Medical Physics Contract SOW 2024 .docx

DRAFT

Statement of Work Medical Physicist Services

I. Description of Services.

Scope of Work The Contractor shall provide all labor, material, supplies, equipment, transportation, software and qualified personnel, to provide medical physicist services in support of the Veterans Affairs Northern California Health Care System, (VA NCHCS) Radiation Safety Program, headquartered at the VA Medical Center Sacramento at Mather, California. Satellite offices are located at the VA Outpatient Clinic in Martinez, Redding, Oakland, Mare Island and McClellan California. All work is performed on site at the VA facilities listed in Appendix 2.

Qualifications Prior to commencing work all contractor employees shall meet certain criteria to perform work under this contract as a Medical Physicist. Qualification documents must be submitted to the RSO or his/her designee and be approved. All qualifications are subject to review by the VA NCHCS Chief of Staff and approval by the VA NCHCS Facility Director.

1. Medical Physicists shall meet the following education, certification, and qualification standards:

1. Hold a Master’s Degree in Medical Physics, Health Physics or a related field.

2. Hold current Board Certification in Diagnostic Radiological Physics by the American Board of Radiology and or American Board of Medical Physics.

3. Meet ACR/FDA qualifications for mammography medical physicist.

4. Medical physicist should have experience in:

a) Decommissioning a NRC licensed medical facility

b) All current NRC regulations, VA NHPP Best Practices (1105.04 Fluoroscopy Safety Program), and the State of California Department of Health Services Radiological Health Branch Radioactive Materials license for sharing agreement.

c) CT Optimization

d) Consulting in NRC license amendments related to the medical use of radiation.

e) Calibration and testing of diagnostic x-ray and Nuclear Medicine equipment.

f) As a consultant to a medical facility licensed by the NRC to perform nuclear medicine and biomedical research.

2. Medical Physicist duties shall not be reassigned to a Technologist or any other individual without written approval by the VA Radiation Safety Officer or his/her designee.

3. Medical Physicist must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated July 6, 2012. Contractor shall comply with radiation protection standards 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facticity radiation workers or patients to the Radiation Safety Officer (RSO).

General Requirements

1. Contractor shall perform Quarterly, Semi-Annual and Annual QC Testing on existing Nuclear Medicine and Diagnostic x-ray equipment (Radiographic, Fluoroscopic, PET/CT cameras, Mammographic, CT, DR, CR reader(s), and MRI safety check) to meet the requirements of the VA NCHCS Radiation Safety Program.

Reference Appendix 4 for a list of equipment to be tested.

2. Additional testing is also required as follows:

a. Acceptance testing of new devices, usually 1 per year.

b. Full inspection of repaired or adjusted equipment that may affect the radiation output or image quality

c. Testing of each replacement X-ray tube prior to patient use.

d. Testing of diagnostic monitors used by Radiologists and Technologists for patient imaging at external contract facility.

3. Contractor is to provide written reports of surveys and test results in a timely manner.

4. Contractor will respond promptly to any discrepancies found from external inspections. Provide written response to outside agencies when applicable.

5. The qualified medical physicist shall provide consultation for additional services as needed, i.e., safety training, SNM annual phantoms and medical events involving radiation exposure.

6. The qualified medical physicist shall attend the Radiation Safety Meeting, reviewing minutes prior to the meeting and afterwards.

7. The qualified medical physicist shall review al Radiation Safety Policies and Procedures with attention to compliance with regulations, NHPP, JACHO and NRC.

8. Contractor is to submit a list of key personnel with the offer. Define each individual’s education, certification and licensure.

Scheduling and Response Times

1. All quarterly, semi-annual, and annual tests will be scheduled in advance.

1. All testing on new devices or repaired or adjusted equipment requires a four (4) hour response time, in order to maintain functionality and minimize the effect on patient care.

1. A written report of the results shall be provided to the service supervisor or RSO within Thirty (30) working days after completion of the inspection.

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

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

Estimated Quantities and Locations

Advanced Imaging Devices / Equipment (CT, PET/CT, Mammography, MRI, Nuclear Medicine Audits)

Rad/Fluoro/Tomo Tubes (X-Ray, Digital, Fluoro, C-Arm)

Minor Radiographic Tubes (Dental, Ultrasound, DEXA)

* Patient dose evaluation is included

1. VA Outpatient Clinic, 150 Muir Road, Martinez, CA

2. VA Medical Center Sacramento, 10535 Hospital Way, Mather, CA

3. Contra Costa Regional Medical Center (CCRMC), 2300 Alhambra Blvd, Martinez, CA

1. Redding Outpatient Clinic, 351 Hartnell Ave, Redding, CA

1. Chico Outpatient Clinic, 280 Cohasset Road, Chico, CA

1. Oakland Outpatient Clinic, 2221 Martin Luther King Blvd, Oakland, CA

1. Mare Island Outpatient Clinic, Walnut Ave, Bldg. 201, Mare Island, Vallejo, CA

1. McClellan VA Outpatient Clinic, 5342 Dudley Blvd, McClellan Park, CA 95652

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

1. Integrity of unit assembly.

2. Collimation and radiation beam alignment.

3. Fluoroscopic system 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. Maximum output for all clinically used settings.

14. Image receptor entrance exposure.

15. Equipment radiation safety functions.

16. Patient dose monitoring system calibration.

17. Video and digital monitor performance.

18. Digital image receptor performance.

19. Grids used with portable x-ray units shall be imaged for uniformity.

B. Computed Radiography (CR) and Digital Radiography (DR) Physics inspections of CR and DR equipment shall comply with 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

The physics inspection shall conform to the 2012 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. Review CT Optimization at least annually

3. Scout Prescription and Alignment Light Accuracy

4. Image thickness – Axial Mode

5. Table Travel Accuracy

6. Radiation Beam Width

7. Low-Contrast Performance

8. Spatial Resolution

9. CT Number Accuracy

10. Artifact Evaluation

11. CT Uniformity

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

13. 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 each dental x-ray shall be annually or every 2 years. 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

8. Technique Chart Evaluation

9. Image uniformity (artifact evaluation)

E. Mammography

The qualified diagnostic medical physicist inspection of mammography equipment must meet the qualifications outline in the Mammography Quality Standards Act (MQSA) and shall provide the facility with up to date documentation demonstration the qualified diagnostic medical physicist is MQSA qualified. Inspections of mammography equipment must comply with the latest requirements posted on the ACR website 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 ration measurements

12. View box luminance and room luminance

13. Review workstation (RWS) tests

F. MRI

The physics inspection shall conform to the 2004 ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI scanner shall be annually. This evaluation should include, but not be limited to, the following tests (as applicable):

1. Magnetic field homogeneity

2. Geometric accuracy

3. Inter-slice RF interference

4. Slice position accuracy

5. High contrast resolution

6. RF coil performance

a) Volume coils’ signal to noise ratio

b) Volume coils’ image uniformity

c) Volume coils’ ghosting ratio

d) Phased array coils’ signal to noise ratio

e) Surface coils’ signal to noise ratio

7. Slices 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. PET

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 above. This evaluation should include, but not be limited to, the following tests (as applicable):

1. Uniformity

2. Spatial resolution

3. SUV analysis

H. 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 quarter testing as outlined by the ACR. This evaluation should include, but not be limited to, the following tests (as applicable):

1. Intrinsic Uniformity: fail criteria: > 5.0%

2. System Uniformity: fail criteria: > 5.0%

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

4. Relative Sensitivity: fail criteria: COV> 2.5%

5. Energy Resolution: fail criteria: > 12%

6. Count Rate Parameters: fail criteria:

7. Overall System Performance for SPECT

8. System Interlocks

9. Dose Calibrators (Geometry, Accuracy)

10. Thyroid Uptake and Counting System

I. Ultrasound

The physics inspection shall conform to the ACR performance tests for ultrasound. On an ongoing basis (at least semiannually), the following tests should be done for each ultrasound unit. Testing should be done using two transducers commonly used with any unit employing more than one transducer. Data should be taken from testing of the transducers which are used for the most frequently occurring examination(s) at the site. It is recommended that these be of different scan formats such as one linear (or curvilinear array), and one sector (mechanical, phased, or vector).

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

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

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

3. Electrical and Mechanical Safety and Cleanliness

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

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

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

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

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

Required Test Equipment

The same test image should be used each time.

J. Display Monitors

The physics inspection shall conform to the AAPM On-line Report No. 03, Assessment of Display Perform for Medical Imaging Systems. The performance of each display monitor shall be evaluated initially, acceptance testing, and at least annually thereafter. This evaluation should include, but not be limited to, the following tests (as applicable):

Acceptance testing (Table 7 from AAPM On-line Report No. 03) and (Table 8c form AAPM On-line Report No. 03)

1. Geometric distortions

2. Reflection

3. Luminance response

4. Luminance dependencies

5. Resolution

6. Noise

7. Veiling glare

8. Chromaticity

Equipment

1. Government Furnished Equipment and Software:

The Government will provide the following

1. Radiation detection devices, dose calibrators

2. ACR mammography accreditation phantoms,

3. CT image quality phantoms and ACNP-SNM Nuclear Medicine Accreditation phantoms.

4. SNM Annual Nuclear Medicine Phantom

2. Contractor Furnished Equipment and Software:

The Contractor shall provide all other equipment and software not specifically cited above to perform the requirements of this contract. At a minimum:

1. Testing all diagnostic x-ray equipment

2. CT scanner

3. Digital mammography

4. Nuclear Medicine

5. PET/CT

6. All phantoms for CT (head and body), Radiography, Ultrasound, and Mammography

Miscellaneous Evaluations (Radiographic, Fluoroscopic, CT, PET/CT, Nuclear Medicine)

1. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replacement, 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 five (5) workings days after the shielding survey has been completed.

1. The qualified medical physicist shall assist in the development of a comprehensive technical quality assurance program (QA) (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.

1. The qualified diagnostic medical physicist shall follow up on any discrepancies found on previous inspections including external i.e., ACR, JACHO, NRC, IOG, VORP or internal audits.

1. Travel/Transportation

1. The Contractor shall provide all transportation necessary to perform the requirements of this contract, if included in services.

2. The majority of the work will be accomplished at the Martinez and Mather however, due to the nature of the services required; the Contractor shall be required to travel to all of the sites of Northern California Health Care System.

3. All travel related costs, including lodging or any other miscellaneous costs shall be the sole responsibility of the contractor and shall be included in the finished fixed unit price on the Price Schedule.

4. The Contractor shall not charge the hourly rate for services while in transit to any of the sites.

Regulations

1. The Contractor shall perform services in accordance with VA NHPP and NRC regulations at all locations with the exception of the CCRMC. The CCRMC is licensed by the State of California Department of Health Services Radiological Health Branch. At CCRMC the VA acts as Radiation Safety Consultant for the portion of the facility operated by the VA. Within VA NCHCS facilities, NRC regulations apply. The Contractor shall apply the appropriate procedures depending upon the location where the services are being provided.

2. The average frequency of utilization of the medical physicist will be one to two visits per month during time of major facility activation the frequency might increase to three visits per month by the Medical Physicist.

Evaluation Criteria

Technical Expertise: All offers’ must submit the following to be considered for award of this contract:

1. A list of key personnel, displaying the applicable certifications and licenses required to perform these services. The list should identify personnel that will be specifically dedicated to this contract.

1. Evidence of the necessary technical capabilities and adequate resources to successfully meet all of the VA requirements in the required time.

Past Performance: All offers’ must submit at least three (3) references from contracts with a similar scope of work. References should include the organization, point of contact, phone number, and e-mail address.

9. RECORDS MANAGEMENT LANGUAGE

Records Management Language for Contracts Required The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.