Statement of Work NIAID-NOI-22-2107356.pdf

STATEMENT OF WORK

Background:

The National Institutes of Health (NIH) has constructed and is operating a biological high containment BSL4 (Biological Safety Level 4) Integrated Research Facility (IRF) at Fort Detrick, Maryland to enable the National Institute of Allergy and Infectious Diseases (NIAID) researchers to track disease processes and clinical outcomes of select agents and other emerging infectious diseases.

The IRF contains BSL2, 3, and 4 lab and support space with an advanced Imaging Core facility inside BSL4 containment. Commissioning and operating imaging suites within the BSL4 containment area is unprecedented. The Imaging Core is a central point of research activity at the IRF focusing on wholeanimal imaging to understand and monitor disease progression.

The Imaging Core in the BSL4 facility contains four modalities: MRI, PET/CT, SPECT/CT, and radiography. This statement of work pertains to three modalities: MRI, PET/CT, and SPECT/CT; the radiography equipment is not included in this Statement of Work (SOW). Equipment must be isolated from the imaging specimen to prevent contamination of the system and eliminate the possibility of infecting nonprotected personnel with experimental agents.

Purpose:

The purpose of this SOW is to outline service requirements for imaging equipment in the NIAID IRF. The equipment systems contain both commercial and proprietary noncommercial components. The noncommercial components were provided by the original equipment manufacturer Philips Healthcare. The company designed, developed, and implemented necessary modifications to standard, commercial diagnostic imaging equipment including MRI, PET/CT and SPECT/CT so that the equipment is capable of operating with some components of the respective devices inside BSL4 containment. Equipment Service Requirements include the following:

Maintenance and calibration that cannot be performed outside the containment zone shall be performed either once annually (post fumigation of space) or shall be performed in compliance with the standard and special practices as described in the Centers for Disease Control and Prevention Biosafety in Microbiological and Biomedical Laboratories (BMBL) for BSL4 suit laboratory space: http://www.cdc.gov /biosafety/publications/bmbl5/index.htm. In accordance with the above information on this website, the Contractor is to ensure compliance and document in their required reports.

Scope:

The contractor shall perform preventive, remedial maintenance and repair services to maintain the equipment in good working condition in accordance with the equipment manufacturer's specifications.

Requirements:

The contractor shall provide all service reports, materials, parts, test equipment, transportation, labor, and all other related services for servicing the imaging equipment at the IRF.

The IRF imaging personnel will assist in filling of phantoms and placing phantoms on imaging tables during the scheduled preventive maintenance and assist in performing tasks related to service on the highcontainment side of the imaging suites. The Contractor and the Government agree that the contractor's personnel will only access highcontainment areas if the ill functioning imaging system parts residing within the highcontainment environment cannot be serviced by one of the IRF imaging staff members. Opening of a highcontainment area requires performing a decontamination process and approval of entry by the Division of Occupational Health and Safety.

While the contractor's personnel are at the Government facility, the contractor shall be responsible for compliance with all the laws, rules, and regulations governing conduct at the IRF. Contractor will follow all Federal, State, and local laws related to the safety and health of personnel and property damage. Due to the security requirements imposed by the government the contractor personnel shall make appropriate arrangements for escorted entrance into IRF and into the imaging suites to perform diagnostics, preventive maintenance, and service on the equipment.

The Contractor may use its existing control process and systems that are currently in place as part of the Quality Control systems.

Quality Assurance

1) Interim approvals and testing shall include but may not be limited to:

a) Assistance by IRF staff as appropriate while the separation of containment and non containment barrier is subjected to withstand pressure decay test.

b) Material used within the containment shall be subject to decontamination and cleaning processes with the following sprayed chemicals: Lysol, MicroChem, ClidoxS and the following gas delivered chemicals: paraformaldehyde, chloride dioxide, vaporized hydrogen peroxide (VHP), and Quat TB.

c) Factory testing and validation is required for all material to be used in the containment area.

d) In the instance of a proposed modification to the installed equipment or surrounding environment, all interim testing and validation results shall be reviewed, witnessed, and approved by the Government, its contractors, or its representatives before being used for the modification. Contractor shall provide seven (7) business days’ notice of such test.

Equipment to Be Serviced:

All of the equipment to be serviced are Philips Medical Imaging Systems:

a) Magnetic Resonance 3T Achieva, Site #532851 (Serial #17226)

b) Gemini TF (Positron Emission Tomography (PET) and Computed Tomography Bio containment system (CT) Hybrid System) Site #42392378 (Serial #7010)

c) Precedence (Single Photon Emission Computed Tomography (SPECT) and Computed

Tomography (CT) Biocontainment System, Site #44605002 (Serial #340090)

The additional Philips Medical Systems Workstations:

a) Magnetic Resonance Extended Workstation (EWS), Site #42392379 (Serial #10839)

b) Philips Extended Brilliance Workspaces (EBW), Site #44605005 (Serial #11634)

The Philips Uninterrupted Power Supply Systems:

a. Philips MR MidTier System, Site #62073790

b. Chloride 80kVA 480V 60Hz PET UPS, Site #1334372

c. Chloride 80kVA 480V 60Hz SPECT UPS, Site #1334373

Service Requirements:

Equipment quality performance assurance service as scheduled to include a general system inspection and review of system operation, calibrating the system as necessary, system lubrication and filter replacement or cleaning, completing minor operational and reliability field engineering change notices or updates, and other remedial maintenance of a nonemergency nature. The Assurance Service named above shall include, but not be limited to, Performance Assurance Checks some of which are itemized below. Contractor shall provide such planned maintenance during the Service Coverage hours (as defined below) at a time that is mutually agreed upon; and

Repair service, due to equipment malfunction, as required. Repair service includes the cost of Philips replacement parts as required on an exchange (refurbished) or new OEM part basis and labor to install Philips replacement parts. Replaced parts may be retained by the Contractor.

Routine Maintenance Schedule:

a. Service on the Magnetic Resonance 3T Achieva will be performed two (2) times a year at threemonth intervals.

b. Service on the PET/CT system will be performed four (4) times a year at threemonth intervals.

c. Service on the SPECT/CT system will be performed two (2) times a year at threemonth intervals.

d. Philips clarifies that all PMs will be performed per OEM specifications.

Performance Assurance Checks:

a. MRI 3T Achieva System Level Checks 3 Months Spurious noise test batch System Level Checks 6 Months

Check impedance 50 Ohm QBC load Artifact Body coil (3.0T) B01 Artifact Body coil (3.0T) B02 Artifact Body coil (3.0T) B03 Artifact Body coil (3.0T) B04 Artifact Body coil (3.0T) B05 Artifact Body coil (3.0T) B06 Artifact Head coil (3.0T) H01 Artifact Head coil (3.0T) H02

Gradient System Coil 3 Months Check Gradient Coil Connections

Magnet System 6 Months Water drain He vent system inside RF enclosure He vent system outside RF enclosure

System Measurements & Adjustments 3 Months Tx att. Calibration Tune TX att. Calibration RX att. and INL calibration Max kW calibration body coil Max kW calibration TRHead coil F0 determination RF power ref. cal. Body coil Pickup coil tripl. cal. body coil RF power ref. cal. TRHead coil Pickup coil tr. cal TRHead coil

System Measurements & Adjustments 6 Months Channel Delay a& FID Shimming High order Shim Calib. for 3.0 T not XR System Level Checks (All Visits) 3 Months PIQT: Periodic Image Quality Test

Visual Inspection Filter/Fans Operator Equip. Cabinet

Check site conditions System Level Checks (Visit 3, 6) 6 Months

Check Stop Function Check Door Switch Check Helium overpressure Det.

Check Gradient Airflow Circuit Gradient Coil Temperature LCC Interlock Check Leakage Current Measurement

Impedance 50 Ohm QBC Load

Check:

Gradient Switch 6 Months Intera Gradient Switch Liquid Cooling, All Versions 3 Months Check of Water hoses

Liquid Cooling, LCC 9896 030 13903/4 and LCC 9896 030 13913/4 3 Months Check Coolant Level

Refrigerator: Check Compressor Pressure 3 Months CSW71 Supply Pressure

Optional. Helium Level & Boil Off 3 Months Boil off Helium Level Check Magnet Cables 2 Months Check magnet cables System Settings (Only Non SS Amp) 3 Months RF Ampl. Self Test (S23, S26 only) System Settings 3 Months Automatic CDAS Test CDAS calibration Max kW adjustment & PMU Test Resonance Frequency Determination Power reference measurement Pickup – coil measurement (S) Operator Console/PC 3 Months Monitor adjustment for OCD Clean the mouse (optional) Clean up disks Backup procedure Check statistical logging Configuration “As Maintained” Operator Console/PC 6 Months

Interactive display I/T maintenance Physiology battery replacement

b. Gemini Test 3 Months

Preparation Remove PET gantry covers Remove patient support covers Remove inbore lifter covers Open CT gantry front cover Remove CT gantry side and back covers

Safety Checks Check all of the Estops on the system Check the gantry control panels and scan control unit Check the rotating gantry frame (CT)

CT Subsystem Gantry inspections, adjustments, and cleaning Slipring inspection and cleaning Gantry main bearing lubrication Gantry optics inspection and cleaning Collimator verification Common console cleaning Host Rack / CIRS server exterior cleaning Protective ground measurements Automatic constancy test System software checks

Gantry Power Check the battery on the console UPS Check the battery on the CIRS UPS Check the battery on the UPS for the PET and patient support

Patient Support Check fan functionality Clean the upper and lower troughs Inspect, clean / replace upper table motor belt Lubricate the vertical drive screws Lubricate the linear rails of the upper and lower pallet Lubricate the lifters of the patient support Visually inspect inside of patient support for loose parts and cable wear Verify proper motion with and without the phantom holder

Gantry Separation Unit Check the GSU drive motor Inspect, Clean/Replace GSU Drive Belt and Pulley Wipe the linear rails of the GSU Flush the bearing blocks and regrease Check and grease slide cover Check for loose components Verify mechanical operation and alignment

Lifter Clean vertical column Inspect sensors on vertical column

PET Gantry Clean gantry fans, VME air filter, and TFE power supply minifans, clean TFE 1 board, measure ACQ and PRS motherboard temperatures and fan spin rates, clean air intakes at bottom of PET gantry covers Run the monthly uniformity check View emission scans Do image alignment calibration Check PET gantry for loose components

PET System Calibrations Verify and adjust all power supplies Auto gains (final) calibration GDR Test Energy correction Coincidence timing Normalization (576 FOV) Normalization (256 FOV) LOR normalization Image alignment calibration SUV validation SUV calibration, if the validation failed

c. Precedence Test 3 Months EStop CT Logger Laser (vertical and horizontal) Upper and lower pallet drive belts for wear and tension Check CT belt – main drive Poly V for wear and tension Clean the signal and power brush CT blocks Clean and inspect CT gantry optics

Check ground conduction for CT

Frame Visually inspect loose bolts, screws and nuts

Carriage Visually inspect bolts, screws and nuts – fastening hardware Check surfaces for damage or excessive wear – guides and racks

Arm Inspect ball screw Check for oil on cover of gear box Z Check surfaces for damage or excessive wear

Inspect for cracks or damage to arm/carriage mounting area Inspect for cracks or damage lower and upper arm mounting Check all connection points for tightness

Detector Verify the smooth operation and check for excessive noise

Exchanger Hardware Visually inspect for loose bolts, screws or nuts on cart hardware Check detector bucket sides for wear Check collimator dog brackets for wear

Table Check upper table pallet screws

Lubrication Apply lubricant to surface and fittings

Carriage YDrive rack/guides

Arm Thrust bearing Linear way Ball screw

Detector Collimator locking pin Rotate bearing

Table Rails Horizontal pallet lead screws Horizontal pallet lead

CT Calibrations Calibration: Perform phantom, air, and HCOR calibrations QA: Perform CT QA Backups: Backup CT calibrations to optical drive

SPECT Detector Tests Uncorrected intrinsic flood, center of rotation, backup SPECT validation SPECT calibration, if the validation failed

Final Clinical Tests Emission computed tomography study Total body study

Philips Uninterrupted Power Supply Systems:

Uninterrupted power supply systems shall have the batteries replaced at intervals no longer than five years after the most recent replacement, or sooner as necessary.

Batteries are not included in this service agreement.

Coverage:

Unless otherwise set forth elsewhere, Contractor will provide Customer Services Mondays through Fridays, 8:00 AM to 5:00 pm Customer local time, excluding Federal holidays ("Service Coverage").

Labor, travel, software patches and updates, and unlimited telephone technical assistance to maintain the equipment is to be included. Contractor must return all calls for service within two (2) hours and must be onsite within four (4) hours for emergency repairs.

Reporting Requirements:

NIAID and Contractor shall cooperate in defining the details required of each of the reports listed herein. Reports, documents, and manuals hereunder shall be provided in electronic format unless otherwise indicated.

Contractor shall provide the following reports to NIAID within thirty days of occurrence:

a. Minutes of any meetings relating to equipment performance or service issues.

b. Detailed reports of all service calls.

c. Validation test reports.

d. Quality and Regulatory status reports.

e. Other reasonable reports as identified.

f. Factory testing and validation is required for all material to be used in the containment area.

g. Testing, validation, and maintaining operation of peripheral accessories connected to the

Philips imaging equipment includes but not limited to ECG gating capabilities and power injectors.

h. All interim testing and validation results will be reviewed, witnessed, and approved by the Government, its contractors, or its representatives before being used for any system modification. Contractor shall provide seven (7) business days' notice of such test.