Under Statutory Authority 41 U.S.C. 1901 the White River Junction VA Health Care System intends to negotiate a sole source contract with INSIGHT HEALTH CORP. to provide dosimetry meters and radiation monitoring service. INSIGHT HEALTH CORP. is the sole provider, capable of fulfilling the specific requirement as needed at the WRJ VAMC. This notice of intent if not a request for competitive quotes. This acquisition is conducted under the authority of 41 U.S.C. 1901 Simplified acquisition procedures as implemented in FAR 13.106-3(b)(3)(i), only one responsible source and no other supplies or services will satisfy agency requirements. This will be a firm fixed price contract for a base and four one-year options. The North American Industry Classification System Code (NAICS) is 621512 with a business size standard of $16.5 million. No solicitation documents are available and telephone requests will not be accepted. However, any firm that believes it can meet these requirements may give written notification to the Contracting Officer by 1:00 PM EST, March 8, 2023. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. This evidence shall include a letter from the Original Equipment Manufacturer (OEM) stating vendor is an authorized distributor per clause 852.212-72(c). Information must be sent to the Contracting Specialist, Edward Sullivan,
[email protected]. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. White River Junction, VA Medical Center Radiology Service Statement of Work Mobile PET/CT Scanner Provide the following service in accordance with the requirements of the contract: Health Care Resources in accordance with Public law 104-262 and 38 USC 8153 to be furnished by the contractor at the Department of Veterans Affairs, White River Junction VA Medical Center, 215 N. Main St., White River Junction, VT, 05009. A purchase order will be issued to the responsive, responsible contractor offering the best value for the total time frame of the contract. 1. Services: Contractor shall provide all labor, materials, equipment, maintenance and repair of all Contractor furnished equipment (including the mobile trailer unit), specialized staff, training, required supplies, and medications/drugs to perform Positron Emission Tomography / Computerized Tomography (PET/CT) for the Department of Veterans Affairs, White River Junction VA Medical Center, 215 N. Main St., White River Junction, VT, 05009. Contractor shall be responsible to maintain all of the equipment in good working order at all times and shall reimburse the site for lost time, which may result from defective workmanship or equipment failure. Services shall be performed as listed in the Schedule- supplies and Service/Price /Cost. Due to the sensitive nature of PET/CT services, all items within this statement of work shall be provided by employees of the bidder. Subcontracting is prohibited. 2. Supplies: Contractor shall solely be responsible for the procurement, receipt, dispensing, administration and safekeeping of all supplies and medications/drugs required in the performance of the services defined herein. These supplies include but are not limited to radioisotopes to be handled in accordance with contractor's licensing, state and NRC regulations. Contractor shall also be responsible for the waste management and proper disposal of all radioactive waste materials off the White River Junction VA Medical Center premises. The cost for the disposal and materials furnished under this contract must be included in the contract. 3. Authority: This procurement is being conducted under Federal Acquisition Regulation (FAR), acquisition of commercial items and contracting by Negotiation for procurement of enhanced Health Care resources in accordance with Public law 104-262 and 38 USC 8153. The resultant contract is non-exclusive and shall not prohibit White River Junction VAMC or contractor from entering into agreement(s) with other health care providers or purchase of health care services. 4. Term of Contract: Exercising option year 1 of current contract. This contract is subject to the availability of White River Junction VA Medical Center funds. 5. Purpose: The intent of contracting a mobile PET/CT scanner for the White River Junction VA Medical Center is to provide a cost effective solution that allows greater control over image quality, improve availability and convenience to our patients. 6. Contractor's Furnished Equipment: Equipment shall include, but not be limited to, a contractor furnished fully equipped PET/CT Mobile trailer where studies will be performed on a Philips 16 slice or better PET/CT scanner, manufactured after 2010, and a review station and fusion software to be placed in the White River Junction Medical Center Nuclear Medicine Department or other appropriate site. Contractor shall submit detailed specifications on the equipment. Scanner specifications will include year, manufacturer, model number, and make of all pertinent information. All equipment used will be FDA approved imaging equipment. The entire offering of a PET/CT mobile Trailer service shall meet all local, state, federal, industry, JCAHO, NEC, NFPA, VA, OSHA and other regulatory standards, internal and external, for which the White River Junction VAMC is currently accountable and will be kept current with all federal and state regulations. The contractor's personnel will abide by all policies of the site of service to include but not limited to: radiation and patient safety policies. All exams will be reviewed for appropriateness and protocoled by a VA staff radiologist prior to the start of scanning. 7. System Capability Requirements: Contractor shall provide an on-site Mobile PET/CT system that is a full body PET/CT scanner system in accordance with the terms and conditions of this contract. The unit shall have the ability to perform a wide range of exams as listed below. a. Oncology related PET/CT exams b. Imaging of cardiac metabolism with F- 18 FDG c. Brain imaging with F- 18 FDG 8. Mobile Unit Capabilities: To be provided at no additional cost to White River Junction VAMC: a. Hardware and software to permit interpretation and transmission of images b. A hot lab to receive and store radioisotopes and radioactive waste. c. Ability to create, store and export DICOM, JPEG and MPEG file formats. d. DICOM 3.0 network capability for export of images to Contractor supplied fusion workstation within White River Junction VAMC and or another VISN 1 VA Medical Center. Transport of images will be over VA supplied network infrastructure. e The mobile shall be equipped with a CD-R/DVD burner for a backup to transfer data. f. The mobile shall be equipped with an image analysis station for image registration and quality assurance g. The mobile unit shall be equipped with a MedRad IV contrast injector which is programmable for pressure injections. The injector should have the following capabilities 1. Scan delay 2. Multiphase option 3. Protocol storing 4. Pause hold functionality 5. Weight based contrast dosing h. The mobile PET/CT unit shall interface to an access ramp which will provide a barrier to outside weather conditions. As part of the bid submission process, the vendor will supply drawings and specifications unique to the trailer which is to provide services under this contract. This is to evaluate existing mobile pad suitability. i. The contractor's trailer shall provide the space sufficient and designed for injections, an area for a quiet room with minimum possible external stimuli such as noise and light during the period of the radiopharmaceutical uptake. k. The contractor's trailer shall provide the space sufficient and the appropriate equipment for monitoring of sedated patients and performing CPR if necessary. 9. Mobile Unit Accessories: Accessory equipment that shall be provided by the contractor: a. Handicap accessibility. b. Intercom system between the control room and the scanning room. 10. Mobile Unit Equipment Specifications: The following minimum performance characteristics of the equipment are required: a. Contractor shall provide coach specific requirements for access, docking pad and covered enclosure with the solicitation. Contractor or designee will be required to perform a site visit in advance of contract award to consult with VA supplied engineer to verify improvements required to allow trailer docking. b. The PET/CT shall provide images with consistently high technical quality to be assessed by VA employed experts. Poor image quality will be considered non-performance under this contract and must be remedied within 10 days of notification or incur default.           c. The PET must be capable of acquiring images in multiple modes including but not limited to limited body part scans and whole body scans.   d. The PET/CT will have a PET detector crystal specifically made for PET imaging LSO or LYSO or digital detector is required. e. Time of flight imaging capabilities will be considered a plus           f. The CT scanner unit shall have at minimum: 1) A minimum of a 16 slice detector and be capable of acquiring the transmission image within one breath.                        2) Capable of acquiring data for anatomic localization and attenuation correction.                       3) Attenuation correction algorithm designed to use non contrast CT data. 4) Attenuation correction algorithm designed to use CT data with intravenous contrast enhancement. 5) Attenuation correction algorithm designed to use CT data with oral contrast enhancement with positive contrast (iodinated contrast). 6) Attenuation correction algorithm designed to use CT data with oral contrast enhancement with negative contrast (water). 7) CT will be optimized for low dose procedures to include such features as: automated dose modulation, iterative reconstruction, and DICOM Structured Dose Reporting.            g. Provision of one PET/CT review station to include: 1) Fusion software compatible with the Philips PET/CT system provided and connected to the mobile system via VA provided network infrastructure over V-LAN. The review station shall have the capacity to handle the computational load of 3 dimensional datasets and sufficient storage to keep images for a minimum of one year or at the contract conclusion. 2) The vendor will provide hardware and software maintenance during the term of this contract. The review station will be provided with software and hardware license, capable of producing PET and CT image data for input into VA PACS.                       3) The review station shall have two large color monitors of diagnostic quality. 4) The review station shall have computers with high processing performance and large memory capacity to achieve real-time interactive navigation without compromising the native resolution of CT images (spatial resolution and dynamic range) or the scale of PET data to match the CT resolution. 5) The review station shall have image fusion capability as well as whole body display. 6) The review station shall have software tools that allow interpreting physicians to easily and efficiently navigate between the two modalities. 7) The review station shall have software tools that are capable of providing three (3) orthogonal planes of the CT images alone, the PET images alone and the superimposed PET/CT images and an additional set of non-corrected PET images and generating suv and Hounsfield measurements, size volume and angle measurements             h. The mobile PET/CT unit shall be ready for use regardless of outside environmental conditions. 1) The mobile PET/CT unit shall maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for patient comfort.                        2) The mobile PET/CT unit will meet all federal, state, fire and safety requirements. i. Telecommunications: The mobile unit shall be equipped with outlet jacks connections capable of transmitting data and voice through Government provided category five (5) and dual power phone cable. The Government will provide connections required for the transmission of images, data, and voice.             j. The mobile unit shall support DICOM Modality Worklist (DMWL), for future use and shall be able to export DICOM images to multiple destinations.            k. The system must be approved by the FDA and meets or exceeds minimal standards for the type of equipment provided as defined herein.            l. White River Junction VAMC will provide:                       1) Electricity                      2) Telephone lines                      3) Data port                      4) Housekeeping--- White River Junction VAMC will be responsible for the area within the facility prior to the entrance of the mobile trailer. 5) Emergency support equipment (Crash cart) 6) Expendable medical supplies as related to the standard provision of PET/CT services 11. EQUIPMENT MAINTENANCE/REPAIRS: Equipment provided shall be in good working order at all times 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, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the PET/CT mobile 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, qualified service engineers will perform emergency repairs on-site in order to reduce equipment downtime. Quality Control and monitoring will be performed by the contractor provided staff daily or at the regular intervals as specified by the manufacturer and in accordance with standard practices established by all governing agencies. Any and all discrepancies will be reported to the VA prior to the start of any patient procedure/exam. Documentation will be provided to the VA and kept in the Nuclear Medicine Department. The VA maintains the right to monitor compliance with all required QC/M as well as compliance with all appropriate rules and regulations as applicable. Contractor agrees to reimburse White River Junction VAMC for costs over and above the contracted cost associated with obtaining PET/CT exams though other sources which are necessary for appointments cancelled or postponed as a result of equipment, staffing and/or radiopharmaceutical failure. Exams canceled or postponed due to failure of services provided by the contractor must be rescheduled and performed by the contractor at the original imaging site within 7 days of the initial appointment during the normal operating hours of the PET/CT clinic services. If it is not possible to reschedule the patient within 7 days and White River Junction VAMC must make alternate arrangement to have the patient sent to another local facility for the tests, the Contractor shall bear the costs associated with such re-procurement over the contracted examination price. White River Junction will provide the Contractor with an itemized list of costs as a result of any service failure and cost will be deducted from the Contractor s invoice for the period involved. Contractor shall be responsible for the overall housekeeping of the unit including but not limited to removal and proper disposal of all debris on a daily basis or as often as necessary to maintain a sanitized and neat environment in accordance with the Conformance Standards. Contractor shall be responsible for all equipment while on White River Junction premises. At least one of Contractor s personnel must be present during working hours while the equipment is located on the White River Junction campus. White River Junction VAMC will not be held responsible for any loss or damage to the Contractor s property, which may be vandalized or damaged, including the mobile trailer while on site. Contractor shall maintain property insurance on all equipment throughout the duration of the contract and the successful Contractor shall provide proof of insurance as required herein. 12. SITE PREPARATION: White River Junction VAMC in this contract will provide a mobile docking pad meeting the specifications specified by the Contractor. Site specifications including dimensions, weight restrictions and utility connections must be specified by the contractor when presenting pricing information. Pre-award site visits will be provided by potential Contractor to advise each medical center on changes required to make their site acceptable for mobile services. 13. CONTRACTOR S QUALIFICATIONS: A proposal will be considered only from offerors who are regularly established in the business called for, who are financially responsible and have the necessary equipment and personnel to furnish service in the volume required for all items under this solicitation. The successful Contractor shall meet all Federal, State and Local codes and requirements for the operation of this service and equipment provided. Employees authorized by the Contractor to perform services under this specification and any resulting contract, (including all PET/CT Scanning Technologists) shall be licensed and/or registered in a State, Territory or Commonwealth of the United States or the District of Columbia and meet the Nuclear Medicine Technologist professional qualification criteria of White River Junction VAMC. Contractor shall provide with his or her signed proposal, a description of all personnel, who will be providing services under this RFP. These personnel shall include, but not be limited to the technologists, support and driver staff who may visit a medical center as part of their duties under this contract or have access to confidential personal patient information. . In addition, the PET/CT scanning technologists shall be certified Nuclear Medicine Technologists (ARRT and/or NMTCB) as defined herein. In addition if performing diagnostic CT exams the technologist will have the appropriate competencies and certifications. The Contractor shall provide documentation of training and competency of all proposed technologists in all of the following areas: 1) PET imaging. 2) Operation of a PET/CT scanner. CT certification 3) Intravenous administration of radioisotopes. 4) Administration of both I.V. and oral contrast. In the event that additional technologists are required to increase services under this contract, the Contractor shall be requested to provide a written description of those personnel to the Contracting Officer for approval and security clearance (background investigation) prior to the commencement of any additional services. The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; including knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation; and listing of relevant continuing education for the last two (2) years. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the White River Junction COTR, or upon request, for each Contractor employee working on the contract. Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). Contractor s technologists will be required to type patient information into the PET/CT computer ensuring that all images are identified with the correct patient information to include: full name, social security number, date/accession number and modality type. Contractor s assigned personnel must be computer literate in the type of software and/or hardware associate with their duties. 14. CONTRACTOR S STAFF: Contractor shall provide all required specialized medical PET/CT Technologist(s) and any qualified support staff (as patient volume requires) necessary to provide services for the White River Junction VAMC patients. It is anticipated that equipment and staff will be required up to a ten (10) hour day, one (1) day per week. The personnel will perform a function that requires them to access VA system or VA sensitive information. PET/CT Mobile Unit Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed. Contractor technical employees shall be CPR BLS certified and are authorized to initiate this life-saving act if necessary. 15. CERTIFICATIONS/LICENSING DOCUMENTS: PET/CT SCANNING TECHNOLOGIST The vendor should submit with their offer the following documents (as applicable): Copy of all of personnel s current licenses (Certification / Registration) A list of the experience of the proposed contract employees PET/CT competency Check List(s) CPR BLS certificate Any other requested reports/documentation as defined in the Statement of Work (SOW) and Specifications. A. GENERAL REQUIREMENTS: 1. SCHEDULE: The successful Contractor will perform services up to ten hours per day on a weekday to be established independently with the medical center. Initially, the medical center will require services one day per week. Government reserves the right to increase the number of days as noted herein. Contractor will be given at least sixty (60) calendar days notice of a site s intention of increasing the number of days per month for which the Contractor will perform services on site. Any additional days added, will be agreed upon between the Contracting Officer (CO), COTR and the successful Contractor. 2. NORMAL HOURS OF OPERATION: Contractor personnel shall be available on site to perform exams on patients for up to ten (10) hours per day on a weekday identified by the schedule, excluding Federal holidays. The first radiopharmaceutical injection will start at 8:00 am and the last patient being injected such that the exam is completed by no later than 6:00 pm. Trailer delivery, setup and daily quality control procedures shall not delay the start of examinations. Contractor and COTR shall mutually agree upon a schedule establishing dates and time for the mobile unit with technicians to be present on station. Hours of operation less than ten must be approved in advance by the site COTR. a) National Holidays: The ten (10) holidays observed by the Federal Government, are New Year's Day, Martin Luther King's Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas or any other day specifically declared by the President of the United States to be a national holiday. b) Off-Duty Hours: Days and hours other than stated above. 3. DAILY ACCESS TO White River Junction VAMC: The contractor will be responsible for contacting the VA Police at the site of service at the time of arrival, in which the contractor will need access to both the building and data port connections for that day s operation. The contractor will also be responsible for contacting the site VA Police at the closing of each workday to ensure that both the building and the data port connections are secured. The location and contact numbers will be provided by the COTR to the contractor at the post award orientation meeting. B. CONTRACTOR S RESPONSIBILITIES: 1. Contractor will be responsible for providing the qualified PET/CT Scanning Technologist(s) to perform services defined herein. 2. Contractor will be responsible for the training of at least one (1) White River Junction Nuclear Medicine Physician on site on the use of the Contractor provided workstation and image analysis software. 3. Contractor will be responsible for the timely delivery of the PET/CT trailer such that the Contractor may facilitate the following start up functions: Prior to the commencement of daily services, the Contractor shall perform whatever tests are necessary so that the mobile trailer and all associated equipment is fully operational, safe and ready for services so that the schedule of patients is maintained at all times. Prior to the commencement of services the Contractor shall ensure that the mobile trailer is properly positioned and docked. Contractor shall also ensure that the normal temperature within the mobile trailer is set and maintained prior to services. Prior to the commencement of daily services the Contractor shall ensure that the mobile trailer is level and set for the safety of patients and the appropriate utilities connected for proper warm up of all on board systems. Contractor shall allow sufficient time for contacting the VA Police when gaining access to White River Junction VAMC site Communications systems will be operational before commencement of services. 4. Daily Quality Control time must not interfere with the regular scheduling of patients for exams. These start up functions must be completed prior to 8:00 am on each day when trailer is scheduled to be on site in time for the first patient s injection. 5. Contractor will be responsible for providing quality review in order to ensure quality diagnostic images at all sites. White River Junction VAMC reserves the right to require corrective action if image quality or other service problems are brought to the attention of the Contractor. 6. Contractor will be responsible for monitoring the number of PET/CT scans performed, by maintaining a daily log. 7. Contractor shall be Joint Commission Accreditation of Healthcare Organizations (JCAHO) certified or shall follow established JCAHO guidelines as they pertain to mobile PET/CT operations, injection control, patient safety and shall follow the guidelines of the Department of Veteran s Affairs (VA) and Occupational Safety Health Administration (OSHA). JCAHO accredited Quality assurance survey reports shall be provided to the Contracting Officer s Technical Representative (COTR) consistent with Joint Commission recommendations 8. SCHEDULING OF PATIENTS/SERVICES: Services shall be scheduled for one day weekly up to ten (10) hours per day. Scheduling conflicts, which cannot be resolved, will be decided by the Contracting Officer. The decision of the Contracting Officer will be final in accordance with the disputes provisions of this contract. (VA will consider alternative schedules if advantageous to the Government). The Contractor shall be required to confirm the scheduled examinations, by contacting the Contracting Officer s Technical Representative (COTR) or designee two (2) working days prior to the date of services. Contractor shall establish a firm cut off time for next days add on exams that will guarantee delivery of the 18-FDG doses if required. Procedures will be established and will be mutually agreed upon between the COTR, CO and the successful Contractor during the post-award orientation. The Contractor, based on the knowledge of their PET/CT system and of PET/CT technology shall determine a maximum number of patients that may be imaged within a day where the first patient is injected at 8:00 a.m. and the last patient is completed by 6:00 p.m. In accordance with the above, the Contractor shall submit with his/her signed proposal, a proposed schedule based upon the level of expertise of the Contractor s personnel. Contractor shall take into consideration all components necessary in order to maximize on the quantity of scans anticipated to be performed in the ten (10) hour period per day. 9. CANCELLATIONS/NO CHARGE SERVICES: The Contractor will not charge White River Junction for services or supplies (including unused 18-FDG doses) or other radioactive agents when the PET/CT scanner is inoperable due to equipment malfunction or staff shortage occurs. 10. RADIOACTIVE MATERIALS HANDLING REQUIREMENTS: The Contractor will procure all radioactive materials (including but not limited to 18F-FDG) under their NRC (Nuclear Regulatory Commission) agreement/state license and shall be ordered directly by the Contractor. Copy of the Contractor s NRC license or Reciprocity Agreement shall be provided with the signed proposal as further defined in 52.212-2. Contractor shall be solely responsible for the receipt, administration, safekeeping, waste management and proper disposal of all radioactive materials required in the performance of the services by the Contractor. Contractor shall be responsible to ensure compliance with all regulations on the handling of the above as may be required under this agreement. The Contractor agrees that if any additional medications/drugs approved by the FDA are required during the performance of services, that White River Junction would have the right to purchase such drugs (either from the Contractor or from another source) and have these medications delivered directly to the Contractor s trailer during the duration of this contract. The Contractor will accept the drugs in behalf White River Junction under the Contractor s current NRC license at no additional cost to the government. Regardless of the source of purchase, if radioactive, the material will be received at the Contractor s property, which is the PET/CT trailer, by qualified and authorized Contractor personnel. Radioactive waste management will be provided on the Contractor s property, which is the PET/CT trailer, by Contractor personnel. VA facilities will not be used for disposal of any materials from the trailer. Unless otherwise defined herein, radioactive administration to patients will be provided on the Contractor s property, which is the PET/CT trailer. Radioactive decontamination of the Contractor s property due to any cause will be provided by Contractor personnel. Storage of such contaminated items will be provided by the Contractor. All record keeping requirements regarding the receipt, use, storage and disposition of radioactive material is the responsibility of the Contractor under their appropriate license. An audit of the PET service will be accomplished at least quarterly by the site Radiation Safety Officer. This audit will be scheduled with the vendor at least two weeks in advance and will take no more than 60 minutes per period. The Contractor agrees to ensure that compliance/acceptance testing of the PET/CT equipment is performed on at least an annual basis or if major components of the machine are serviced or replaced. The compliance/acceptance tests will be done in accordance with nationally recognized standards (NCRP, AAPM) and JCAHO requirements. The Contractor is responsible for ensuring the compliance testing of the PET/CT machine will be performed by a qualified medical physicist. A qualified medical physicist as defined, is an individual who is certified by the American Board of Radiology, American Board of Health Physics, or American Board of Medical Physics in the appropriate disciplines of radiologic physics, and maintain state certification as a Health Physicist. The Contractor is responsible for maintaining all appropriate records and documentation relevant to compliance and performance of the equipment. 11. REMOVAL OF CONTRACTOR S EQUIPMENT: Contractor will be responsible for the timely removal of the PET/CT trailer from White River Junction premises as agreed upon with the COTR not to exceed a 24 hour period after completion of the last procedure is performed and will also be responsible for the following daily exit functions: Ensure that the day s entire exam data is completely transferred to the vendor provided advanced analysis workstation inside the medical center. All patient exam data is purged from Contractor s computer systems once it is verified that exams are viewable on the vendor provided advanced analysis workstation. At the termination of the contract, the VA site will be allowed 30 days to overwrite the hard drive of the workstation removing all information of any kind including software and operating system before the workstation is removed by the vendor. VA information retained by the PET/CT scanner itself and other Contractor equipment will be returned to the VA at the end of the contract and when no longer required for regulatory purposes. The security of information retained by the PET/CT scanner and other Contractor equipment both during the contract period and post contract period will be the responsibility of the vendor. All connections from the trailer to property are properly disconnected. Any temporary site preparations are removed upon completion of services on a daily basis. C. CONTRACTOR STAFF QUALIFICATIONS/RESPONSIBILITIES Contractor will provide the services of an experienced PET/CT Scanning Technologist(s) to operate the mobile trailer. The PET/CT technologist(s) shall be fully trained / qualified according to the qualification standards that have been previously defined in this document. The technologist must also be basic life support CPR- certified. The qualifications of such personnel shall also be subject to review and approval by the facility Chief of Staff and Chief of Radiology. The technologist shall be trained and qualified to perform venipuncture, assess IV patency, and administer the radioisotope, according to procedures and protocols. The PET/CT scanning technologist shall be trained and qualified to screen patients using a facility questionnaire for potential contraindications to PET/CT imaging, based on facility imaging procedure/protocols. PET/CT Scanning Technologist shall maintain a log of all VA patients receiving PET/CT scans. Such logs shall be available for inspection by duly authorized representatives of the facility upon reasonable notice to the mobile unit s personnel. Inspection shall be during normal working hours of the mobile unit while at the facility. PET/CT Scanning Technologist shall ensure that, when applicable, patient informed consent (according to applicable VHA policies/procedures) is obtained and presented prior to performing examinations. PET/CT Scanning Technologist shall be responsible to screen patients prior to performing PET/CT exams to verify the patient s identification, pregnancy status, breast-feeding status, and confirm the procedure to be performed prior to commencement of any services. Disqualification of a patient from the exam must be documented and provided to facility Nuclear Medicine staff before the patient leaves the PET/CT Trailer during each visit. Any side effects that may develop from injection of the radiopharmaceutical and/or iodinated contrast agent or from patient preparation must be reported to the designated nuclear medicine physician as quickly as possible considering the clinical situation while the patient is in the trailer. The PET/CT technologist is responsible for the initial assessment and identification of medical emergencies and initiating the emergency response procedure for patients in their care. The training for this will be a part of initial facility orientation PET/CT Scanning Technologist shall ensure that all PET/CT exams shall be acquired and processed per procedures and protocols provided by the facility Nuclear Medicine physicians. Raw and processed data remain the property of the government. PET/CT Scanning Technologist shall present (electronically transmit and notify) each completed PET/CT examination to the designated facility Nuclear Medicine physician to review for diagnostic quality before the patient is discharged back to the medical center, this will be determined by the Nuclear medicine physician. VA Nuclear Medicine physicians will perform interpretations of the examination(s). Unsatisfactory/non-diagnostic PET/CT examinations shall be re-performed at the discretion of designated Nuclear Medicine Physician. The PET images shall be reconstructed by the PET/CT technologist with and without attenuation correction and be available at the time of interpretation. Additional requirements for Contractor personnel and Contractor operation: Contractor shall provide White River Junction VAMC seven (7) day per week telephone access to the mobile PET/CT company used in performance of this contract. Name: _____________________________, Telephone No. _______________________________, Services provided by the Contractor shall be performed within the policies, procedures and regulations of White River Junction. Contractor shall meet the safety requirements of posting Radiation hazardous signs around the mobile unit and make certain the electrical power cable is under a metal cover, if it crosses the sidewalk. Neither the Contractor nor the contract personnel shall in any way undertake the practice of medicine, render medical opinions or services other than those services required to support the well-being of the patient, or in any way with the patient other than to provide all ancillary and technical services required for the operation of the unit. D. CONTRACTOR FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT: 1. The Contractor s Vehicle shall be parked and leveled no more than 12 from docking pad ramp. Contractor shall be responsible for leveling of the vehicle at location designed by White River Junction VAMC. 2. Contractor shall contact the COTR to make the necessary arrangements for a site visit where the actual location where the mobile trailer will be located so that precise measurements etc. can be taken by the Contractor who shall be responsible to confirm compatibility of the docking pad and connections as noted herein. Any additional costs as a result of the Contractor s failure to confirm the above shall be the responsibility of the successful Contractor. 3. Contractor shall be held responsible for any damages, which may be done to the property during delivery, hookup and/or removal of equipment at the site. Any damages caused by the Contractor shall be repaired/performed at the Contractor s expense to the satisfaction of the facility Chief of Engineering. 4. Proper installation/staging of the Contractor s furnished equipment including the mobile trailer must be completed in accordance with industry standards, all OSHA regulations and applicable manufacturer s recommendations. The above must be completed prior to commencement of services. Dates and time for completion of the above shall be mutually agreed upon between White River Junction VAMC and the Contractor. E. GOVERNMENT FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT: 1. The VA facility shall provide all patient services, with exception of the services provided by the Contractor s PET/CT Scan Technologist including the following: (a)Retain full medical responsibility for its patients. Contractor shall be responsible for patient upon pickup at the White River Junction designated waiting area, while on the Mobile unit and during the entire scanning procedure until patient is returned to the designated waiting area. (b) Approval and scheduling of patients for PET/CT exams will be provided by the facility where the services are provided. The facility will fax a patient list of exams and exam times to the Contractor in a fashion that is timely and convenient to the Contractor. The Contractor will follow up with phone verification of the patient list. (c) Pre-test screening will be provided by the facility. These patients will be made available to the Contractor at the specified appointment injection time. (d) The facility will be responsible for transporting patients to and from the facility furnished waiting area. Contractor shall be responsible to pick up and transport the patient to the Contractor furnished Mobile Trailer. Upon completion of services, the Contractor shall return patient to the designated waiting area within the Medical Center. (e) The facility shall be responsible for scheduling and handling patient issues that would prevent the patient from being available for the scheduled injection. This will be communicated by the facility to the Contractor. (f )The Contractor providing PET/CT technologists will observe sedated patients on the Contractor s trailer. The VA facility will identify patients, provide and administer any sedation that patients may require prior to the scans provided by the Contractor. Sedated patients will be identified and will be given special care by the Contractor, including documentation of vital signs, during and at the completion of any procedures. The above must be coordinated in advance with designated COTR or designated alternate. It will be the facilities responsibility to determine if sedations will be conducted in the mobile scanner area. (g) The VA facility shall ensure each patient arriving for the PET/CT scans has physician orders to receive services and such other forms or information as required. Contractor is required to identify patients using two unique identifiers prior to venipuncture or injection of contrast or radiopharmaceutical as required by site policy. (h )The VA facility will designate in writing one or more qualified physicians who will review orders for appropriateness, interpret PET/CT reports and take such other steps as may be medically necessary. 2. White River Junction VAMC will provide the following services, supplies and facilities: (a) All medical supplies, facilities, personnel and physicians required to provide patients with such emergency medical care as may be required, including oxygen, aspirator and defibrillator when deemed necessary. (b) The successful Contactor shall provide during the Post Award Orientation a reasonable list of incidental supplies which may be necessary. (Excluding those which are defined as the Contractor s responsibility). F. COMMENCEMENT OF SERVICES: Commencement of service date is to be coordinated with the COTR. Unit must be ready for patient services no later than 45 days after contract award unless otherwise agreed to in writing with the Contracting Officer. G. PLACE OF INSPECTION AND ACCEPTANCE: 1. Delivery location of PET/CT Mobile Trailer site shall be coordinated with the COTR. 2. Inspection and acceptance of all work performance, reports and other deliverables under this contract shall be performed at the place of delivery. 3. The FAR clauses incorporated by reference are applicable to all supplies/services/equipment under this contract. H. SCOPE OF INSPECTION: 1. Deliverables will be inspected for content, completeness, and accuracy and conformance to contract requirements by the COTR or his/her designee. Inspection will include validation of information or software through the use of automated tools and/or testing of the deliverables, as specified in the contract order. The scope and nature of this testing must be negotiated prior to the contract award and will be sufficiently comprehensive to ensure the completeness, quality and adequacy of all deliverables. 2. Reports, documents and narrative type deliverables will only be accepted when all discrepancies, errors or other deficiencies identified in writing by the government have been corrected. 3. Maintenance logs will be available upon request. I. NON-CONFORMING PRODUCTS OR SERVICES: Non conforming products or services will be rejected. Unless otherwise agreed by the parties, deficiencies will be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor will immediately notify the COTR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days. J. EMERGENCY REPAIRS: Emergency service: Contractor shall provide, at no cost to White River Junction VAMC, all emergency service to include all required personnel, parts and labor, and preventive maintenance/repairs of positron emission tomography (PET/CT) structure and equipment to maintain a safe environment as recommended by the original equipment manufacturer (OEM) recommendations/specifications in accordance with the agreed upon schedule with the COTR. Response Time: In the event of an equipment failure during normal working hours while in the performance of the Contractor s services, the Contractor shall notify the COTR or designee immediately after discovery of equipment failure while on site. All emergency repairs are the responsibility of the contractor. The COTR shall determine if appointments previously scheduled should be cancelled and rescheduled as a result of the equipment failure. In the event that the equipment fails and the failed equipment is un-repairable, the Contractor must obtain an alternate unit which will be available on the next scheduled day and which meets all of the requirements of the resulting contract to ensure that schedule services will be performed as agreed upon under this agreement. K. DOCUMENTATION/REPORTS: 1. The Contractor will provide to the COTR equipment and maintenance reports if requested by the COTR during the duration of the contact. The Contractor will also provide system pre-check and associated documentation at the time the unit is set up at the site where services are to be performed. This is to ensure safety of equipment utilized by White River Junction personnel/beneficiaries. 2. The Contractor will permit on site inspection by personnel selected without prior notice to insure the Contractor s equipment is operated in accordance with appropriate safety guidelines and/or regulations as applicable. 3. Additional Reports/Documentation required by the successful Contractor prior to commencement of services of both PET/CT Technologist and PM/Repair services, unless otherwise stated. This VISN may require specialized documentation to satisfy the requirements of local state and federal government agencies, and independent consultants such as the Joint Commission on Accreditation for Hospitals, as well as for services rendered verification for payment of monthly statement. At a minimum, the following information will be provided to the Contracting Officer: (a) Certificate of Insurance not limited to but, includes: Professional Liability, Worker s Compensation, liability and property insurance of Contractor s furnished equipment which shall be submitted to the Contracting Officer within ten (10) calendar days of receipt of notification of award. It is agreed upon and understood that the White River Junction VAMC will not be held responsible for any damage or vandalism, which may be caused to the Contractor s equipment while on premises. (b) Copy of appropriate Business License submitted with signed proposal. (c) Contractor s employees Certifications/Registrations, Competency Check List and Training Certificates to be submitted with signed proposal as defined herein. (d) Technologists Health examination records of Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test. Copies of records shall be submitted to the Contracting Officer prior to commencement of services. (e) Upon request of the Contracting Officer, Contractor shall provide procurement documentation for receipt and dispensing of radioisotopes. (f) Copies of all required Federal, State and local licenses including specifically the Contractor s current NRC or agreement and state license authorizing the use of radioactive material at temporary job sites. (g) Copy of Hazardous Materials Certificate, DOT F5800.2 at the request of the COTR. (h) Documentation of scanner(s) make, model, and year of manufacture and specifications, plus brand and release number of 3D fusion software for contractor supplied independent interpretation workstation. Documentation to be submitted with signed proposal. (i) A copy of the coach requirements for docking pad will be submitted with signed proposal. (j) Documentation of a proposed schedule included in the submission along with maximum throughput of proposed system(s) will be submitted with signed proposal. (k) Documentation of JCAHO certification (if available) will be submitted with signed proposal. NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE SUBMITTED IN WRITING AND APPROVED BY THE CO BEFORE SERVICE COMMENCEMENT. FAILURE TO OBTAIN THE ABOVE WILL BE PROVIDED AT NO ADDITIONAL COST TO THE GOVERNMENT. L. PROTECTION OF GOVERNMENT PROPERTY: During work execution, the Contractor shall take special care to protect Government property including but not limited to all furniture, walls, baseboards, exterior and other surfaces. Damage resulting from Contractor operations shall be repaired by the Contractor, including painting, refinishing, or replacement (if necessary), at no additional cost to the Government. Contractor shall be responsible to meet all OSHA/Safety requirements in the performance of the work. Installation shall be coordinated between the COTR and the Construction/Renovation Contractor. Contractor shall be held responsible for any injuries and/or damage, which may be caused as a result of the Contractors negligence or failure to adhere to these requirements.