Draft SOW-MP 2027.docx

Diagnostic Medical Physics Support and Services

Draft Statement of Work Diagnostic Medical Physics Support and Services

The Contractor shall furnish all labor, materials, supplies, equipment, travel costs, and qualified personnel to provide diagnostic medical physics support or services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must meet the requirements of the National Health Physics Program, Veterans Health Administration directives, the Joint Commission, and the American College of Radiology.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO).

Services will be provided at VA Central California Health Care System in Fresno, California and its Community Based Outpatient Clinic (CBOC) located 50 miles south in Visalia, California.

VA Fresno Medical Center 2615 E. Clinton Ave.

Fresno, CA 93703

Visalia CBOC 500 North Santa Fe Street Visalia, CA 93292

General Requirements

1. Performance

All work shall be performed by a qualified diagnostic medical physicist. A qualified diagnostic medical physicist is a person who is certified by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine.

2. Mandatory Services to be Performed

a. All imaging equipment shall be performance tested at least annually, not to exceed 14 months. Other inspections as defined below (new equipment, repairs, shielding, etc.) shall be completed as needed by VACCHCS. A complete electronic report in “pdf” format shall be provided to Biomedical Engineering and RSO within 10 working days after completion of the inspection. Written report of the results shall be provided within 30 working days after completion of the inspection. Missed or errors in performance for required elements will be corrected at the expense of the contractor. If errors are found in reports, corrections in “pdf” form will be submitted expeditiously.

b. The qualified diagnostic medical physicist shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, PET/CT cameras, ultrasound units, and MRIs) inspections to ensure compliance with the current American College of Radiology (ACR) and Mammography Quality Standards Act (MQSA) requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery.

c. The qualified diagnostic medical physicist shall perform acceptance testing of all new or relocated imaging equipment prior to first clinical use. The acceptance testing shall comply with ACR or MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to Biomedical Engineering and the RSO immediately upon discovery.

d. The qualified diagnostic medical physicist shall perform a full performance testing of imaging equipment after repairs or modifications that may affect the radiation output or image quality where required. The inspection shall be completed within 72 hours after the facility contacts the contractor, in cases where the unit may not be used clinically until inspected by a physicist. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and the RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to Biomedical Engineering and the RSO immediately upon discovery. Where acceptable, the physicist will review and accept the repairs report from Engineering.

e. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, i.e., Safety training, CT optimization meetings, Nuclear Medicine lab audit, dosimetry program, patient or fetal radiation dose estimates.

f. The qualified diagnostic medical physicist shall review CT protocols upon request.

g. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147 (or most recent version), and, for dental units, NCRP Report No. 145 (or most recent version), and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic medical physicist shall perform a shielding survey to verify the structural shielding was installed per the shielding design report and complies with the design goals.

h. The qualified diagnostic medical physicist shall assist in the development of a comprehensive technical quality assurance (QA) program (e.g., technique charts, repeat/reject analysis monitoring, monitoring of exposure indices to radiographic image receptors, QA program for display monitors, QA for CT, monitoring of dose metrics from fluoroscopy studies), which complies with ACR recommendations, for all modalities. The qualified diagnostic medical physicist shall review at least annually the QA program.

i. The qualified diagnostic medical physicist shall review the report from Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found. The contractor will perform a follow-up inspection if necessary, according to ACR, MQSA, or other relevant standards.

j. The qualified diagnostic medical physicist shall test radiographic imaging systems, so that entrance skin exposure or air kerma data be acquired for phantoms representing standard size patients for common radiographic projections and that these data be compared to published diagnostic reference levels and achievable doses.

k. The qualified diagnostic medical physicist shall provide MRI Safety Expert services in accordance with VHA Directive 1105.05 Magnetic Resonance Safety. They will need to:

a. Provide guidance to the facility Radiology Service Chief on the clinical and administrative aspects of the safe use of MR equipment; the development of local rules and procedures related to MR safety; nonroutine MR processes; including but not limited to implanted medical devices; and the development and maintenance of MR safety programs and MR Quality Assurance programs.

b. Provide assistance and consultation to the MRSO and MRMD on the development of MRI protocols to allow the safe imaging of patients with MRI conditional implanted devices.

c. Actively participate in the planning, installation, and acceptance testing for new equipment at the VA medical facility.

d. Serve as the VA medical facility subject matter expert for any new root cause analyses or administrative investigations related to MRI adverse events.

3. Equipment Inspections

The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below. The Contractor shall ensure the imaging equipment’s compliance with applicable Federal regulations and ACR recommendations, and shall include, but not be limited to, monitoring the following basic performance characteristics.

A. Radiographic and Fluoroscopic Equipment

Physics inspections of radiographic and fluoroscopic equipment shall comply with the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. The performance of each radiographic and fluoroscopic unit must be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Integrity of unit assembly.

(2) Collimation and radiation beam alignment.

(3) Fluoroscopic system spatial resolution.

(4) Automatic exposure control system performance.

(5) Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed -modes, field-of-view [FOV] variation).

(6) Image artifacts.

(7) Fluoroscopic phantom image quality.

(8) kVp accuracy and reproducibility.

(9) Linearity of exposure versus mA or mAs.

(10) Exposure reproducibility.

(11) Timer accuracy.

(12) Beam quality assessment (half-value layer).

(13) Fluoroscopic entrance exposure rate (or air kerma rate). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation [e.g., magnification mode, frame rate, and any other mode selected) must be documented for each measurement.]

(14) Fluorographic (image recording) entrance exposure rate (or air kerma rate) for cine imaging, if performed and entrance exposure (or air kerma) for spot images (if performed). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation (e.g., magnification mode, frame rate, etc.) must be documented for each measurement.]

(15) Image receptor entrance exposure.

(16) Equipment radiation safety functions.

(17) Patient dose monitoring system calibration. This includes, for radiographic systems, the metric of dose to the image receptor (IEC Exposure Index or proprietary index) and, for fluoroscopy systems, the displays of cumulative air kerma and, if available, DAP.

(18) Display monitor performance.

(19) Digital image receptor performance.

(20) Grids used with portable x-ray units shall be imaged for uniformity.

(21) For radiographic units, measurement of entrance skin exposure (or air kerma) for a standard size patient for common radiographic projections and comparison to published diagnostic reference levels and achievable doses (e.g., ACR practice parameter.

Note: The information on entrance exposure rates (or air kerma rates) from fluoroscopy and from fluorography, in Items (13) and (14) above, for each fluoroscope, shall be in a format suitable for providing to the physicians who operate the fluoroscope.

B. Digital Radiography (DR)

Physics inspections of DR equipment shall comply with the American Association of Physicist in Medicine (AAPM) Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems. The performance of DR must be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Component and Imaging Plate Physical Inspection and Inventory.

(2) Imaging Plate Dark Noise and Uniformity.

(3) Exposure Indicator Calibration.

(4) Linearity and Auto-ranging Response.

(5) Laser Beam Function.

(6) Limiting Resolution and Resolution Uniformity.

(7) Noise and Low-Contrast Resolution.

(8) Spatial Accuracy.

(9) Erasure Thoroughness.

(10) Aliasing/Grid Response.

(11) IP Throughput.

(12) Positioning and Collimation Errors.

(13) Radiographic imaging entrance exposure rate (or air kerma rate). Maximum output and output using a phantom representing a standard size patient for common radiographic projections and compare this data to published diagnostic reference levels and achievable doses.

C. CT Scanners

The physics inspection shall conform to the ACR Computed Tomography Quality Control Manual or latest revision. The performance of each CT scanner shall be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Review of Clinical Protocols.

(2) Scout Prescription and Alignment Light Accuracy.

(3) Image Thickness – Axial Mode.

(4) Table Travel Accuracy.

(5) Radiation Beam Width.

(6) Low-Contrast Performance.

(7) Spatial Resolution.

(8) CT Number Accuracy.

(9) Artifact Evaluation.

(10) CT Number Uniformity.

(11) Dosimetry (the scanner displayed CTDIvol values must be within +/- 20% of the measured CTDIvol values).

(12) Gray Level Performance of CT Acquisition Display Monitors.

D. Dental

The physics inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography. The performance of dental x-ray inspections shall be completed annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Collimation.

(2) Beam quality (half value layer).

(3) Timer Accuracy and Reproducibility.

(4) kVp Accuracy and Reproducibility.

(5) mA or mAs Linearity.

(6) Exposure Reproducibility.

(7) Entrance Skin Exposure Evaluation, with comparison to published diagnostic reference levels and achievable doses (e.g., NCRP Report No. 172).

(8) Technique Chart Evaluation.

(9) Image uniformity (artifact evaluation).

Dental CBCT Acceptance and Performance Testing

1. Acceptance Testing. Acceptance testing and measurements of air kerma at the isocenter for each kVp station for a range of clinically used mAs settings will performed initially when the CBCT unit is installed, and following any move of the CBCT to another area inside or outside the initial clinical site. This testing is to ensure that the equipment performance is in agreement with the manufacturer’s technical specifications.

2. Performance Testing. Each CBCT unit shall undergo periodic quality control tests to insure that the performance of the machine has not significantly deteriorated and is operating within the manufacturer’s technical specifications. This performance testing is performed by a qualified expert annually, at intervals not to exceed 14 months, and after repairs to the CBCT unit that may affect the radiation output or image quality.

3. Some manufacturers provide a phantom and procedures to perform machine specific quality assurance (QA) tests. In cases where the manufacturer provides a phantom and procedures to perform specific tests but the tests are not included in this SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW.

Acceptance and Annual physics testing for Dental CBCT

1. Radiation output Repeatability Make four measurements of the air kerma at the isocenter at a clinically used setting. The measurements should be less than +/-5% of the average of the five measurements and the measurements should be less than +/- 5% of the previous year’s measurement.

2. Radiation Output Reproducibility Measure the air kerma at the isocenter for each kVp station and a range of clinically used mAs setting. Compare the results to the baseline values established at the initial acceptance testing. The values should be +/-5% of the baseline.

3. kVp Accuracy Measure the kVp at all clinically used settings. The measured kVp should be +/-5% of the selected kVp.

4. kVp Repeatability Make five kVp measurements each for two clinically used kVp settings. All measured values should be +/-5% of the mean kVp.

5. kVp Reproducibility Measure the kVp at all available kVp settings. The measured values should be +/-5% of the baseline.

6. Beam quality Measure the half value layer (HVL) for aluminum. The minimum shall comply with Section F.4.d of the Suggested State Regulations for Control of Radiation, Conference of Radiation Control Program Directors.

7. Radiation field of view (FOV) Measure the width of the radiation field at the isocenter. The width of the beam should be 3 mm or 30% of the total nominal collimated width.

8. Image Quality Image the phantom provided by the manufacturer or another suitable phantom. Assess high contrast spatial resolution, uniformity of transaxial images, and image noise. Imaging uniformity shall be assessed over the entire range of axial images.

9. Accuracy of Linear Measurements Using images of an appropriate phantom, assess the accuracy of distance measurements.

10. Accuracy of Patient Dose Metric Indication Assess the accuracy of the indicated dose metric (typically DAP).

11. Patient Dose Assessment From a scan or scans using the facility’s standard techniques, record the dose metric (typically DAP) and compare to achievable levels and diagnostic reference levels (if available)

12. Review of the technical QA program The qualified expert shall review the technical QA program. The review shall include a trend analysis of the QA data. The results of the technical QA program review shall be included in the written report. Any trends that identify problems shall be included in the report along with recommended corrective actions.

13. Display Monitors Perform a visual analysis of the SMPTE test pattern.

1. Display the test pattern on the imaging console. Set the display window width/level to the manufacturer-specified values for the pattern. Do not set the window/level by eye; doing so invalidates the procedure.

1. Examine the pattern to confirm that the gray level display in the imaging console is subjectively correct.

1. Review the line pair patterns in the center and at each of the corners.

1. Review the black-white transition.

1. Look for any evidence of “scalloping” (loss of bit depth) or geometric distortion.

1. Use a photometer to measure the maximum and minimum monitor brightness (0% and 100% steps)

1. Measure additional steps within the pattern to establish a response curve.

1. Measure the brightness near the center of the monitor and near all 4 corners (or all 4 sides, depending on the test pattern used).

14. Viewing Conditions Assess the viewing conditions for the area in which the monitor used to evaluation the CBCT studies is located.

E. MRI

The physics inspection shall conform to the ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI scanner shall be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Magnetic field homogeneity.

(2) Geometric accuracy.

(3) Inter-slice RF interference.

(4) Slice position accuracy.

(5) High-contrast resolution

(6) RF coil performance.

(a) Volume coils’ signal-to-noise ratio

(b) Volume coils’ image uniformity

(c) Volume coils’ ghosting ratio

(d) Phased array coils' signal-to-noise ratio

(e) Surface coils’ signal-to-noise ratio

(7) Slice thickness accuracy

(8) Low-contrast detectability

(9) Soft copy displays

(10) Technologist’s QC program

(11) Site phantom inventory

(12) Site RF coil inventory

F. PET

The physics inspection shall conform to the ACR PET Phantom Instructions for Evaluation of PET Image, ACR Nuclear Medicine Accreditation Program PET Module. For PET/CT units the CT must be inspected at least annually per Item C above. The performance of each PET scanner shall be evaluated at least quarterly. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Uniformity.

(2) Spatial resolution.

(3) SUV analysis.

G. Nuclear Medicine

The physics inspection shall conform to the ACR performance tests for nuclear medicine cameras. The qualified diagnostic medical physics shall also perform the quarterly testing as outlined by the ACR. The performance of each nuclear medicine scanner shall be at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Intrinsic Uniformity

(2) System Uniformity

(3) Intrinsic or System Spatial Resolution

(4) Relative Sensitivity

(5) Energy Resolution

(6) Count Rate Parameters

(7) Formatter/Video Display

(8) Overall System Performance for SPECT

(9) System Interlocks

(10) Dose Calibrators (Geometry, Linearity, Efficiency, & Accuracy)

(11) Thyroid Uptake and Counting Systems

(12) Department Audit-Sealed Sources Leak Test and Inventory

H. Ultrasound

The physics inspection shall conform to the ACR performance tests for ultrasound. Testing should be done for all transducers clinically used with any unit employing more than one transducer.

(1) System Sensitivity/Penetration This test should be done with the following settings:

· maximum transmit power

· proper receiver gain and TGC that allows echo texture to be visible in the deep region

· transmit focus at the deepest depth The maximum depth of visualization is determined by comparing the gradually weakening echo texture to electronic noises near the bottom of the image.

(2) Image Uniformity Adjust the TGC controls and other sensitivity controls to obtain an image as uniform as possible.

· vertical or radially oriented streaks?

· dropouts?

· reduction of brightness near edges of the scan?

· brightness transitions between focal zones?

(3) Electrical and Mechanical Safety and Cleanliness

· Are all cords and cables intact (no frays)?

· Are all transducers intact without cracks or delamination?

· Are the transducers cleaned after each use?

· Are the image monitors clean?

· Are the air filters clean?

· Are the wheel locks in working condition?

· Are the wheels fastened securely to the US unit and do the wheels rotate easily?

· Are all accessories (VCR, cameras, etc.) fastened securely to the US unit?

(4) Gray Scale Photography (if applicable) – Do either (a), (b), or (c).

(a) For Scanners with a Discrete Bar Pattern Count the number of distinct gray bar steps on the viewing monitor. Then count the number of steps visualized in the gray bar on the hard copy image.

(b) For Scanners with a Continuous Gray Bar Pattern Use calipers to measure the length of the black-to-white transition of the gray wedge on the viewing monitor. If the relative length of the black-to-white transition on the hard copy image is less, document how much is missing.

(c) For Laser Imager (Hard Copy Device) Prior to filming any images, an SMPTE test pattern created by the Society of Motion Picture and Television Engineers (SMPTE), should be printed using the appropriate window width (WW) and window level (WL). If you are unfamiliar with this procedure, you should review Gray et al., “Test pattern for video display and hard-copy camera,” Radiology 145:519-527 (1985), and then contact your local service engineer for assistance. When printed, the 95% density patch within the 100% square and the 5% density patch within the 0% square should be visible, and there should be no notable distortions or artifacts present. If these criteria are not met, contact your service engineer for laser camera calibration before proceeding with any filming.

(5) Hard Copy Output Quality Test (Digital) (if applicable) This test, or a similar test specifically recommended by the hard copy equipment manufacturer.

Required Test Equipment

· Densitometer

· SMPTE Test Pattern or another similar test pattern or phantom image having a wide range of gray scales.

The same test image should be used each time.

I. Display Monitors

The annual performance evaluation conducted by the diagnostic medical physicist includes testing of image acquisition display monitors for maximum and minimum luminance, luminance uniformity, resolution, and spatial accuracy. The image acquisition display monitors for nuclear medicine, CT, and MRI units shall be tested.

4. VACCHCS Initial (Current: 2026) Equipment List

VACCHCS Current Equipment List

58412

5. PERFORMANCE MONITORING

The Radiation Safety Officer (RSO) will monitor contractor performance and certify the work was done in accordance with the SOW.

6. INFORMATION SECURITY

The C&A requirements do not apply. Security Accreditation Package is not required.