Attach 01 SON.docx

Statement of Work for Medrad Stellant Flex OCS CT Injection System VA Pittsburgh Health Care System-University Drive University Drive C Pittsburgh, PA 15240

1. Background:

1.1. The Medrad Stellant Flex OCS CT Injection system is the current system being used in CT Scanner Room 2 at VA Pittsburgh Radiology Department. For standardization, the Radiology Department is requesting to update the current system in CT Scanner Room 2 and replace the older version in CT Scanner Room 1 with the newest technology from Bayer. By standardizing, it will provide consistency for staff and the same disposables can be used for both scanners.

2. Scope:

2.1. The Medrad Stellant Flex OCS CT Injection System with enables the flexibility of injecting contrast and saline-offering many clinical and workflow advantages, such as: using saline to perform a patency check, reducing image artifacts, and providing brighter arterial imaging in CT.

2.2. The Medrad Stellant Flex OCS CT Injection System is a replacement for an existing current the end-of-life stage CT Contrast Injectors

2.3. The first Medrad Stellant Flex OCS CT Injector will have updated software, the second Medrad Stellant Flex OCS CT Injector will have the current software transferred from the existing installed unit.

2.4. Requirements

2.4.1. Table

Package

Package

2.4.2. Salient Characteristics

2.4.2.1. Designed for complex contrast enhanced CT protocols

2.4.2.2. Creates a tight contrast bolus

2.4.2.3. Enables precisely timed contrast delivery

2.4.2.4. Provides more uniform attenuation of the right and left ventricles

2.4.2.5. Minimizes artifacts by achieving proper attenuation levels

2.4.2.6. Visualize the right coronary arteries and right ventricles in a single study by achieving more uniform attenuation

2.4.2.7. Informatics ready platform – enables interconnectivity between your CT scanner, power injector, PACS, RIS, & speech recognition systems

2.4.2.8. Storage and recall of up to 250 protocols

2.4.2.9. Enhanced protocol manager

2.4.2.10. Snap-on/twist-off syringe design

2.4.2.11. Automatic plunger advance and retract when attaching and detaching syringes

2.4.2.12. Automatic filling and priming

2.4.2.13. Multi-phase programming (and patented hold/pause feature)

2.4.2.14. Integrated saline test inject

2.4.2.15. Programmable pressure limit

2.4.2.16. On-board eGFR and weight-based dosing

2.4.2.17. Injection enabled when head is tilted down

2.4.2.18. Automated data capture

2.4.2.19. Interface with PACS/RIS/SR

2.4.2.20. Export of a DICOM secondary capture to PACS

2.4.3. System Specifications

2.4.3.1. Contrast Delivery

2.4.3.1.1. Referrers rely on prompt, accurate diagnoses to guide therapy and enable improved patient outcomes. Precise contrast delivery is expected for consistency to allow optimal image quality.

2.4.3.1.2. Protocol management and precise contrast delivery

2.4.3.1.3. Perform complex CTA and cardiac CT protocols

2.4.3.1.4. Create a tight contrast bolus

2.4.3.1.5. Enable precisely timed contrast delivery

2.4.3.1.6. Individualize contrast dose with Certegra P3T 2.0

2.4.3.2. Dual syringe utilization benefits

2.4.3.2.1. DualFlow, simultaneous injection of contrast and saline in user-selected ratios can:

2.4.3.2.1.1. Enable better visualization of the right heart due to reduction of streak artifacts

2.4.3.2.1.2. Visualize the right coronary arteries and right ventricles in a single study by achieving more uniform attenuation

2.4.3.3. Workflow

2.4.3.3.1. Enhanced protocol management and injector design that enable efficiency improvements.

2.4.3.3.2. A simple workflow can help to save procedure time, avoid errors

2.4.3.4. Simple to use, automated injection system

2.4.3.4.1. Streamline workflow

2.4.3.4.2. Integrated saline test injection with real-time pressure monitoring

2.4.3.4.3. Snap-on/twist-off syringe design

2.4.3.4.4. Plungers automatically advance and retract when attaching and detaching syringes

2.4.3.4.5. Automatic filling and priming

2.4.3.4.6. Multiphase programming, including hold/pause feature

2.4.3.4.7. Programmable pressure limit

2.4.3.5. Accurate post-study documentation

2.4.3.5.1. Improve reporting accuracy

2.4.3.5.2. Achieve workflow efficiencies

2.4.3.5.3. Enables reduction of errors and information gaps

2.4.3.6. Multi-Patient Syringe System

2.4.3.6.1. Cost efficiency

2.4.3.6.2. Perform multiple studies with a single syringe kit (for up to 12 hours)

2.4.3.6.3. Recessed connections to avoid accidental contamination

2.4.3.6.4. Multi-patient tube for reuse plus single-patient tube that needs to be replaced after each study

2.4.3.6.5. Special check valves that prevent backflow from the patient

2.4.3.7. Scalability

2.4.3.7.1. Certegra P3T 2.0 Software recommending personalized injection protocols

2.4.3.7.2. Personalized patient protocols allow technologists to individualize contrast dose protocols individually at the point of care with ease

2.4.3.7.3. Abdomen studies

2.4.3.7.4. Pulmonary angiography studies

2.4.3.7.5. Cardiac studies

2.4.3.7.6. Certegra Imaging System Interface (ISI) – Scanner connectivity

2.4.3.7.6.1. Certegra ISI 700 (for Philips scanners)

2.4.3.7.6.2. Certegra ISI 800 (for Siemens and Toshiba scanners)

2.4.3.7.6.3. Certegra ISI 900 (for Siemens, Toshiba, Hitachi and General Electric scanners)

2.4.3.7.6.4. Connect.CT sold as Philips SyncRight (for Philips scanners)

2.4.3.7.7. Contrast Dose Management (CDM)

2.4.3.7.7.1. CDM automates documentation of contrast injection at the point of care and throughout the post-procedure workflow.

2.4.3.7.7.2. CDM provides tools to help drive efficiency, reproducible quality and personalized care

2.4.3.7.7.3. Auto-populate contrast injection records transferred to PACS, RIS and Speech Reporting (SR)

2.4.3.7.7.4. Achieve workflow efficiencies

2.4.3.7.7.5. Improve reporting accuracy

2.4.3.7.7.6. Automate documentation

2.4.3.7.7.7. Use data to inform improvement initiatives

2.4.3.7.7.8. Accelerate report turnaround time

2.4.3.7.7.9. Investigate and tie information to outcomes

2.4.3.7.7.10. Less time preparing for the injection and more time to focus on the patient and optimize procedure management

2.4.3.8. Seamless Network Communication with Radimetrics Enterprise Platform for Contrast Dose Management

2.4.3.8.1. Connect with the Radimetrics Enterprise Platform for automated documentation and viewable patient histories to enhance operational consistency

2.4.3.9. Convenience at Point of Care

2.4.3.9.1. On-board eGFR and Weight Based Dosing Calculators, an Injection Pressure Graph and independent Test Inject and KVO functions are convenient features located right on the Injection System

2.4.3.9.2. Accurately capture contrast information at the source and automatically populate workstation data fields with the Barcode Reader

2.4.3.10. Real-time Support

2.4.3.10.1. Connect to VirtualCARE Remote Support for advanced injector system diagnostics, seamless software updates and fast repairs

2.4.3.11. Deliver with Confidence in Quality

2.4.3.11.1. The next generation in MR consumables Bayer stands behind. Designed, tested and warranted as part of the Total MR SMART Injection System

2.4.3.12. Improved Efficiencies

2.4.3.12.1. For Workflow and Automated Fluid Delivery

2.4.3.12.2. Snap-on/twist-off syringe design

2.4.3.12.3. Automatic plunger advance and retract when attaching and detaching syringes

2.4.3.12.4. Automatic filling and priming

2.4.3.12.5. Injection pressure graph

2.4.3.13. Personalized Care

2.4.3.13.1. Through Convenience at Point of Care

2.4.3.13.2. Patient-Centric workflow design

2.4.3.13.3. Modality worklist connectivity

2.4.3.13.4. Protocol storage/retrieval

2.4.3.13.5. On-board eGFR and Weight Based Dosing Calculators

2.4.3.13.6. Injection enabled when head is tilted down

2.4.3.14. Reproducible Quality

2.4.3.14.1. To Enhance Operational Consistency

2.4.3.14.2. Proven company track record of design and performance

2.4.3.14.3. Automated data capture

2.4.3.14.4. Interface with PACS/RIS/SR

2.4.3.14.5. Export DICOM secondary capture to PACS

2.4.4. Mechanical Specifications

2.4.4.1. Dual Injector Head

2.4.4.1.1. Height 15.5 cm (6.1“)

2.4.4.1.2. Width 30.7 cm (12.1“)

2.4.4.1.3. Depth 36.8 cm (14.5“)

2.4.4.1.4. Weight 8.1 kg (17.9 lb.) (without syringe)

2.4.4.2. Base Unit

2.4.4.2.1. Height 29.2 cm (11.5“)

2.4.4.2.2. Width 27.9 cm (11.0“)

2.4.4.2.3. Depth 22.2 cm (8.8“)

2.4.4.2.4. Weight 6.2 kg (13.6 lb.)

2.4.4.3. Certegra Workstation (CWS)

2.4.4.3.1. Height 34.2 cm (13.5“)

2.4.4.3.2. Width 40.0 cm (15.8“)

2.4.4.3.3. Depth 30.0 cm (10.2“)

2.4.4.3.4. Weight 8.0 kg (17.6 lb.)

2.4.4.4. Injection Specs

2.4.4.4.1. Flow rate (range & increments)

2.4.4.4.2. 0.1–10 mL/sec in 0.1 mL increments

2.4.4.5. Volume (range & increments)

2.4.4.5.1. 1 mL to syringe capacity in 1 mL increments

2.4.4.6. Programmable pressure limit (psi/kPa)

2.4.4.6.1. 200 mL syringe: 325 psi, 2241 kPa

2.4.4.7. Scan delay

2.4.4.7.1. 0–300 seconds (5 minutes) in 1 second increments

2.4.4.8. Pause

2.4.4.8.1. 1–900 seconds (15 minutes) in 1 second increments

2.4.4.9. Hold

2.4.4.9.1. Maximum HOLD time is 20 minutes

2.4.4.10. Syringes (volume capacity)

2.4.4.10.1. 200 mL sterile disposable syringe

2.4.4.11. Maximum number of phases

2.4.4.11.1. 6

2.4.4.12. Electrical requirements (VAC/Hz)

2.4.4.12.1. 100–240 VAC, 50/60 Hz, 300 Volts-AMPs

2.4.4.13. Syringe heat maintainer

2.4.4.13.1. 35 degrees C ±5 degrees, 95 degrees F ±9 degrees

2.4.4.14. Head mounting options

2.4.4.14.1. Overhead counterpoise system or floor pedestal (floor pedestal includes an integral IV pole)

2.4.4.15. DualFlow

2.4.4.15.1. Simultaneous injection of contrast and saline is integrated in the CWS and included

2.4.4.16. Certegra P3T Cardiac Application

2.4.4.16.1. Cardiac CTA Protocol Optimization Software

2.4.4.17. Certegra P3T Abdomen Application

2.4.4.17.1. Abdominal Protocol Optimization Software

2.4.4.18. Certegra P3T Pulmonary Angiography Application

2.4.4.18.1. Pulmonary Angiography Protocol Optimization Software

2.4.4.19. Informatics Starter Package

2.4.4.19.1. Access to modality worklist and database of injections

2.4.4.20. PACS Outbound Interface

2.4.4.20.1. Send secondary capture of contrast injection to PACS

2.4.4.21. RIS Outbound Interface

2.4.4.21.1. Send contrast injection information to RIS

2.4.4.22. Speech Recognition Outbound Interface

2.4.4.22.1. Send contrast injection information to Speech Recognition System

2.4.4.23. Imaging System Interfacing (ISI)

2.4.4.23.1. Several types of interfacing with the scanner

2.4.4.24. VirtualCare

2.4.4.24.1. Remote service on the injector and software to ensure faster uptime

3. Specific Tasks:

3.1. The delivery and installation of two (2) Medrad Stellant Flex OCS CT Injection System

4. Place of Performance:

4.1. VA Pittsburgh Health Care System-University Drive

University Drive C Pittsburgh, PA 15240

5. VHA Supplemental Contract Requirements for Combatting COVID-19

5.1. Contractor employees who work in or travel to VHA locations must comply with the following:

5.1.1. Documentation requirements:

5.1.1.1. If fully vaccinated, contractors shall show proof of vaccination.

5.1.1.1.1. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS- 319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

5.1.1.2. If unvaccinated contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

5.1.1.3. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

5.1.1.4. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

5.1.2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

5.1.2.1. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

5.1.3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

5.1.4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.