no direct impact on patient care services or system availability. Normal priorities will typically have a workaround available. Normal priorities take precedence over low priorities. Low priority is defined as preventive maintenance or issues that do not require immediate action or attention. Table 1 list response times by priority types as defined by VA. The Contractor shall meet the response time requirements associated with each priority: Priority Call Back Response Remote-Log In Response Turn Around Time (to restore to full performance) Urgent 1 hour 1 hour 8 hours High 2 hours 2 hours 16 hours Normal 2 hours 8 hours 40 hours Low 4 hours 10 hours 48 hours If Full Performance cannot be restored within the above timelines an on-site response may be required as agreed upon by VA and Contractor. Full performance means that all defective software, hardware and/or parts have been replaced with equivalent to or better than the original manufacturer's parts and that replacements meet or exceed the manufacturer's original performance specifications. Interface requirements As part of the unscheduled and scheduled maintenance, the Contractor shall ensure that all GE monitoring including but not limited to, VistA, VistA Imaging/CPRS, Medical Devices, analytics, and data transfer links are maintained consistently throughout the period of performance. The Contractor shall coordinate with other Vendors and/or Contractors when necessary to accomplish this task Medical Device Interface Support The Contractor shall coordinate with other Vendors and/or Contractors when necessary to accomplish this task. The Contractor will provide additional device SW interfaces software during the performance period and shall perform all work associated with new medical device interfaces requested during the performance period at no additional cost. The new device interface software will be pre-approved by the COR and GE and scheduled in advance to avoid any gaps in the patient monitoring records. Contract includes only updates or new quantities of already purchased SW Protocols. If site purchases different manufacturers devices, a new protocol will be required at then current FSS prices and included in the monthly invoicing fee for that site. In addition, the Contractor shall provide all associated additional and replacement interface cables for already purchased interfaces. Invoicing will be included in the regular monthly invoice, in arrears, and will only be in the amount actually used and using the current contract FSS pricing schedule. The Contractor shall coordinate with other Vendors and/or Contractors when necessary to accomplish this task. Optional Task Order Description Unit Qty Additional monitor and license (same spec in 2.2) ea 10 Additional network drops ea 20 Additional user training job 5 Additional Offsite Biomed Training job 1 Additional Professional and Project Management is per hour hour 500 Additional Software Upgrade to latest version ea 4 Annual Hardware and Software maintenance (1 year option for 4 years) ea 4 Delivery Department of Veterans Affairs, VISN 19, Jack C. Montgomery VA Medical Center, Muskogee, OK. 74401. Site POC is Victoria Smith: contact@example.gov. The contractor will have all the products delivered and installed at Muskogee VAMC. Contractor delivery of equipment shall take place between the hours of 0800 -1500, Monday through Friday. Contractor shall not be required, nor is authorized to perform any work on the following U.S. Government Federal Holidays. Security Requirements Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Access to VA information and VA information systems A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA information custodial language Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. Security incident investigation The term - security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated IS...