W065--GE OEC 9900 Workstation Rental

1 STATEMENT OF WORK WEST HAVEN VA MEDICAL CENTER G.E OEC 9900 C-Arm 1.0 OVERVIEW SERVICES: VA Connecticut Healthcare S ystem (VACTHS) requires the urgent / emergent lease / rental of a mobile C-Arm Fluoro system to address our Operating Room imaging ne eds while we work through a NAC submission to repla ce the current aging c-arm fleet. The current c-arm system is 10 years old, and it has experienced an increase in system failure over the past few months. Contractor shall provide all expertise, equipment and supplies as necessary to deliver and install the mobile OEC 9900 c-arm with the vascular package to the West Haven campus of the VA Connecticut Healthcare System (VACTHS), 950 Campbell Ave. West haven, Connecticut 06516. VACTHS staff have extensive experience operating the OEC c-arm systems. We are requesting this procurement to be sole sourced to Pursuit Medical Imaging / OEC as a vendor: This emergent situation leaves no option to include training time needed to bring our staff up to speed on different operating system. We currently complete some 60 fluoro scans per month, any procurement delays will have a negative impact on our ability to provide timely fluoro images to our clinicians and veterans. VACTHS operates an in-patient hospital with an Emergency Room and a Surgery Program, that needs 24/7 c-arm imaging to be available. VACHS currently has three older and one newer operational c-arm systems in use. The systems are used daily between the OR, Pain Unit, and the Brunch suite. These systems are used in some extremely complex procedures, and we need to provide as close to 100% uptime as possible. VACTHS has standardized on the OEC 9900 c-arm platform, we currently have three older and one newer OEC c-arms in our fleet and our staff is quite proficient on this platform and technology. This procurement would allow VACTHS to return close to normal operation in the shortest possible time, thus meeting the needs of our outpatients / customers. Contractor shall provide an GE OEC 9900, with Vascular package, which shall be delivered to the West Haven campus, VACTHS 950 Campbell Ave West Haven, CT 06095. The c-arm system shall be set up on the west haven campus in a location identified by the Contracting offer Representative (COR). After meeting a minimum lease period of 6 months, the Contractor shall be provided a minimum of 30 days notice when the unit is no longer required. If the return of the unit is anticipated to be in the middle of month, the Contractor price will be prorated, and price will be decreased accordingly. This agreement shall include all labor, material, tools, maintenance/repairs, equipment, hookup, delivery, and the complete removal of the mobile unit upon conclusion of the contract period. The c-arm unit shall be delivered and removed on a date and time mutually agreed upon between the COR and the Contractor. It is also agreed upon and understood that VA trained technologist will perform all scans on the Contractor furnished equipment. VA may need to perform c-arm procedures at any time; the VA will have on site access to the c-arm system 24 hours a day, 7 days a week (24/7) throughout the contract period. Contractor shall be responsible to maintain all the equipment in good working order and shall reimburse the VA for any reasonable costs which may be associated with any defective workmanship or equipment failure as further defined herein. All required software updates/maintenance performed by the vendor must take place after 7PM on weekdays and weekends. Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). 1.1 TERM OF CONTRACT: The contract is effective after award from the date specified for a 6 12-month period. No service shall be performed by the Contractor prior to or after contract period, unless authorized by the Contracting Officer in writing. 1.2 TRAINING: Government or government contract personnel shall provide all patient services. Contractor shall make the necessary arrangements with the Contracting Officer s Representative (COR) to schedule training sessions, if necessary. Training sessions shall not be performed on weekends and federal holidays. 1.3 USE OF EQUIPMENT: It is agreed upon and understood that a qualified technologist(s) (who has completed and received the proper training on the use of the equipment) will be authorized to use the Contractor s furnished equipment 24/7 to perform a variety of c-arm exams. This includes VA Connecticut employees and contract staff. 1.4 AUTHORITY: This procurement is being conducted under Federal Acquisition Regulation (FAR) Part 8, Required Sources of Supplies and Services under GSA Schedule. The resultant contract is non-exclusive and shall not prohibit VA or Contractor from entering into agreement(s) with other health care providers or purchasers of health care services. 1.5 PURPOSE: The intent of this procurement is to provide interim OEC 9900 c-arm with the vascular package fluoro lease to provide continuous uninterrupted c-arm imaging preformed in the Operating Room. Contractor s equipment shall be state-of-the art in order to achieve high quality scans utilizing low radiation dosing techniques for VA patient diagnosis. 1.6 CONTRACTOR S FURNISHED EQUIPMENT: Equipment shall be limited to a fully equipped OEC 9900 c-arm with the vascular package Contractor shall submit an equipment specification list, All equipment to be used will be FDA approved imaging equipment placed at a location designated by the COR on site at the West Haven campus. The entire offering of a CT Mobile lease shall meet all local, state, federal, industry, JC, NEC, NFPA, VA, OSHA, and other regulatory standards, internal or external, that the VACTHS is currently accountable for. In addition, the CT Mobile unit shall meet the following specifications: Max width of mobile: 16 feet Max length of mobile: 50 feet Mobile unit shall be compatible with the following main electrical power specifications: 480V, 150A 3 phase, 125KVA, fused at 150, 4 pole 5 wire service in place with a Russelstoll outlet consisting of 4 #3/0 & 1 #6g, Maximum allowable line voltage variation is +/- 10 percent. Phase balance + 2% maximum, as per the OEM Site Guide. (Power needed is: 380, 400, 420, 440, 460 or 480 VAC, 50/60 Hz, 3-phase) 1.7 SYSTEM CAPABILITY REQUIREMENTS: The Contractor shall provide a OEC 9900 c-arm with the vascular package which shall allow the personnel to perform a wide range of exams to include vascular and orthopedic procedures. 1.8 SYSTEM NETWORKING INTERFACES: to be provided at no additional cost to VACTHS. Scanner and all associated equipment - Both hardware and software, which shall have ability to send Digital Imaging and Communications in Medicine (DICOM) images to VACTHS PACS: System shall be able to send to multiple DICOM destinations System shall operate on Windows 10 operating system Shall act as a Service Class Provider (SCP) for third party workstations to pull DICOM The mobile unit shall be equipped with a DVD disk archival system however VA will be responsible for DVD Discs. The patient data and optical disk shall be the property of the VACTHS and remain with VACTHS at the end of the contract term. The mobile unit shall be equipped with DVD-R burning capabilities as a backup, these backups shall be in DICOM format. Shall be compatible with DICOM Modality Worklist C-Find (MWL) to query exams The A&A requirements do not apply, and that a Security Accreditation Package is not required. The computer hard drive will be returned to the VA at the conclusion of this rental agreement. 1.9 EQUIPMENT SPECIFICATIONS: The following minimum performance characteristics of the equipment are required: Brand name OEC is required in order to avoid the need to train staff that is already familiar with the use of this brand of c-arm, currently in use at the VACTHCS. Connectivity to PACS is required as well as all capabilities in Section 1.8 in the above document. Equipment provided shall also include the following: DICOM [connectivity / functionality between VABHS CareStream PACS] DVD disk archival system Contractor shall be required to make whatever adaptations are necessary so that the Contractor s equipment is compatible with the VA furnished services defined herein. The Mobile c-arm shall provide images with consistently high technical diagnostic quality which meet the standard of care. Meet all federal, state, and local fire and safety requirements. Telecommunications: The mobile unit shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network cable. The Government will provide the connection required for the transmission of images, data, and voice - (PACS interface contact person shall be provided to the Contractor during the post-award orientation). 1.11 ADDITIONAL REQUIREMENTS/MOBILE CT UNIT: Contractor shall provide a OEC 9900 c-arm with the vascular package that meets the following physical requirements: Has been approved by the FDA and meets or exceeds minimal standards for the type of equipment being provided as defined herein. 1.12 VA PROVIDED UTILITIES/SERVICES: VACTHS SHALL PROVIDE THE FOLLOWING UTILITIES/SERVICES (IF NECESSARY) FOR OPERATION OF THE CT MOBILE UNIT: Maintenance of the site which meets the requirements for the system. Provision of a Radiologist to oversee procedures, to protocol studies. VA Staff to respond medical emergencies. Provision of medical staff, when required, for procedures. Transportation of patients to/from their medical ward to the waiting area assigned to the service. Provision of medical supplies necessary to perform the procedure. Provision of standard protocols for technical staff and availability of radiologist to confer with regarding protocols. 1.13 EQUIPMENT MAINTENANCE/REPAIRS: Equipment provided shall always be in good working order in order to provide high quality scans required under this solicitation and any resulting contract. Contractor shall be completely responsible for the preventive maintenance, emergency and general repairs, replacement of any defective parts/components, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the C-arm unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer s recommendations. If the equipment should fail during normal working hours, emergency repairs shall be performed on-site by the Contractor s qualified service engineers within a four-hour response time in order to reduce equipment downtime. Contract price shall be reduced by pro-rated amount in the event that the contractor is unable to meet the response times stated herein or as mutually agreed upon with the COR based upon patient scheduling. Notwithstanding, if it is determined that the equipment cannot be repaired on site within an agreed upon period of time, the contractor agrees to replace the Mobile Unit within forty-eight (48) hours of equipment failure. Contract price will be adjusted for any days in which the equipment cannot be used. All required software updates/maintenance (non-emergent) performed by the . 1.14 PARTS: The Contractor shall furnish and replace parts to meet times specified in this agreement. The Contractor shall maintain 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 parts required. The Contractor shall use new or rebuilt parts. All parts shall be of current manufacture 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 piece of equipment shall not be installed without specific approval by the CO or the COR. Contractor s equipment shall be compatible with the VA existing equipment and/or systems in order to provide an interface between the OEC 9900 c-arm with the vascular package and the VA firewall. VA personnel will be assigned to the successful Contractor during the post award orientation to establish network connectivity from the trailer through the VACTHS firewall. The Contractor and OIT official will discuss firewall security and patient data purging procedures from the Contractor s computer hard drives on the trailer unit. The Contractor shall comply with firewall security and patient data purging procedures determined to be applicable by the VA OIT official. All hard drives and removal media that store sensitive patient information will be turned into the VA at the conclusion of the contract period. 1.15 RECORDS AND CONFIDENTIALITY Records created by the Contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal laws and regulations. Whenever possible, records and reports will be made available in digital form. The contractor shall provide VACTHS with the hard-drive system at the conclusion of the contract period. This shall be signed off by a VA Connecticut s Information Security Officer (ISO) and Clinical Engineering (CE) services. The treatment and administrative records created by, or provided to the Contractor under this award, shall be covered by the VA system of records entitled Patient Medical Records- VA (24VA136). In responding to VA Patient requests that copies of their patient records be released to a third party, the Contractor shall refer the VA patient/family to the Release of Information Act (ROI), located within the VA Business office for response. 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. 1.16 TORT CLAIMS The Federal Tort Claims Act does not cover the Contractor and/or its employees. When the group or its employees has been identified as a provider in a tort claim, the Group or Group Employee is responsible for notifying their own legal counsel and/or insurance carrier. Any subsequent settlement or judgment arising from a group or Group employee s act or omission under this agreement is the responsibility of the Group, Group employee and/or insurance carrier unless such act or omission was at the direction of the VA clinical staff member or other VA employee. 1.17 QUALITY CONTROL All studies shall conform to VA protocol established by VA Radiologists prior to any examination being performed. Studies will be performed according to VACTHS protocols. VA estimates 3-5 CT exams to be completed daily. 1.18 INVOICES As full and complete compensation for the c-arm lease, the VA agrees to make payment on a timely basis during the lease period upon receipt of properly prepared invoices submitted by the Contractor as outlined. VA agrees to pay the rates specified by the delivery order award and any rate otherwise agreed mutually upon through modification of the award. Rates are inclusive of all medical supplies, technical fees, facility fees, and interpretative charges for the term of this agreement. Payment shall be made by electronic transfer of funds. All payments will be made monthly in arrears, after receipt of a properly executed invoice. Contractor shall submit an itemized monthly statement. All invoices shall contain the following information: Contract Number Obligation Number Type of service provided (by line item as shown in the schedule of supplies/services) Quantity of each line item Cost per type of service provided Date service provided Invoices shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests contained included in the RFQ and award document. Payment from the VA for services provided under this agreement shall be considered payment in full. The Contractor, unless specifically authorized by the VA, shall not pursue any further collection activities from any other source.