INTENT TO SOLE SOURCE The VA Pittsburgh Healthcare System intends to negotiate on a sole source basis with GE HEALTHCARE, 101 CARNEGIE CENTER, PRINCETON, NJ 08540 to provide TELEMETRY MONITORING CARESCAPE SYSTEMS in accordance with FAR 13.106-1. GE HEALTHCARE is the only manufacturer and distributor of the CARESCAPE SYSTEMS This Notice of Intent is NOT a request for competitive proposals. Parties may identify their interest; accompanied by supporting literature, to the Contracting Officer no later than AUGUST 15TH, 2017 NOON EST est. ALL Responses should be sent to
[email protected]. No telephone responses will be accepted. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. The NAICS Code for this procurement is 339112. Contracting Office Address: Attn: Amanda Saunders, Department of Veterans Affairs Network Contracting Office 4, 1010 Delafield Road Pittsburgh, Pennsylvania 15215-1802 PERFORMANCE BASED WORK STATEMENT 1. GENERAL: The vendor, GE, or equal, shall provide the equipment, upgrades, warranty, and training necessary to update our existing GE Telemetry System as specified in this documentation. 2. BACKGROUND: The Erie VAMC is located in Erie, PA encompassing acute medical, surgical, psychiatric, and long-term care. The hospital provides primary, secondary, and some tertiary care. Annually, the medical center serves approximately 18,000 patients. 3. PERIOD OF PERFORMANCE: FY 17 Q3/Q4 4. PLACE OF PERFORMANCE: 135 East 38th Street Erie, PA 16504. 5. DAYS AND HOURS OF OPERATION: Monday Friday, 0730 to 1630. excluding federal holidays. 6. EQUIPMENT DESCRIPTION: 7. PERFORMANCE REQUIREMENTS: The Vendor will upgrade our current GE telemetry system including: Software updates to associated telemetry and monitoring software currently being used by the Erie VAMC. This will include upgrades and replacements to computers if needed in order to run new software installments The operating system for the central station computers will be Windows 7, 64 bit. This will include a new server, with an operating system of Windows Server 2012, but no less than Windows Server 2008 or a Linux operating system. The server will be the point of interfacing with VISTA and CPRS. Refer to section 8. SCOPE OF WORK FOR INSTALLATION for information on the installation of the requested equipment. Clinical Training: The Contractor must provide a training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training defined in the Contractor s FSS Contract. Training will be unlimited and include initial setup and user-training; onsite training for go-live support, super user training, and follow-up training. Training will include ongoing customer support after the implementation of the equipment, as well as annual applications training for the duration of the warranty. The following list of equipment will be repurposed by the Erie VAMC: Strip Chart Recorders Telemetry Transmitters Antennas All equipment that is not reused will offered as a trade-in. Urgent Care Center: Eight (8) new B650 physiological monitors with Patient Data Modules (PDM) capable of monitoring end tidal CO2, ECG, SPO2, and noninvasive blood pressure. Two (2) B450 transport monitors, with Patient Data Modules (PDM), capable of monitoring end tidal CO2, ECG, SPO2, and noninvasive blood pressure. All monitors must utilize Masimo technology for SPO2 measurements Vendor will include one (1) set of ECG cables and leads, SPO2 finger sensors, non-invasive blood pressure cuffs of each size, and exhaled CO2 sensors and interconnecting cables for each monitor. One (1) upgraded Central Station (Windows 7, 64 bit), one (1) new laser printer and all interconnecting cables. Vendor will supply an uninterruptable power supply, sized to maintain power to the CIC monitor and computer for a minimum of 10 minutes. Six (6) of the mounts will need to be capable of attaching the headwall rail and 2 of the mounts will need to attach directly to the wall. Unit 5 Acute Care All telemetry transmitters will be compatible and capable of connecting to the GE Healthcare Carescape V100 vital signs monitor and the Dyna Link adapters for the transmission of non-invasive blood pressure values to the central station Vendor will include patient leads and SPO2 sensors and Dyna Link adaptor, and cables, compatible with the GE Healthcare Carescape V100 vital signs monitor, for the telemetry transmitters Two (2) new B450 physiological transport monitors, with Patient Data Modules (PDM), capable of monitoring end tidal CO2, ECG, SPO2, and noninvasive blood pressure. The B450 must have the full arrhythmia package Vendor will include one (2) roll stand for the B450 transport monitor Vendor will include 1 set of ECG cables and leads, SPO2 finger sensors, non-invasive blood pressure cuffs of each size, and end tidal CO2 sensors and interconnecting cables for the B450 transport monitor. One (1) upgraded Central Station (Windows 7, 64 bit), one (1) new laser printer The Central Station (CIC) must have the full arrhythmia capability, 72 hour full disclosure, post-discharge data and all Clinical Tools, ie., care notes, event review, strip reporting, etc. The Acute Care CIC will be interconnected to the CIC in the Urgent Care Clinic and be capable of viewing patients in the Urgent Care Clinic while continuing to monitor all telemetry patients. Vendor will supply an uninterruptable power supply, sized to maintain power to the CIC monitor and computer for a minimum of 10 minutes. Operating Room Four (4) new B850 physiological monitors, with Patient Data Modules (PDM) capable of monitoring end tidal CO2, ECG, SPO2, Smart Anesthesia Modules and noninvasive blood pressure. The B850 monitors will mount to the existing mounts and must have the standard VESA mounting configuration. Three (3) new B650 physiological monitors with Patient Data Modules (PDM) capable of monitoring end tidal CO2, ECG, SPO2, and noninvasive blood pressure. The B650 monitors will require new mounting hardware. The mounts must be capable of being mounted to the wall and capable of Vendor will include 1 set of ECG cables and leads, SPO2 finger sensors, non-invasive blood pressure cuffs of each size, and exhaled CO2 sensors and interconnecting cables for the B450 transport monitor. One (1) new B450 physiological transport monitor, with Patient Data Modules (PDM), capable of monitoring exhaled CO2, ECG, SPO2, and noninvasive blood pressure. Vendor will include 1 set of ECG cables and leads, SPO2 finger sensors, non-invasive blood pressure cuffs of each size, and exhaled CO2 sensors and interconnecting cables for the B450 transport monitor. All monitors must utilize Masimo technology for SPO2 measurements One (1) new B450 Roll Stand Server The vendor will provide and install the server. The server will be physically installed in the Information Technology server core room, which is located in the basement, room B018-1. The server must be 4-post rack mounted, 120 volt Vendor will provide the HL7 interface to VISTA. Must have an operating system of Windows Server 2012, but no less than Windows Server 2008 or a Linux operating system. Biomedical Department One (1) new Central Station, one (1) new laser printer 8. WARRANTY: The Erie VAMC is requesting a 3 year warranty on all new and upgraded equipment. Any equipment that is being reused will not be covered under the warranty. 9. SCOPE OF WORK FOR INSTALLATION The vendor must provide a turn-key installation that must include all hardware, cabling, and accessories for a complete system (excluding devices stated to be reused) including but not limited to servers, monitors, modules, mounts, cabling, switches and uninterruptable power supplies. The following list of equipment will be repurposed by the Erie VAMC: Strip Chart Recorders Telemetry Transmitters Antennas The Vendor will contact the Contracting Officer s Representative (COR), Carol Vance, by phone (814) 860-2404, to arrange for a pre-installation meeting, with all effected services and the vendor. Meeting must occur within 4 weeks after the award of the contract. Installation/Site Preparation: Site preparation specifications must be furnished in writing by the Vendor as a Site Preparation Report after award of the delivery/task order. The Vendor must provide coordinated professional installation and implementation project management services to implement the system specified in the SOW. The Vendor must provide a firm estimate of working days required from date of delivery order to go-live based upon the SOW. The initial installation site report must be provided to the COR no later than two weeks after the per-installation meeting. Vendor must visit the site and agree to the location of equipment and determine specific site prep requirements including but not limited to: Space availability Power availability Configuration of mounts, modules, and peripheral equipment. Infection Control Risk Assessment The telemetry configuration and networking currently not functional will be implemented in the 5th floor acute area. The telemetry central station will have an interconnection with the central station in the Urgent Care Clinic. The vendor will include a gateway server to enable the interface connection of both central stations to VISTA. That connection will not be performed during this installation, but should be capable of that connection in a future project. The Ambulatory Surgery monitors will be connected to the PICIS computers for the transfer of patient data to VISTA. The vendor must provide the drivers for the monitors to interface with the PICIS computers. The vendor will install the antenna and cabling on the 5th floor. The cabling will be run into the Engineering closet, room # SP535-1 and down thru the existing conduit to the 3rd floor Engineering closet, room 351. From the 3rd floor closet the cable will be run above the ceiling and into room 303, which is across the hall from the Engineering closet. The telemetry receivers, filters and power supplies for the filters will be mounted on the East wall of room 303. The existing data drop will be utilized to connect the receiver to the network in room 302 (IT closet). The receiver will use the network cabling to connect to the servers in the IT server core room. Contractor must provide a turn-key installation that must include all hardware, cabling, and accessories for a complete system, including but not limited to, servers, monitors, modules, mounts, cabling, network switches and uninterruptable power supplies. 10. VENDOR RESPONSIBILITIES: All installation of antennas, cabling of antennas, receivers, telemetry peripheral switches will be installed by GE Healthcare. Vendor will perform an RF survey, on Unit 5, prior to installation. Vendor will work with COR and Information Technology Representative to determine the best location for networking components, based on the location of the existing network components. All above ceiling cabling must be tie-wrapped and placed in either the telephone/data trough, in a conduit, or properly routed through interstitial areas per hospital facilities requirements and local electric codes. Cables must be bundled neatly and in a professional manner especially when cables converge at network hardware. Cables must be marked at each end indicating the termination point of the other end. Any cable run through plenum space must be plenum rated according to NEC and applicable fire codes. Any firewalls that are breached must have the openings sealed with a properly rated fire stop sealant. All networking hardware must be rack mounted in the rooms designated by Facility Project POC or COR to be provided at walkthrough. Network cabling, terminations, and any patch panels used must be Category 6 (Hereafter referenced as CAT6) certified. All cables must be terminated TIA568A in conformance with Telecommunications Industry Association standards. All cable runs must be tested and certified in accordance with TSB-67 and TIA/EIA 568-A or latest TIA/EIA Revisions. The Contractor must provide a copy of all test results along with all cable lengths to the COR in an acceptable electronic format that can be displayed and/or viewed. Contractor must comply with all VA mandated and local permitted/safety requirements. Performance verification will be required at the conclusion of every preventive maintenance and emergency repair event. This verification procedure may include performance testing for accuracy and precision of the instrument. If any procedures were performed that would in any way affect the calibration status of the instrument, the results of performance testing must conform to established performance criteria for the instrument. 11. GOVERNMENTS RESPONSIBILITY: Entry into all spaces required to complete the installation All electrical power required for the equipment Any data drops needed for connection to the network Space for the equipment to be installed Storage space for all new/upgraded equipment and during the installation phase a staging area for the vendors tools and equipment. 12. SECURITY: Upon arrival at the VA Medical Center, the vendor shall stop at the VA Police office and obtain a contractor s badge . The vendor will proceed to the areas where the installation will be performed. 13. INFORMATION SYSTEMS SECURITY REQUIREMENTS: GENERAL 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. With regard to background investigation requirements, the Office of Operations, Security, and Preparedness (OSP), has determined it is not required for contract personnel with limited and intermittent access (installation and repairs as required or requested by VA staff as part of the approved contract) to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment. Therefore, maintenance (warranty) and installation contracts are exempt when a Business Associate Agreement (BAA) is in place. 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). 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 1605.05, Business Associate Handbook. Absent an agreement to use or disclose protected health information, there is no business associate relationship. 4. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE (if applicable include the following statement per memo 3/24/2011) Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 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 ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. Based on the determinations of an independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 7. TRAINING Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis electronically through TMS either: (i) the VA security/privacy training (contains VA s security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA s contract have received their annual security/privacy training that meets VA s requirements and the total number of employees trained. Sign VA s Rules of Behavior: Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign electronically through TMS, on an annual basis, an acknowledgement that they have read, understand, and agree to abide by the VA s Contractor Rules of Behavior through TMS. If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA s information and information systems. 8. CONTRACT PERFORMANCE MONITORING: The government reserves the right to monitor services in accordance with Performance Based Matrix. 9. INVOICES: Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer s Representative (COR), and submitted to
[email protected] A properly prepared invoice will contain: Invoice Number and Date Contractor s Name and Address Accurate Purchase Order Number Supply or Service provided Total amount due 10. Records Management Language for Contracts The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.