Attachment 1 - PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

Medical Physics Support Services General Requirements The Contractor shall provide one visit (minimum six hours per visit) each quarter. These services shall be on site at the James A. Hayley VA Hospital and Clinics, Tampa, FL, and periodically at the affiliated outpatient clinics.

All services shall be performed on a regularly scheduled basis to be established upon award of contract. Necessary audits, reviews, spot surveys, equipment testing, subcommittee meeting attendance, etc. shall be conducted during these visits in preparation of quarterly reports to be presented at the scheduled James A. Hayley VA Hospital and Clinics (JAHVA) Radiation Safety Committee meeting. The site of scheduled visits (all locations), will be at the discretion of the Contracting Officer’s Representative (COR).

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to the Joint Commission requirements and standards for medical imaging, conduct performance evaluations in accordance with applicable American College of Radiology guidelines, follow relevant VHA Directives, including VHA Directive 1129, and VHA Handbook 1105.04, Fluoroscopy Safety, dated December 14, 2024.

Locations: The services shall be on site at the following locations:

· James A. Haley VA Hospital, 13000 Bruce B. Downs Blvd., Tampa, FL 33612

· Hidden River Primary Care Annex (PCA), 13515 Lake Terrace Lane, Tampa, FL 33637

· Sabal Park Location, 9208 King Palm Dr., Tampa, FL 33619

· Lakeland Outpatient Clinic, 2080 Meadowland Park Blvd, Lakeland, FL 33803

· New Port Richey Outpatient Clinic, 7900 Little Road, New Port Richey, FL 34654

· South Hillsborough Outpatient (SoHi), 12920 Summerfield Crossing Blvd, Riverview, FL 33579

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).

1: Annual review of JAHVA overall Imaging Quality Assurance program for diagnostic imaging equipment. [NHPP] 2: Annual quality assurance testing survey and certification of all diagnostic x- ray and imaging equipment (to include MRI systems). See Attachments A for x-ray tubes and in designated specialties, i.e., nuclear medicine, Radiation Oncology, etc. for a list of equipment. [TJC, NHPP] 3: Recertification of equipment for performance when required due to repair or modification, i.e., x-ray tube replacement, upgrades, etc.

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. The Contractor shall provide two (2) written copies of the physicist report to the RSO and the Chief of Biomedical Services within five days of completion of the work. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR and RSO. Upon completion of the contract a binder containing a hard copy of all of the reports generated under this contract shall be provided to the COR. [TJC, NHPP] 5: Deficiencies or non-conformances which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports must be provided after testing so that JAHVA will know that equipment can be immediately put into use. In the event a deficiency is identified a follow up retesting shall be provided after the deficiency has been corrected by the facility.

6: Dose rate surveys in unrestricted areas adjacent to the radiation areas are to be included during testing and in the final report;

7: A patient exposure chart will be provided for each unit inspected for common projections and procedures;

8: Shielding design approvals for new construction and renovations.

9. Shielding surveys for new construction, modifications and replacement of equipment.

10: Annual quality assurance testing of mammography equipment. [MQSA] 11: Support the JAHVA Radiation Safety Office by membership and attendance on the appropriate JAHVA committee meetings (i.e., Radiation Safety Committee, CT Dose Optimization Committee, Image Quality Committee, etc.) on a quarterly or as needed basis. The JAHVA Radiation Safety Office expects the diagnostic medical physicist to be available to attend these meetings not less than 4 hours per month. [TJC] 12: Provide consultation and final reports for dose estimates calculations for patient, staff and fetal exposures and sentinel event investigations.

13: Emergency time on equipment shall be responded to within 2 hours. The contractor must be able to respond to all locations identified in this PWS within the 2 hours at the same time.

14. The physicist shall perform all work with his own equipment and shall provide a current certificate of calibration with the final report.

The annual quality assurance testing will include all radiology and dental equipment at JAHVA and affiliated outpatient locations. All quality assurance testing reports and mammography equipment performance evaluations reports shall be submitted to the JAHVA 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 James A. Hayley VA Hospital and Clinics (JAHVA) and must be returned to JAHVA at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.”

15. Quality Assurance Testing, 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

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. For mammography, a qualified medical physicist must have state licensure to perform mammography inspections in lieu of board certification and certification must be from the State of Florida. For diagnostic computed tomography (CT), nuclear medicine, PET, or MRI, a qualified medical physicist can meet the following requirements in lieu of board certification:

● A graduate degree in physics, medical physics, biophysics, radiologic physics, medical health physics, or a closely related science or engineering discipline from an accredited college or university

● Formal graduate-level 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 Physicist must document the 3 years of experience for the modality being inspected.

2. Mandatory Services to be Performed

a. The qualified diagnostic medical physicist shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, PET/CT cameras, 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 the service supervisor or 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. A written report of the results shall be provided electronically to the RSO within 5 working days after completion of the inspection. The Contractor shall provide two (2) written copies of the physicist report to the RSO and the Chief of Biomedical Services within five (5) days of completion of the work. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR or RSO.

All imaging equipment (except nuclear medicine cameras and PET equipment, which are quarterly) shall be inspected at least annually, but not to exceed 14 months.

b. 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 the service supervisor or 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. A written report of the results shall be provided to the RSO within 5-working days after completion of the inspection. The Contractor shall provide two (2) written copies of the physicist report to the RSO and the Chief of Biomedical Services within five (5) days of completion of the work. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR or RSO.

c. The qualified diagnostic medical physicist shall perform structural shielding design calculations for any room in which a fluoroscopic imaging system is to be 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] 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] 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] 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 JAHVA Chief of Radiation Safety Service.

d. The qualified diagnostic medical physicist shall perform a full inspection of imaging equipment after repairs or modifications that may affect the radiation output or image quality. The inspection shall be completed within 48 hours after the facility contacts the contractor. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or 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. The Contractor shall provide two (2) written copies of the physicist report to the RSO and the Chief of Biomedical Services within five (5) days of completion of the work. The report shall be placed in a repository with available portal for historical storage.

e. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, i.e., safety training. The Contractor shall provide and carry a personal telephonic pager or cell phone and respond to JAHVA by telephone within 10 minutes for consultations and when needed shall be on-site within (1) hour of being notified during normal business hours (0800 to1630 hrs. Monday through Friday) for emergency procedures. (Contractor will be compensated for emergency visits separate from this contract.)

f. The qualified diagnostic medical physicist shall review CT protocols at least annually.

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, and, for dental units, NCRP Report No. 145, 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. A written report of the shielding survey shall be provided to the RSO within 5 workings days after the shielding survey has been completed.

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. A written report of the results shall be provided to the RSO within 5 working days after performing the inspection.

i. The qualified diagnostic medical physicist shall perform a follow-up inspection to verify compliance of any necessary corrective action performed to correct deficiencies found.

j. The qualified therapeutic medical physicist shall provide medical physicist peer review for radiation oncology service at least quarterly, following ACR guidelines and American Association of Physicists in Medicine (AAPM) TG 103 report. .

k. The qualified diagnostic medical physicist shall perform annual fluoroscopy inspection of all lead protective garments and devices. Personal lead protective apparel shall be inspected for their integrity of radiation protection and documented by the surveyor. Also, as requested all x-ray rooms shall be evaluated for adequate operator barrier protection and to assure that proper warning signs and labels are displayed.

3. Equipment Inspections The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below in Appendix A and any replacement or addition to list. 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.

Contractor shall perform Quarterly Quality Control Reviews and Performance Evaluations of x-ray generating equipment during the first week of February, May, and August of each contract year. The annual review and evaluation will be scheduled the first week of October. This schedule shall be adhered to unless an alternate schedule is agreed upon in advance by the Contracting Officer and the contractor. The content of the quarterly reviews is described as follows. 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. 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] The qualified medical physicist shall provide consultation and guidance for patient exposure exceeding thresholds. Dose tracking reports shall be authenticated and results included in a written report for the quarterly JAHVA Radiation Safety Committee meeting.

B. Computed Radiography (CR) and Digital Radiography (DR) Physics inspections of CR and 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 CR and 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.

C. CT Scanners, including CBCT for Linear Accelerators The physics inspection shall conform to the 2012 or current year ACR Computed Tomography Quality Control Manual. 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 Volume 1 Dental Facilities July 2001. The performance of dental x-ray inspections shall be 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. Quality Assurance Testing: 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 PWS, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this PWS.

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 All video monitors utilized for primary diagnosis and clinical review of medical images shall be evaluated as follows: Diagnostic Review Workstations (up to 40) shall be evaluated quarterly.

Each monitor shall be evaluated for DICOM Part 14 Gray Scale compliance (presented graphically as normalized JND values); uniformity of screen luminance at 50% & 100% digital drive levels. Artifacts (stuck pixels [black or white], pen marks, etc.), geometric accuracy (pin cushioning, barreling, aspect ratio) and a general visual inspection. A full report of the unit performance shall be provided to the RSO within 5 days of completion of evaluation.

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.

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

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

b. Review the black-white transition.

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

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

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

5. 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 are located.

E. Mammography The qualified diagnostic medical physicist inspecting mammography equipment must meet the qualifications outlined in the MQSA and shall provide the facility with up-to-date documentation demonstrating the qualified diagnostic medical physicist is MQSA qualified. Inspections of mammography equipment must comply with the latest requirements posted on the ACR Web site for the manufacturer of the digital mammography unit being inspected. Inspection items may include:

(1) Mammographic Unit Assembly Evaluation.

(2) Collimation assessment.

(3) Artifact evaluation.

(4) kVp accuracy and reproducibility.

(5) Beam quality assessment – HVL measurements.

(6) Evaluation of system resolution.

(7) Automatic Exposure Control (AEC) function performance .

(8) Breast entrance exposure, AEC reproducibility, and average glandular dose.

(9) Radiation output rate.

(10) Phantom image quality evaluation.

(11) Signal–to–noise ratio and contrast–to noise ratio measurements.

(12) View box luminance and room illuminance.

(13) Review Work Station (RWS) tests.

F. MRI

The physics inspection shall conform to the latest edition of the ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI scanner shall be evaluated at least annually. Current inventory is six (6) MRI units. 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 G. Nuclear Medicine Contractor shall be responsible to:

a. Review service records to ensure compliance in accordance with Radioactive Materials Permit. (Quarterly)

b. Review service records to ensure that all radiopharmaceuticals administered to patients are in agreement with prescribed doses, receipt, storage, preparation, and disposal of radioactive materials. Contractor shall also review all records, including equipment quality control pertaining to, dose administration, and wipe testing and area surveys. (Quarterly)

c. Monitor absorbed radiation in individual patients as requested by Nuclear Medicine physicians. (Quarterly)

d. Perform an annual audit of Quality Management Program (including all Radiotherapy) and monitor ALARA programs.

e. Review and provide procedures to be followed in the event of radioactive contamination of the environment, patients, personnel, or equipment.

f. Calculate spilled gas clearance time based upon semi-annual airflow measurements made by engineering. Evaluate performance of Xenon delivery system. (Quarterly).

g. Perform annual calibration of Captus 3000 Thyroid Uptake and Well Counter Systems for the multi-channel analyzer/thyroid uptake units, and Atom Lab well counters. Perform geometry testing of dose calibrators, when needed.

h. Perform sealed source leak test and provide written report (Quarterly)

i. All of the above items shall be addressed in a written report, which shall be presented and reviewed at the quarterly JAHVA Radiation Safety Committee meeting held in the 4th week of November, February, May and August.

j. Assist with consultation license renewals and amendments for VHA and NRC submission.

H. PET/CT

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 Item C for CT scanners above. Current inventory of one (1) PET/CT unit. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Uniformity.

(2) Spatial resolution.

(3) SUV analysis.

I. Nuclear Medicine 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. Current inventory of six (6) gamma cameras. 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, if applicable, Accuracy)

(11) Thyroid Uptake and Counting Systems J. Radioactive Waste Contractor shall be responsible to:

a. Monitor and review all records pertaining to the preparation and shipment of radioactive waste.

b. Monitor and review all records pertaining to area surveys, wipe testing, receipt, storage, and disposal of all radioactive material in accordance with all NRC regulations.

c. All of the above items shall be addressed in a written report, which shall be presented to and reviewed at the JAHVA Radiation Safety Committee meeting.

K. Display Monitors or Acquisition 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, PET, CT, and MRI units shall be tested.

L. Contractor Personnel Security Requirements - Information Systems Access Upon contract award, all personnel with access to the facility 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.

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 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.

The current inventory of x-ray producing equipment is listed below. The Performance Work Statement will be amended as necessary to reflect new or modified equipment or changes in regulatory requirements and expectations.

GENERAL INFORMATION:

M. HOURS OF OPERATION:

Work will be done at the James A. Hayley VA Hospital and Clinics, Tampa, FL, and periodically at the affiliated outpatient clinics, and may be accomplished as scheduled in advance with the COR, during normal business hours: 7:00 AM to 4:30 PM, Monday through Friday, excluding National Holidays:

N. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

This QASP was developed to evaluate contractor actions while implementing this PWS. It is designed to provide an effective method of monitoring contractor performance for each listed objective in the PWS and on the Service Delivery Summary (SDS) table below. The QASP provides a systematic method to evaluate the services the contractor is required to furnish.

This QASP is based on the premise that the Government desires to maintain a quality standard in the operation of the systems to be serviced under this agreement and to provide the service is the best means of achieving that objective. The Contractor, not the Government, is responsible for management & quality control actions to meet the terms of the contract. The Government’s role is quality assurance to ensure contract standards are achieved.

Factor # Performance Criteria Performance Standard Max Allowable Deviations Method – Type of Surveillance Deficiencies with unsafe conditions Any non-conformances/deficiencies representing unsafe conditions with potential to adversely impact patients or staff shall be reported to the RSO IMMEDIATELY upon discovery Must meet standard 100% Monitor through COR & RSO Written Reports Reports shall meet the criteria as specified in Section 2 (Mandatory Services To Be Performed), and shall contain the requested data noted. This includes…

• Compliance Inspections

• Acceptance Testing

• Shielding Design Calculations

• Full Inspections after modifications or repairs

• QA Program Reviews & Consultation

• Survey Reports 2 occurrences per year Monitor through COR Equipment Inspections

• Nuclear Medicine Unit inspections shall be conducted Quarterly

• All other Imaging equipment inspections (except for the category noted above), shall be conducted Annually

• Will ensure the imaging equipment’s compliance with applicable Federal regulations and ACR recommendations; & shall include monitoring the basic performance characteristics of each modality as specified in the PWS

• Annual inspection shall include testing of image acquisition display monitors to include maximum & minimum luminance, luminance uniformity, resolution, & spatial accuracy

• Full inspection will be performed within 48 hours after vendor is contacted regarding modifications or repairs to imaging equipment that may affect the radiation output or Must meet standard 100% Monitor through COR Factor # Performance Criteria Performance Standard Max Allowable Deviations Method – Type of Surveillance image quality Patient Exposure Chart A patient exposure chart for common projections & procedures shall be provided for each unit inspected Must meet standard 100% Monitor through COR CT Protocols CT Protocols shall be reviewed at least annually Must meet standard 100% Monitor through COR Radiation Safety Committee Meetings Support the JAHVA Radiation Safety Office by membership and attendance on the appropriate JAHVA committee meetings (i.e., Radiation Safety Committee, CT Dose Optimization Committee, Image Quality Committee, etc.) on a quarterly or as needed basis.

Must meet standard 100% Monitor through COR Dose Estimate Calculations Will provide consultation and final reports for dose estimate calculations for patients, staff, and fetal exposures, & sentinel event investigations Must meet standard 100% Monitor through COR O. SURVEILLANCE: The government QA (COR & RSO) will evaluate the objectives through periodic inspections during the service.

1. STANDARD: Standards must be met 100%. The Contractor shall perform all work required in a satisfactory manner in accordance with the appropriate PWS paragraph above. The QA shall not consider the services complete until all deficiencies have been corrected.

2. PROCEDURES: The COR & RSO will inspect all performance objectives to ensure Contractor compliance with the PWS. If inspection indicates unacceptable performance, notify the Contractor of the deficiencies. Contractor shall be given adequate time to correct the unacceptable performance. If deficiencies are not corrected timely, the COR shall notify the Contracting Officer for action.

P. EMERGENCY SERVICES - In the event the Emergency Services are required, the COR will notify the contractor. A Firm Fixed Price proposal shall be submitted to the Contracting Officer within 24 hours to negotiate, definitized, and complete based on the labor mix table attached. The proposal shall include details as to the extent of the emergency to enable the Government to evaluate the proposal and eventual price. At a minimum, each proposal shall include:

1. Brief description of the emergency and why it is required

2. Categorical Labor Hours breakdown to accomplish required effort (based on labor mix, pre-negotiated in tables below)

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

c. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

d. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as ( low ) risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The web site which provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

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

VA INFORMATION CUSTODIAL LANGUAGE:

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic…