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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 12, 2016 FBO #5376
DOCUMENT

65 -- Operating Room Integration System - Attachment

Notice Date

8/10/2016
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street Trafficway;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25516Q0789
 

Response Due

8/15/2016
 

Archive Date

10/14/2016
 

Point of Contact

Eric M Murray
 

E-Mail Address

6-1978<br
 

Small Business Set-Aside

N/A
 

Description

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses. Responses to this notice shall include: 1.Company Name 2.Address 3.Point of Contact 4.Phone, Fax, and Email 5.DUNS number 6.Cage Code 7.Type of business, e.g. Service Disabled Veteran Owned Small Business, Veteran Owned Small Business, 8(a), HUB Zone, Women Owned Small Business, SDB 8.Must provide a capability statement that addresses the organizations qualifications and ability to perform the work described below: Operating Room Integration System I. INTRODUCTION The Harry S. Truman Memorial Veterans Affairs Medical Center (hereafter referred to as Truman VA) is seeking a new Operating Room (OR) Integration System to include integration of Audio, Video, Medical Equipment, Picture Archive and Communications System (PACS), and Information Systems. The OR suite was constructed in 2013 with a total of 39,000 square feet. The original system that was installed during the construction is in need of replacement due to it reaching obsolescence and many of its components no longer being able to be maintained. In order to ensure the availability and proper function of the integration equipment, for optimal operating efficiency, Truman VA is seeking a new, state of the art, integrated, fully functional OR Integration System. II. PROJECT DESCRIPTION This project shall include the OR Integration System, high definition medical grade displays, equipment control, installation, maintenance, warranty, and training of operating and service of the integration system. Contractor shall connect the system via VA Local Area Network (LAN) to allow the archive of surgical pictures and video to Vista Imaging. Contractor shall provide all labor, material, tools, equipment, technical service manuals, training, delivery, staging areas, and accessories necessary to furnish and install the equipment defined herein. The contractor and product shall meet or exceed all relevant state and federal regulations, standards, and codes, such as: NEC, NFPA, OSHA, JCAHO, NEMA, FDA, and NIST. This project does not include surgical lights and booms. III. SCOPE OF WORK The contractor shall provide a total integrated platform solution for the Truman VA. The total integrated platform shall include eight Operating/Procedure Rooms: one Ophthalmology OR, one General Surgery OR, two Cardiac ORs, one Endovascular OR, one Orthopedic OR, one Cystoscopy OR, and one procedure room. Each of the eight rooms listed above shall have a minimum requirement of a 1080p Medical Video System, but higher quality may be provided (e.g., 4K). Flexibility shall be designed into the integration system to enable use of each operating room by as many surgical specialties as possible (requires additional ports/displays/interfaces than what is currently installed). All rooms require the capacity to perform a broad range of surgical services. The basic requirements for the eight rooms are for the contractor to provide the following: one all-in-one high definition video routing integration system, one uninterruptable power supply, one ceiling mounted plate, one ceiling mounted plate assembly, one fiber optic/digital visual interface cable assembly, one information management and digital image and video capture device with device control and DICOM conformance, one advanced imaging modality camera control unit, two advanced imaging modality camera heads with integrated couplers, one LED light source, one insufflator, one real-time video enhancement device, one digital color printer, four 26" LED Displays with device control kits, four protective display covers, four ceiling speakers, one mp3 docking station, and other accessories as identified by the contractor for the proposed system. The contractor shall provide installation, warranty, and training for all items listed above. The contractor shall provide servers and database storage hardware, software and licenses to host the media management system, integration with the EMR, and integration of all OR integration systems into one system that shall be installed in the Biomedical Engineering Data Center. The system shall include all necessary pre-installation manuals, technical service manuals, operating manuals, instructions for use, and cleaning procedures. The contractor shall provide engineering services, professional services, and project planning services as necessary during normal business hours 8 a.m. - 4:30 p.m. Monday-Friday (excluding all federal holidays). Installation shall be priced for and performed during nights (6 p.m. - 5 a.m.) and weekends. The contractor shall provide adequate end-user training to allow for multiple classes for alternating/rotating users. The contractor shall provide two Biomedical Engineering training packages - these training packages shall include all prerequisite classes, equivalent to what OEM field service representatives receive. The OEM shall also provide all service manuals, schematics, diagrams, diagnostic software, other special tools and hardware keys equivalent to what their field service representatives have available to diagnose, troubleshoot, repair and maintain the equipment. Travel including airfare, hotel and government rate per diems shall be included. Note: OR booms, lights, and in-light cameras are provided as existing equipment and are not part of this requirement. IV. PRODUCT DEFINITIONS Video Integration System: The term "Video Integration" will be used to describe the digital OR video integration and media management system. The video integration system is intended to be a central point of control and integration of ancillary equipment, audio, video, and data routing, as well as teleconference for medical personnel and students. The media management system will centrally store, archive, and manage surgical videos and images. The integration system with digital capture devices sends surgical videos/still images to the hospital information system. Endoscopy System: The Endoscopy System includes a Digital Capture Device, a Light Source, an Insufflator, and a Digital Color Printer. The Digital Capture Device is an information management and digital image and video capture device with device control and DICOM conformance. The Light Source provides medical quality lighting to endoscopes. The Insufflator is an apparatus used to blow gas into a body cavity. The Digital Color Printers provide printing capabilities for selected cases. V. PRODUCT REQUIREMENTS It is recognized that each contractor's product line may differ from the following specifications. As such, contractors are free to propose variances from these specifications. It is required, however, that whenever a variance from these specifications occurs, the proposed item meets or exceeds the specified characteristics or level of performance. The contractor's proposal shall identify each product line item that differs from the specifications. If a specific item or capability specified is unavailable, alternatives may be proposed. If a functionality is in development, the contractor shall comment on its future availability by providing details on its design and development status, pending or current clinical trials (if applicable), the planned start of manufacturing and deliveries, and Food and Drug Administration (FDA) and/or EU pre-market approval status (if applicable). Product solution must not alter or change the current space and utility design. OR Video Integration System: The system shall be able to provide high definition quality live imaging from almost all applicable medical devices or digital image sources, regardless of type of device, signal source, or connection type. The system shall bring audio, video, and data sources to a centralized point where they can be controlled and routed using a touch panel interface with open-architecture framework. The system is able to accommodate virtually all high definition signals regardless of manufacturer or signal type. The system shall integrate with designated medical devices, PACs, Image Interfaces, Surgical Navigation System, Endoscopy System (camera control unit, light source, insufflator, and digital capture), Mobile C-arms, and Patient Monitors. Furthermore, the system shall provide a Time Out verification capability that meets Joint Commission and World Health Organization compliance. The project requirements call for both surgical time out verification and hospital information systems integration for patient safety practices. The system must have a collaborative feature that interfaces with the system and provides for surgical time out and real time patient information via the surgical integration system. In addition, the system shall provide for control of all endoscopy systems and surgical lights from the central station. The system shall have the ability to interface and route images from in-light cameras in surgical lights. The system shall have the capability to handle video-conferencing in up to 1080P, control of call with far end video shall have the capability to be routed to any display. The system shall be capable of routing telephone calls from VA Voice over Internet Protocol (VoIP) desk phone and bi-directional audio communication. The mp3 docking shall be able to integrate with the speaker system. System will provide touch screen control of video source selection, and video routing. Clinical staff shall be able to manipulate VA information systems on the same workstation controlling video routing and viewing of video feed from another active video integration solution within the hospital. The integration system shall be able to broadcast audio and video to any point on the network. Live or stored video images shall be able to be readily displayed throughout the hospital (and beyond) for teaching, mentoring, or supervision. The connection to stream the live video shall have administrative access logs and view and edit logging for HIPAA compliance. The Video Integration System must be contractor neutral and accept a wide variety of inputs from all types of medical equipment manufacturers. The system shall be able to support touch screen control of video source selection and video routing. Multiple video sources displayed on a single display and the ability to concurrently display more than one input device with same video input. The media management system shall centrally store and archive all surgical media via server and database infrastructure. It must be capable of clipping video segments, capturing images, and annotating original surgical video. The system should allow clinician to share surgical case media internally within Truman VA community and Microsoft Office suite files (e.g., PowerPoint) with edited surgical media for educational purpose. At postoperative, the surgical case shall be pushed to VA Vista Imaging. Clinician must be able to review surgical content in Vista Imaging, OR Integration workstation, or web application through Windows Internet Explorer. Contingency Plan Capabilities: In the event of VA network failure, at minimum, the video integration and video capturing device shall operate without interruption. If a monitor fails, operator should be able to reroute video to another monitor without any physical infrastructure change or re-cabling. Contractor is required to work in conjunction with the clinical staff to develop a contingency plan in the event the integration system fails during a surgical case. Endoscopy System: Each endoscopy system shall be mounted on the equipment arm of the surgical boom in each OR. The digital capture device must accept any endoscopy source such as, but not limited to, Karl Storz, Olympus, Pentax, and Stryker. The Digital Capture Devices shall be a bright intuitive touch screen display for ease of use, capture video in high-definition with standard and widescreen aspect ratios, have DVD video and real time burning options, write to multiple mediums: USB, external, CD, DVD, FTP, and PACS, have multiple video recording formats: MPEG1, MPEG2, MPEG2HD, have multiple still image capture formats: JPEG, BITMAP, tiff, TGA, and PNG, with landscape and portrait capabilities, have Vista Imaging/DICOM compatible-Query & Retrieve capabilities, load patient information with ability to archive at least 500 cases, provide customizable user profiles. The Light Sources shall be LED. They shall automatically go into standby mode if either the light cord or scope end becomes disconnected. They shall have illuminated intuitive touch screen controls integrated with camera control and camera/coupler kit. They shall allow connection to any scope manufacturer. The Insufflators shall provide CO2 gas into the abdominal space. They shall have a bright LCD touch screen for clarity and easy menu navigation. They shall provide 45 Liters of flow to better maintain set abdominal pressure; have 4 separate modes: high flow, pediatric, bariatric, and vessel harvest; have spring loaded tube set connections for easy connection and removal; have real time pressure sensing tubing for improved abdominal pressure reading; and have heated tubing to help reduce fogging and alleviate post-operative pain for patients. The Digital Color Printers shall communicate directly with the Digital Capture Device. They shall have an on screen display of remaining paper and ink which alerts the OR staff to prepare for replacement of these items. They shall have a removable loading tray for paper and ink facilitating the ease of replacement away from the sterile field. They shall laminate each sheet as it is printed which will prevented the photos from becoming wet and smearing. VI. PROJECT MANAGEMENT SERVICES The offeror shall deliver a contractor project management plan (CPMP) that provides the following information: project organization and leadership, and resource management plan; project schedule to include milestones, deliverables, and critical path; verification & validation plan; training plan; scope management plan; risk management plan, including system failure contingency plan; operations & maintenance plan; and project closeout activities/procedures. The CPMP shall document the contractor's approach, timeline, and tools to be used in execution of the contract. The CPMP shall take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The initial baseline CPMP shall be approved within 30 days of contract award and updated monthly thereafter, or as mutually agreed upon by the contractor and Government. The contractor shall update and maintain the VA Project Manager approved CPMP throughout the period of performance. There are four phases of the project that shall require an implementation team review: Phase I: Pre-installation OR Integration infrastructure Estimated Start Date: Upon contract award Estimated Completion Date: Estimated 3 months after contract award Deliverables: System configuration record including as-built, and cable run and outlet/ports for video input and system design Phase II: Installation of Video Integration System and Endoscopy System including software configuration Estimated Start Date: 3 months after contract award Estimated Completion Date: 9 months after award Deliverables: OR Integration System, Media Management System, Endoscopy systems Phase III: Integration, Verification, Validating, and Training Estimated Start Date: 9 months after contract award Estimated Completion Date: 11 months after contract award Deliverables: Training Record, Technical and Operational Manual, Technical Service Training, Revised System Configuration Record to include As-Built. Phase IV: Go Live Estimated Start Date: 11 months after contract award Estimated Completion Date: 12 months after contract award Deliverables: Contingency Plan VII. INSTALLATION, TRAINING, VERIFICATION, AND VALIDATION Installation: The contractor shall provide site specific drawings two weeks after contract award. Drawings shall provide a description of site preparation responsibilities identifying utilities, conduit, bandwidth and all other activities necessary for the Government to prepare the room. The contractor shall review and finalize the installation schedule with the Contracting Officer (CO) and Contracting Officer Representative (COR). The contractor shall furnish all cabling, tools, and hardware associated with the project scope. The contractor shall provide a plan that addresses installation responsibilities among the VA and contractor. The contractor shall attend design planning and scheduling meetings as requested by the VA. The contractor shall configure products for functionality defined in this Statement of Work. The contractor shall provide a unified installation team to improve efficiencies with the project. The contractor shall follow safety and personal conduct requirements as mandated by the VA. The contractor shall provide personal protection equipment for installation personnel. The contractor shall provide an installation project schedule and deliverables. The contractor shall protect all finished spaces and surfaces. The contractor shall be responsible for cost and repairs of any damage or noted deficiencies to finished and unfinished spaces and surfaces that occur as a result of the contractor's (or associates sub-contractors) installation. As applicable, the contractor shall take digital photographs of each barrier penetration found before and after repair and mark as-built set of floor plans with location and corresponding photograph numbers. Training: The contractor shall provide application training to OR clinical staff, including physicians. The training shall combine simulation and actual cases. The contractor shall provide onsite clinical support during go-live. The contractor shall provide follow up training for the OR clinical staff and physicians at 6 and 12 weeks intervals post go-live, if requested. The contractor shall provide a record of training to the VA COR during Phase III. The contractor shall provide training to two Biomedical Engineering Maintenance personnel. This training shall include all prerequisite classes, equivalent to what OEM field service representatives receive. The OEM shall also provide all service manuals, schematics, diagrams, diagnostic software, other special tools and hardware keys equivalent to what their field service representatives have available to diagnose, troubleshoot, repair and maintain the equipment. Travel including airfare, hotel and government rate per diems shall be included. The training shall cover the maintenance of the system as well as the servers, and shall provide written documentation about the 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, as well as system monitoring and recommended corrective actions. Two hard copies and one electronic copy of user and technical manuals shall be provided to the VA. Two hard copies and one electronic copy of service manuals shall be provided to the VA. One hard copy and one electronic copy of any other associated documentation for the integration solution shall be provided to the VA. Verification and Validation: The contractor shall pretest the entire system, upon completion of delivery/installation. After pretesting the system, the contractor shall notify the COR in writing that the system is ready for acceptance testing, and that it meets all requirements as specified above. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled government acceptance test. The contractor shall test the system in the presence of the COR, or designated representative for proof-of-performance. The acceptance testing shall be performed at a mutually agreed upon date and time. Payment will not be made until final acceptance by the Government. VIII. OPERATION AND MAINTENANCE Upon the acceptance of the system and Post Go Live, the contractor shall provide at minimum a one year warranty and maintenance of all services and parts. The VA will require access to a technical support hotline provided by the contractor 24 hours a day, 7 days a week for emergency technical services. If however, a problem or malfunction of the equipment cannot be resolved with technical support via telephone, the contractor shall be on site by the next business day. Normal operating hours are 5 a.m. to 6 p.m., excluding federal holidays. A list of federal holidays can be found on the Office of Personnel Management website. If requested by the VA, all hardware/software update/upgrade installations shall be scheduled and performed outside normal operating hours at no additional charge to the Government. The contractor shall provide repair service which may consist of calibration, cleaning, adjusting, replacing parts, re-installing software, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All parts required shall be furnished by the contractor. The contractor shall also provide unlimited telephone and on-line support for applications software and systems engineering questions 24 hours a day, 7 days a week. The Contractor shall perform Preventive Maintenance (PM) Service during the warranty period to ensure that the equipment listed in the schedule performs in accordance with the original equipment manufacturer's specifications. An outline of the PM schedule and procedures shall be provided to the COR or Biomedical Engineering within two weeks of award of the contract. The contractor shall provide a written description of each Preventive Maintenance Inspection (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but are 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; performing remedial, non-emergent maintenance; testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn; inspecting and replacing worn or frayed electrical wiring and cables; returning the equipment to the operating condition and mode; providing documentation of services performed to the COR or Biomedical Engineering. All exceptions to the PM schedule originally provided by the contractor shall be arranged and approved in advance by the COR. 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 COR or Biomedical Engineering at the completion of the PM. The contractor shall provide the software, media, software license, and software maintenance/updates, upgrades, and technical support services for any computer software identified in this solicitation. Software maintenance includes periodic updates, enhancements and corrections to the software, and reasonable technical support, all of which are customarily provided by the contractor to its customers, so as to cause the software to perform according to its specifications, documentation or demonstrated claims. Distribution of maintenance copies shall be accomplished by using the appropriate electronic or printed media. The contractor shall furnish and replace parts to meet uptime requirements. The contractor must have ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contractor shall include all non-consumable parts. The contractor shall only use new parts. All parts shall be from current manufacturer and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from another similar system shall not be installed without specific approval by the COR. The contractor shall provide fully trained staff to include a "fully qualified" Field Service Engineer (FSE) and a "fully qualified" FSE who will serve as the backup. The definition of "fully qualified" is based upon training received and on personal experience in the field. For training, the FSE's have successfully completed a formalized training program for the equipment. For field experience, the FSE's have a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive maintenance. The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. All work shall be performed and equipment shall function in conformance with all VA safety standards, manufacturer's/industry standards, the latest published edition of NFPA 99, FDA, OSHA, JCAHO, ISO 9000, UL and other applicable state, local, national and industry standards. Equipment shall meet EMS (Electromagnetic Compatibility) for EIC 601-1-2 CE, CSA, ETL Approved to U.L. 2601-1, second edition. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor shall be required to enter into a Business Associate Agreement (BAA) with VA. Prior to commencement of work on this contract, the contractor shall provide to the VAMC copies of all current calibration certificates for all test equipment to be used by the contractor on VAMC equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. The contractor shall comply with the VA Information and Information System Security/Privacy Language and the following information security and 508 compliance requirements, at a minimum: the contractor shall comply with all VA information security regulations and have an active Business Agreement Association with VHA, VA 6500 Handbook (http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=793&FType=2), VA 6500 Directive (http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=637&FType=2), VA 6550 Directive (http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=790&FType=2), and a Memorandum of Understanding-Information Security Agreement (MOU-ISA) is required if the contractor will use Virtual Private Network (VPN) access, instead of onsite support, to provide operations and maintenance of the system. Response Needed by 8/15/2016 at 0800 EST. Contact Information: Eric Murray Contracting Officer Department of Veterans Affairs Network Contracting Office 15 3450 S. 4th Street Leavenworth, KS 66048-5055 Office: 913-946-1978 Email: eric.murray@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25516Q0789/listing.html)
 

Document(s)

Attachment
 

File Name: VA255-16-Q-0789 VA255-16-Q-0789.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2934386&FileName=VA255-16-Q-0789-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2934386&FileName=VA255-16-Q-0789-000.docx

 

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

Record

SN04217909-W 20160812/160810235330-99ad17639eeba95c9998d4d9bbdefe18 (fbodaily.com)
 

Source

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

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