Medical Physicist Services - CTVHCS FY17
The Department of Veterans Affairs, will soon be posting a solicitation on or about 8-15-2016 for Physics services in support of the Veterans Affairs Central Texas Veterans Health Care System (CTVHCS) and OFF SITE CLINICS for the period of 10-1-2016 - 9-30-2017 and four (4) Option Years. Agencies interested in participating in the up-coming solicitation are encouraged to send a response to Mr. Ben Canales @ benito.canales2@va.gov conveying their accreditations and/or certification in this field of service. Please send responses with the subject titled: Medical Physicist Services, 674-17-1-5167-0001.
I. Description of Services.
1. Scope of Work. The Contractor shall provide all personnel, transportation, equipment and software to provide health physics consultation and diagnostic medical physicist services in support of the Veterans Affairs Central Texas Veterans Health Care System (CTVHCS) and OFF SITE CLINICS. These services will adhere to the requirements and expectations of the Nuclear Regulatory Commission (NRC), the National Council on Radiation Protection and Measurements (NCRP), the Mammography Quality Standards Act (MQSA), The Joint Commission (TJC), VHA National Health Physics Program (NHPP), the American College of Radiology (ACR), Food and Drug Administration (FDA), and internal requirements of this facility where applicable. The Texas Department of State Health Services regulations contained in 25 TAC B'289 are not in force at CTVHCS but shall be followed as closely as practical. Services shall be available Monday through Friday 8-4:30 excluding Federal holidays by performing the following tasks:
" Task 1: Annual review of CTVHCS overall Imaging Quality Assurance program for diagnostic imaging equipment. [NHPP];
" Task 2: Annual, not to exceed 14 months, quality assurance testing survey and certification of all diagnostic x-ray and imaging equipment (to include MRI and Nuclear Medicine imaging equipment). See Attachment A for list of existing equipment. This list may be modified (equipment added or removed) at any time. [TJC, NHPP];
" Task 3: Recertification of imaging equipment prior to first patient use when required due to repairs or modification that may affect the radiation output or image quality. Within 24 hours of contact, the contractor will coordinate with the affected service to have the recertification scheduled;
" Task 4: Written reports signed by the diagnostic medical physicist documenting the testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment. This must be completed on new diagnostic x-ray equipment prior to first patient use. The Contractor shall provide one copy of the physicist report to the RSO and one copy to the Chief of Biomedical Services within five working days of completion of the work. The report may be in electronic format. [TJC, NHPP];
" Task 5: Deficiencies or non-conformances found during reviews or testing which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports must be provided after testing to Biomedical Engineering so that CTVHCS will know that equipment can be immediately put into use. The qualified diagnostic medical physicist will perform a follow-up with Biomedical Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found and report result to the RSO;
" Task 6: Dose rate surveys in unrestricted areas adjacent to the radiation areas are to be included during testing and in the final report;
" Task 7: A patient exposure chart will be provided for each unit inspected for common projections and procedures;
" Task 8: Shielding design specification calculations for new construction and renovations. [TJC, NHPP]
" Task 9: Shielding certification surveys following new construction, modifications and replacement of equipment. [TJC, NHPP]
" Task 10: Annual quality assurance testing of mammography equipment. [MQSA]
" Task 11: Support the CTVHCS Radiation Safety Office by membership and/or attendance at the appropriate CTVHCS committee meetings (i.e., Radiation Safety Committee, Computed Tomography Working Group, Fluoroscopy Safety Working Group) on a quarterly or as needed basis. The CTVHCS Radiation Safety Office expects the diagnostic medical physicist to be available to attend these meetings not less than 2 hours per quarter. [TJC]
" Task 12: Provide consultation for dose estimates calculations for patient, staff and fetal exposures and sentinel event investigations.
" Task 13: Emergency response time on equipment tests within 48 hours.
" Task 14: Quarterly on-site health physics/regulatory compliance surveys of the Nuclear Medicine, Radiation Safety Office, and of Research locations of use (when applicable). These surveys will take place in the first two weeks of January, April, July, October and include:
o Sealed source inventories
o Sealed source leak tests (NRC, NHPP)
o Performance based audits of Nuclear Medicine practices/procedures
o Records of research acquisitions, contamination surveys, and disposals (if applicable)
" Task 15: Semi-annual audits of Nuclear Medicine Written Directive case records.
The annual (not to exceed 14 months) quality assurance testing will include all radiology and dental equipment at CTVHCS - Temple, Waco, Austin, and off site outpatient clinics - Brownwood, Bryan/College Station, Cedar Park, and Palestine. All quality assurance testing reports and mammography equipment performance evaluations reports shall be submitted to the CTVHCS Radiation Safety Office for review and approval subsequent to the completion of all testing, calibration and surveys of the equipment, facilities and procedures. The reports shall identify all items of noncompliance and include general and specific recommendations for correcting any items of noncompliance. All records (administrative and program specific) created during the period of the contract belong to VA Central Texas Health Care System(CTVHCS) and must be returned to CTVHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.
1.1. Quality Assurance Testing
1.1.1. All Quality Assurance Tests shall meet or exceed current and possible future changes in NRC, ACR, MQSA, NCRP, FDA and TJC requirements and recommendations. All Quality Assurance Tests shall meet or exceed the requirements in the following VHA directives and handbooks and future directives and handbooks :
" VHA Directive 1105.01, Management of Radioactive Materials
" VHA Handbook 1105.02, Nuclear Medicine and Radiation Safety Service
" VHA Handbook 1105.03, Mammography Program Procedures and Standards
" VHA Handbook 1105.04, Fluoroscopy Safety
" VHA Handbook 1105.05, MRI Safety
" VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation
1.1.2. Diagnostic X-ray Equipment (Radiography and Fluoroscopy)
The annual testing must include, but is not necessarily limited to, the following (as applicable):
Per VHA Handbook 1105.04, Fluoroscopy Safety:
" Measurement of radiation output parameters, including beam intensity and beam quality;
" Testing of all modes of operation used clinically, including automatic exposure rate controls of fluoroscopy systems;
" Assessment of image quality;
" Assessment of technique factors used clinically;
" Measurement of appropriate indices of patient dose output chart must be generated for each survey in accordance 25 TAC. Dose rates at typical clinical technique factors, with comparison to national standards;
Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiologic and Fluoroscopic Equipment:
" Integrity of unit assembly
" Collimation and radiation beam alignment
" Fluoroscopic system resolution
" Automatic exposure control system performance
" Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation)
" Image artifacts
" Fluoroscopic phantom image quality
" kVp accuracy and reproducibility
" Linearity of exposure versus Ma or mAs
" Exposure reproducibility
" Timer accuracy
" Beam quality assessment (half-value layer)
" Fluoroscopic entrance exposure rates
" Image receptor entrance exposure
" Equipment radiation safety functions
" Patient dose monitoring system calibration
" Video and digital monitor performance
" Digital image receptor performance
If the review of clinically-used technique factors or the comparison of measured dose indices with national standards indicates that an optimum balance has not been achieved between patient dose and image quality or that the dose indices exceed national standards, the technique factors, whether posted in a chart or programmed into the fluoroscope, must be modified as necessary. [VHA Handbook 1105.04]
Reports shall be generated indicating appropriate indices of patient dose, measured by a diagnostic medical physicist at clinically-used technique factors, to be posted near the controls of each fluoroscope. These indices include typical and maximal entrance skin dose or air kerma rate for each fluoroscopic mode of operation (e.g., pulse rate and magnification mode). For each image recording mode used clinically, these include the entrance skin dose or air kerma per image or the entrance skin dose or air kerma per second of imaging (e.g., cinefluorography in the cardiac catheterization laboratory) for a patient of typical thickness. [VHA Handbook 1105.04]
1.1.3. Computed Tomography
The testing must include, but is not necessarily limited to, the following (as applicable):
Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment:
" Alignment light accuracy
" Image localization from scanned projection radiograph (localization image)
" Table incrementation accuracy
" Radiation beam width (collimation)
" Reconstructed image thickness
" Image quality
o High-contrast (spatial) resolution
o Low-contrast sensitivity and resolution
o Image uniformity
o Noise
o Artifact evaluation
" CT number accuracy
" Acquisition workstation display
" Dosimetry
o Radiation output of CT scanner (CT dose index [CTDIvol] or equivalent)
o Patient radiation dose estimate for representative examinations
" Protocol review
o The Diagnostic Medical Physicist shall become a member of computed tomography working group (CTWG) and review the CT protocols annually. These should include head and abdomen protocols for adult and pediatric patients as applicable to the facility's practice. In addition, facility protocols for very high dose procedures (e.g., brain perfusion) should be reviewed.
o Elements reviewed should include documentation of kVp, Ma, rotation time, detector configuration, pitch, reconstructed image thickness, and use of automatic exposure control (including ensuring documentation of reference settings used), and the indicated dose indices (CTDIvol) resulting from each examination
" Safety Evaluation
o Visual inspection
o Work load assessment
o Scatter and stray radiation measurements (if work load and other related parameters have changed since acceptance testing)
o Audible/visual signals
o Posting requirements
" Other tests as required by state or local regulations
Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):
" Image uniformity
" Slice thickness accuracy
" Slice position accuracy (when prescribed from a scout image)
" Alignment light accuracy
" Table travel accuracy
" Radiation beam width
" High-contrast resolution
" Low-contrast resolution
" Geometric or distance accuracy
" CT number accuracy and uniformity
" Artifact evaluation
" Dosimetry
o The diagnostic medical physicist measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following four CT protocols: adult brain, adult abdomen, pediatric brain and pediatric abdomen, as applicable. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.
o The diagnostic medical physicist verifies that the radiation dose (in the form of CTDIvol) displayed by the CT imaging system for each tested protocol is within 20 percent of the CTDIvol displayed on the CT console. The dates, results, and verifications of these measurements are documented.
" Image acquisition display monitors
o Maximum luminance
o Minimum luminance
o Luminance uniformity
o Resolution
o Spatial accuracy
1.1.4. Mammography
The annual testing must comply with the MQSA and the latest requirements posted on the ACR Website for the manufacturer of the digital mammography being inspected. It must include, but is not necessarily limited to, the following (as applicable):
" Unit assembly evaluation
" Collimation assessment
" Artifact evaluation
" kVp accuracy and reproducibility
" Bean quality assessment - HVL measurements
" Evaluation of system resolution
" Automatic Exposure Control (AEC) function performance
" Breast entrance exposure, AEC reproducibility, and average glandular dose
" Radiation output rate
" Phantom image quality evaluation
" Signal to noise ratio and contrast to noise ratio measurements
" View box luminance and room illuminance
" Review work station (RWS) tests
1.1.5. MRI Equipment
The testing must include, but is not necessarily limited to, the following (as applicable):
Per the American College of Radiology Technical Standard for Diagnostic Medical Physics Performance Monitoring of Magnetic Resonance Imaging (MRI) Equipment:
" Magnetic field homogeneity
" Slice position accuracy
" Slice thickness accuracy
" Radiofrequency (RF) calibration for all coils
o Frequency and gain/attenuator verification (prescan values)
o Image signal-to-noise ratio (SNR) for all coils
o Intensity uniformity for all volume coils
o Phase stability and image artifact assessment for all coils
" Softcopy (monitor) fidelity
" Evaluation of quality control (QC) program
Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):
" Image uniformity for all radiofrequency (RF) coils used clinically
" Signal-to-noise ratio (SNR) for all coils used clinically
" Slice thickness accuracy
" Slice position accuracy
" Alignment light accuracy
" High-contrast resolution
" Low-contrast resolution (or contrast-to-noise ratio)
" Geometric or distance accuracy
" Magnetic field homogeneity
" Artifact evaluation
" Image acquisition display monitors
o Maximum luminance
o Minimum luminance
o Luminance uniformity
o Resolution
o Spatial accuracy
1.1.6. Nuclear Medicine Cameras
The annual testing must include, but is not necessarily limited to, the following (as applicable):
Per the TJC Revised Requirements for Diagnostic Imaging Services (Prepublication Requirements dated January 9, 2015; subject to change):
" Evaluation of all nuclear medicine image types by each NM scanner and include the use of phantoms to assess the following imaging metrics:
o Image uniformity/system uniformity
o High-contrast resolution/system spatial resolution
o Sensitivity
o Energy resolution
o Count-rate performance
o Artifact evaluation
o Low-contrast resolution or detectability for non-planar acquisitions (recommended not required)
1.1.7. Computed Radiography (CR) and Digital Radiography (DR)
The annual testing must comply with the AAPM Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems and include, but is not necessarily limited to, the following (as applicable):
" Component and imaging plate physical inspection and inventory
" Imaging plate dark noise and uniformity
" Exposure indicator calibration
" Linearity and auto-ranging response
" Laser beam function
" Limiting resolution and resolution uniformity
" Noise and low-contrast resolution
" Spatial accuracy
" Erasure thoroughness
" Aliasing/grid response
" IP throughput
" Positioning and collimation errors.
1.1.8. Dental
The physics inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities July 2001. The annual testing must include, but is not necessarily limited to, the following (as applicable):
" Collimation
" Beam quality (HVL)
" Timer accuracy and reproducibility
" kVp accuracy and reproducibility
" mA or mAs linearity
" Exposure reproducibility
" Entrance skin exposure evaluation, with comparisons to published diagnostic reference levels and achievable doses (e.g. NCRP Report No. 172)
" Technique chart evaluation
" Image uniformity (artifact evaluation)
1.1.9. Dental CBCT
If the manufacturer has provided 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. The annual performance testing must include, but is not necessarily limited to, the following (as applicable):
" Radiation output repeatability and reproducibility
" kVp accuracy, repeatability, and reproducibility
" Bean quality
" Radiation field of view (FOV)
" Image quality
" Accuracy of linear measurements
" Accuracy of patient dose metric indication
" Patient dose assessment
" Review of the technical QA program
" Display monitor evaluation
o Test pattern evaluation
o Monitor brightness
o Viewing conditions
1.1.10. PET/CT
The annual physics inspection shall conform to the ACR PET Phantom Instructions for Evaluation of PET Image., ACR Nuclear Medicine Accreditation Program PET Module. Regarding the CT component, this evaluation should include items of the CT inspection, but not be limited to the following tests (as applicable):
" Uniformity
" Spatial resolution
" SUV analysis
1.2. Structural Shielding
1.2.1. For any room in which a fluoroscopic imaging system is installed, or in which a mobile fluoroscopic imaging system is frequently used, the doses to persons in adjacent areas, including any areas above and below, must be evaluated by a qualified diagnostic medical physicist. Structural shielding must be installed as necessary to maintain doses to persons in these areas ALARA and within regulatory limits. [VHA Directive 1129 and VHA Handbook 1105.04]
1.2.2. For the structural shielding of rooms containing x-ray imaging devices, the shielding design goal must be 5 milligray (mGy) in a year to any person in a controlled area. For uncontrolled areas, the shielding design goal needs to be 1 mGy in a year to any person, and 0.02 mGy in any hour. [VHA Handbook 1105.04]
1.2.3. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations of shielding for each for and acceptance testing surveys of imaging rooms must conform to National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities and for dental units, NCRP Report No. 145. The calculations and testing must be documented in a written report which includes a diagram showing the 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. A written report of the shielding survey shall be provided to the RSO within 5 working days after the shielding survey has been completed. [VHA Handbook 1105.04]
2.1. Qualifications. Prior to commencing work, all contractor employees shall meet certain criteria to perform work under this contract as a Diagnostic Medical Physicist. Qualification documents must be submitted as part of the bid to the Contracting Officer and be approved by the RSO or his/her designee. All qualifications are subject to review by the CTVHCS Radiation Safety Committee.
2.1.1. Diagnostic Medical Physicist:
2.1.1.1. The Diagnostic Medical Physicist who performs the work at CTVHCS shall meet the following education, certification, and qualification standards:
" Hold a graduate degree in physics, medical physics, biophysics, radiological physics, medical health physics, or a closely related science or engineering discipline from an accredited college or a university.
" Formal graduate level college coursework in the biological sciences with at least one course in biology or radiation biology and one course in anatomy, physiology, or a similar topic related to the practice of medical physics.
" Documented 3 years of clinical experience in CT, nuclear medicine, PET/CT, or MRI. The physicist must document the 3 years of experience for the modality being inspected.
" Hold current Board Certification by the American Board of Radiology or American Board of Medical Physics.
" Licensed by the State of Texas as a Professional Medical Physicist.
" Meet all respective NRC, ACR, MQSA, FDA and TJC requirements for a qualified diagnostic medical physicist.
" A physicist in training or under a temporary license must be accompanied at any visit by and directly supervised by a fully licensed qualified diagnostic medical physicist.
2.1.1.2. The Diagnostic Medical Physicist shall have current knowledge, understanding, and recent experience in the following:
" All Texas Department of State Health Services, Radiation Control Regulations,
" All current NRC regulations,
" All current FDA regulations (including MQSA),
" Current recommendations of the ACR and TJC on diagnostic x-ray and imaging equipment
" Current recommendations of the NCRP and AAPM on medical imaging facility design and shielding,
" Current techniques for the calibration and testing of diagnostic x-ray equipment.
3.1 Period of Performance will be from October 1, 2016 thru September 30, 2017. This contract will include four option periods (each option period is equal to one year).
End of Statement of Work
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ATTACHMENT A
CTVHCS X-Ray Machines By Service
Cardiac Cath
Manufacturer Model Location
Phillips Allura FD2 TEMPLE
Dental
Manufacturer Model Location
Gendex GX1000 WACO
Gendex GX770 TEMPLE
Gendex GX770 WACO
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Instrumentarium OP 300 AUSTIN
Instrumentarium OP 300-1 TEMPLE
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex Expert DC AUSTIN
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex GX770 TEMPLE
Gendex DP300 WACO
Gendex Expert DC TEMPLE
Nuclear Medicine
Manufacturer Model Location
Spectrum Dynamics DSPECT L TEMPLE
General Electric Infinia Ha TEMPLE
General Electric Infinia GP TEMPLE
General Electric Discovery TEMPLE
General Electric Millineum TEMPLE
LUNAR Prodigy H8 TEMPLE
Radiology
Manufacturer Model Location
Phillips DR TEMPLE
Philips Optimus WACO
Phillips DR Digital AUSTIN
Phillips Optimus 50 BRYAN/COLLEGE STATION
X-Cel MB700BC WACO
Siemens Sireskop 3 TEMPLE
Phillips Diagnost D TEMPLE
Phillips Eleva TEMPLE
Toshiba Aquillion AUSTIN
Phillips Optimus 50 CEDAR PARK
Phillips Optimus 50 BROWNWOOD
Siemens Multi-Vert TEMPLE
Phillips Optimus 50 PALESTINE
Phillips Eleva AUSTIN
Phillips Eleva AUSTIN
Phillips Eleva TEMPLE
Shimadzu DaRt Evolution TEMPLE
Shimadzu DaRt Evolution TEMPLE
Shimadzu DaRt Evolution TEMPLE
Shimadzu DaRt Evolution TEMPLE
Phillips DR TEMPLE
X-Cel MB 900 TEMPLE
TOSHIBA Aquilion16 TEMPLE
Toshiba Aquilion16 WACO
Hologic Lorad AUSTIN
Toshiba Aquilion16 TEMPLE
General Electric Definium 8 WACO
General Electric Definium 8 TEMPLE
TOSHIBA Aquilion64 TEMPLE
Lunar Prodigy Ad AUSTIN
X-Cel FB900 AUSTIN
X-Cel FB900 TEMPLE
Hologic Selenia 2D TEMPLE
Toshiba MRI TEMPLE
Siemens Magnetom E TEMPLE
Siemens Espree AUSTIN
Surgical
Manufacturer Model Location
Phillips Veradius TEMPLE
OrthoScan HD1000 TEMPLE
Liebel-Flarsheim Hydrovision TEMPLE
General Electric OEC 9900 E TEMPLE
General Electric OEC 9900 E TEMPLE
General Electric OEC 9900 E TEMPLE
Urology
Manufacturer Model Location
Liebel-Flarsheim Unspecified AUSTIN
Liebel-Flarsheim Hydrovision TEMPLE
Ben Canales
benito.canales2@va.gov
