667-15-3-066-0464-Annual X-ray equipment service by medical physicist Base plus four (4) - twelve (12) month options

Statement of Work



Medical Physicist Services







Overton Brooks VA Medical Center

























I. Description of Services.



1. Scope of Work. The Contractor shall provide all personnel, transportation, equipment (including the ACR phantoms necessary for quality assurance testing) and software to provide diagnostic medical physicist services in support of Overton Brooks VA Medical Center (OBVAMC) by performing the following tasks:



" Task 1: Review of OBVAMC overall technical quality assurance program for diagnostic x-ray and imaging equipment; [NHPP]



" Task 2: Annual quality assurance testing of all diagnostic x-ray and imaging equipment. See Attachment A for list of equipment; [TJC, NHPP]



" Task 3: Required physics testing of diagnostic x-ray and imaging equipment following repairs that could affect patient dosimetry and/or image quality, as needed; [TJC, NHPP]



" Task 4: Complete structural shielding design plans for the installation of new diagnostic x-ray equipment at OBVAMC. This task is to be completed on an as-needed basis in cases where the structural shielding design plan is not addressed by OBVAMC Engineering Service. [TJC, NHPP]



" Task 5: Complete radiation protection surveys to verify the adequacy of installed shielding for new and/or refurbished rooms or replacement of equipment; [TJC, NHPP]



" Task 6: Initial installation quality assurance testing of all new diagnostic x-ray and imaging equipment on an as needed basis; [NHPP]



" Task 7: Support the OBVAMC Radiation Safety Office by attending the appropriate OBVAMC committee meetings (i.e., Radiation Safety Committee, Image Quality Committee) on a quarterly or as needed basis. The OBVAMC Radiation Safety Office expects the diagnostic medical physicist to be available or prepare a report for these meetings. [TJC]



" Task 8: Support the OBVAMC Radiation Safety Office by reviewing staff dosimetry monitoring results and Nuclear Medicine records kept as required by Nuclear Regulatory Commission. [TJC, NRC]



" Task 9: Written reports signed by the diagnostic medical physicist documenting the shielding design calculations and acceptance testing of the structural shielding. Written reports signed by the diagnostic medical physicist documenting the quality assurance testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment. Each written report will identify the x-ray and/or imaging equipment using the following information at a minimum: OBVAMC EE number and the equipment's location (OBVAMC facility, building, and room number). The Contractor shall provide the physicist report to the RSO within thirty days of completion of the work. The report may be in electronic format. [TJC, NHPP]



" Task 10: Deficiencies or non-conformances which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports must be provided after testing so that OBVAMC will know that equipment can be immediately put into use.



The diagnostic medical physics services will include all x-ray and imaging equipment at OBVAMC. All quality assurance testing reports, shielding designs, and radiation protection surveys shall be submitted to the OBVAMC 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 Overton Brooks VA Medical Center and must be returned to OBVAMC 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 NRC, ACR, NCRP, FDA and TJC requirements and recommendations. All Quality Assurance Tests shall meet or exceed the requirements in the following VHA directives and handbooks:



" VHA Directive 1105.01, Management of Radioactive Materials

" VHA Handbook 1105.02, Nuclear Medicine and Radiation Safety Service

" 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 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 or 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]



Appropriate indices of patient dose, measured by a diagnostic medical physicist at clinically-used technique factors, must 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

" Limited protocol review

o The Diagnostic Medical Physicist must review a selection of the most commonly used protocols. 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:

" 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. 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. PET and Nuclear Medicine



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

" Image uniformity/system uniformity.

" High-contrast resolution/system spatial resolution.

" Low-contrast resolution or detectability

" Artifact evaluation

" SUV analysis



The physics inspection shall conform to the ACR annual 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).



" Intrinsic Uniformity: fail criteria: > 5.0%

" System Uniformity: fail criteria: > 5.0%

" Intrinsic or System Spatial Resolution: fail criteria: > 3.5 mm bars

" Relative Sensitivity: fail criteria: COV > 2.5%

" Energy Resolution: fail criteria: > 12%

" Count Rate Parameters: fail criteria

" Artifact evaluation

" Formatter/Video Display

" Overall System Performance for SPECT

" System Interlocks

" Dose Calibrators (Geometry, if applicable, Accuracy)

" Well Counters

" Thyroid Uptake and Counting System



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 diagnostic medical physicist or medical health physicist. Structural shielding must be installed as necessary to maintain doses to persons in these areas ALARA and within regulatory limits. [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 design of shielding 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. The shielding design calculations, as-built shielding plans, and the report on the acceptance testing of the structural shielding must be kept for the duration of use of the room for x-ray imaging. [VHA Handbook 1105.04]



2.1. Qualifications.

2.1.1. 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 OBVAMC Chief of Staff and approval by the OBVAMC Facility Director. OBVAMC requires a copy of qualifications documents for each individual who will perform work at OBVAMC facility, and OBVAMC must give approval that the individual meets the qualifications before OBVAMC will allow that individual to perform work on x-ray and imaging equipment at OBVAMC.



2.1.2. The Diagnostic Medical Physicist who performs the work at OBVAMC shall meet the following education, certification, and qualification standards:



" Hold a Masters Degree or higher in Medical Physics, Health Physics or a related field.

" Hold current Board Certification by the American Board of Radiology (ABR) or American Board of Medical Physics (ABMP). Appropriate subfield is Diagnostic Medical Physics for ABR certification and Diagnostic Imaging Physics for ABMP certification.

" Licensed by the State of Texas as a Professional Medical Physicist

" Meet all NRC, ACR, FDA and TJC requirements for a qualified diagnostic medical physicist



2.1.3. The Diagnostic Medical Physicist shall have current knowledge, understanding, and recent experience in the following:



" Principles of imaging physics and of radiation protection,

" All current NRC regulations,

" All current FDA regulations,

" Current standards of the ACR and TJC on diagnostic x-ray and imaging equipment,

" Current recommendations of the NCRP and AAMP, including those on medical imaging facility design and shielding,

" The function, clinical uses, and performance specifications of the imaging equipment,

" Current techniques for the calibration and testing of diagnostic x-ray and imaging equipment, including the limitations of the instruments used for testing performance



2.1.4. Contractor employees providing services under the supervision of a Diagnostic Medical Physicist is NOT acceptable (e.g., X-ray technologist) and is NOT permitted per VA contract. A physicist in training or a physicist under a temporary license shall be accompanied by and directly supervised by a Diagnostic Medical Physicist meeting the qualifications stated in Section 2.1.2.



2.2. Required Response Time.



Patient access to health care services at OBVAMC facilities is an absolute high priority. OBVAMC requires the contractor to respond and be present at the OBVAMC facility within 2 business days to provide services for those tasks that have the potential to negatively impact patient access to health care services. These tasks include, but are not limited to, the physics/quality assurance testing of diagnostic x-ray and imaging equipment following repairs that could affect patient dosimetry and/or image quality, the recertification of mammography equipment when required, the initial installation quality assurance testing, and the radiation protection surveys. If the contractor cannot or fails to meet the required response time, then OBVAMC reserves the right to seek medical physics services from other vendors not covered under this contract.



2.3. Subcontracting.

All subcontracting plans shall be submitted as part of the proposal. The contractor shall ensure that the subcontractor meets all the requirements specified in this Statement of Work and all other applicable federal/state regulations and requirements.



2.4. Travel Expenses.

The contractor shall be responsible for travel expenses for all services performed under this contract.





II. Contractor Personnel Security Requirements - Information Systems Access



Upon contract award, all key personnel shall be subject to the appropriate type of background investigation or screening per VA/VHA policy as delineated below, and must receive a favorable adjudication from the local VA facility or VA Security and Investigations Center (SIC) depending on the type of investigation/screening required. This requirement is also applicable to all subcontract personnel. If the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA.



Contract personnel who previously received a favorable adjudication as a result of a Government background investigation or screening may be exempt from this contract requirement provided that they can provide documentation to support the previous adjudication. Proof of previous adjudication must be submitted by the Contractor to VA Contracting Officer. Proof of previous adjudication is subject to verification. Some positions maybe subject to periodic re-investigation/screening.



Position Risk/Sensitivity. For all positions required under this contract, the position risk/sensitivity has been designated as: Low Risk/Non-Sensitive



Prior to completing the required forms, contract personnel should review the attachments entitled Common Errors on NACI Security Questionnaires, Example_SF85, Example_OF306, and General Questions and Answers about OPM background Investigations (see item 3.2 of this contract for these attachments) in order to ensure the forms are properly completed. Please note that incomplete forms will be rejected and could result in a delay of work under the contract.



Once the items requested are received, VA will pre-screen these items for completeness, and forward them to the appropriate party(s) in order to initiate the required background investigation(s) or screening(s) within fourteen (14) calendar days of appointment. Only after the VA Contracting Officer notifies the Contractor that the background investigation(s) or screening(s) was initiated shall the Contractor be authorized to provide services under the contract. As previously stated, if the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA.



The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the contract person from consideration of working under the contract.



Failure to comply with these Contractor personnel security requirements may result in termination of the contract for default.



Information Security

The diagnostic medical physicist working with the contractor may have access to sensitive patient information displayed on the control panel of X-ray equipment. However, contractor owned IT devices (such as laptop computer) shall not interface with any VA internet trusted (i.e., non-public) network. Therefore, the certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required. Contractor shall not print or copy any sensitive patient information.



Attachment A



Room # Manufacturer Equipment Model EE #

4W20 Philips Rad

Digital Detectors Digital Diagnost 30010

4W24 Philips Rad

Digital Detectors Digital Diagnost 27465

4W36 G.E. R&F Precision500D 32480

4W44 G.E. R&F PrecisionRXT 33098

4W44 G.E. Chest Tube PrecisionRXT 33098

4W49 G.E. Digital Chest Diffinium8000 33094

4W37 Toshiba Fluoro Ultimax

41373

4N17 G.E. CT 1 Light Speed + 23670

4W59 G.E. CT 2 Light Speed 30198

Mobile G.E. Radiographic System - Mobile AMX 4+ 30379

Mobile G.E. Radiographic System - Mobile AMX4+ 33812

Mobile G.E. Radiographic System - Mobile AMX 4+ 23077

Mobile G.E. Radiographic System - Mobile AMX 4+ 24155

Surgery GE OEC C-Arm Elite 9900 38082

Surgery GE OEC C-Arm Elite 9900 38737

Surgery GE OEC C-Arm Elite 9900 38080

3W55 Siemens C-ARM Arcadis Varic 42664

5E23 Siemens Cysto

Fluoro UROSKOP 42552

5E28 GE OEC

Pulmonary Elite 9900 43271

6E20

Cardiac Cath Lab GE CATH

Fluoro Innova 3100 35462

BE45 Philips CT Brilliance Big Bore 31068

7N5 Siemens SPECT/CT Symbia T 34586

7N6 Siemens SPECT/CT Symbia T6 40277

7N10 Siemens SPECT Symbia S 34166

7N4 Siemens SPECT E.CAM 28826

Building 42 Siemens PET/CT Biograph 40 36963

Bldg. 57-111 Sirona Dental Helident Plus 40281

Bldg. 57-113 Sirona Dental Helident Plus 40282

Bldg. 57-115 Sirona Dental Helident Plus 40283

Bldg. 57-117 Sirona Dental Helident Plus 40287

Bldg. 57-119 Sirona Dental Helident Plus 40288

Bldg. 57-123 Sirona Dental Helident Plus 40285

Bldg. 57-125 Sirona Dental Helident Plus 40284

Bldg. 57-127 Sirona Dental Helident Plus 40280

Bldg. 57-212 Sirona Dental Helident Plus 40289

Bldg. 57-213 Sirona Dental Helident Plus 40292

Bldg. 57-215 Sirona Dental Helident Plus 40291

Bldg. 57-217 Sirona Dental Helident Plus 40290



Bldg. 57-218 Sirona Dental Helident Plus 40295

Bldg. 57-219 Sirona Dental Helident Plus 40286

Bldg. 57-221 Sirona Dental Helident Plus 40293

Bldg. 57-223 Sirona Dental Helident Plus 40294

Bldg. 57-116 Sirona Dental

Pan 3D Orthophos XG 40279

Bldg. 57-216 Sirona Dental

Pan Orthophos XG 40278