36C25524Q0477 0002_JB.pdf

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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1 11

07/31/2024

589-24-3-2618-0019 None

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

To all Offerors/Bidders 36C25524Q0477

07-24-2024 X

X X

X 1

Performance Testing Services for Imaging Equipment to include: CT, MRI, Nuclear Medicine, SPECT/CT, PET/CT, and Fluoroscopy at the Eastern Kansas Health Care System. The purpose of this amendment is to:

1. Correct a date in the PWS - Annual testing shall take place in August 2024, not August 2025. Please see attached updated PWS

Jessica D. Barton Contracting Officer

Performance Work Statement (PWS)

Physicist Testing Services

Part I: General Information The Eastern Kansas Health Care System (Leavenworth and Topeka VAMC) has a requirement for Performance Testing Services to be completed by a qualified Diagnostic Medical Physicist (DMP) with American Board of Radiology (ABR) Certification for Imaging Equipment Listed in Attachment 1. The equipment includes, but is not limited to:

CT, MRI, Nuclear Medicine SPECT/CT, PET/CT, Radiology and Fluoroscopy.

Part II: Scope of Work

• The annual testing schedule will be coordinated with the Contracting Officers Representative (COR), Radiation Safety Officer (RSO) and HTM Office. The Contractor shall provide assistance with the Radiation Safety Program, records documentation pertaining to equipment inspections and exposure reports, computed tomography (CT) protocol optimization, Fluoroscopy protocol optimization, radiation protection shielding calculation and room design, inspection of radiation protection shielding, 24 hours per day 7 days per week telephone consulting services, performance testing of all new or relocated imaging equipment prior to first clinical use, and STAT or URGENT testing.

This service must meet requirements of the National Health Physics Program, Veterans Health Administration, Joint Commission, and the American College of Radiology requirements as listed in Part II of this document.

• Annual Services to Be Performed:

o The contractor shall provide the below listed services for the Eastern Kansas

Healthcare Systems (EKHCS) campuses, travel expenses, tools, test equipment and other incidentals necessary to test, survey or certify the listed equipment to the standards as outlined in the services sections below.

o This requirement is a base plus one-year contract with a certified physicist.

Physics inspections shall include testing for all radiation producing equipment at Eastern Kansas. This shall also include quarterly nuclear medicine audits for all facility hot labs. Testing shall include current list as well as testing taking place on repaired equipment and newly received equipment.

o The contractor shall perform American College of Radiology (ACR) Performance Testing on the 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) requirements. All required testing equipment shall be provided by the contractor. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Radiation Safety Officer (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 3 working days after completion of the inspection. All imaging equipment shall be inspected at least annually, not to exceed 13 months. QC testing performed by facility personnel shall be reviewed by the Contractor.

o The contractor shall perform, upon request, performance testing of all new or relocated imaging equipment prior to first clinical use. The performance testing shall comply with the most recent ACR or MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the RSO prior to the contractor 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 taken out of service and reported to the RSO immediately upon discovery. A written report of the results shall be provided to the RSO within 3 working days after completion of the inspection.

o The Contractor 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 1 working days after the facility contacts the physicist, prior to any patient care taking place. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the RSO prior to the contractor 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 taken out of service and reported to the RSO immediately upon discovery. A written report of the results shall be provided to the RSO within 3 working days after completion of the inspection.

o Annual testing shall take place August 2024.

o The Contractor shall provide consultation for additional services for safety training (as needed) and shielding integrity surveys.

o The Contractor shall review CT and fluoroscopy protocols and include dose reduction techniques where applicable at least annually.

o The Contractor shall provide shielding design calculations, upon request for each new, replaced, or relocated x-ray imaging system. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147 (or the most recent version), and, for dental units, NCRP Report No. 145 (or the most recent version) and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic medical physicist shall perform a shielding survey to verify the structural shielding was installed per the shielding design report and complies with the design goals. A written report of the shielding survey shall be provided to the RSO within 3 workings days after the shielding survey has been completed.

o The Contractor shall assist on-site QM Technologist 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 the most current ACR recommendations, for all modalities.

o The annual performance evaluation conducted by the contractor shall include testing of image acquisition display monitors for maximum and minimum luminance, luminance uniformity, resolution, and spatial accuracy. The image acquisition display monitors including, but not limited to nuclear medicine, PET, CT, and MRI shall be tested.

Additional Services:

o Provide 24/7 Physicist Telephone/Fax Consultation for the following:

a. Assist with the Eastern Kansas VAMC Radiation Safety program and ensure that required Federal records are properly documented and maintained.

b. Assist in monitoring patient radiation doses during procedures.

c. Assist in estimating fetal radiation dose calculations using an ACR

Certified Diagnostic Physicist.

d. Assist during scheduled procedures when requested and provide instruction to hospital personnel as required by hospital accreditation agencies.

e. Assist with preparing over-exposure reports for personnel radiation exposures.

f. Assist with a review of incidents involving diagnostic x-ray equipment cause and actions taken.

o Services to be provided as needed:

a. Inspect/evaluate additional imaging equipment as necessary due to equipment.

b. Acquisition and or repair/replacement of existing equipment up to 10 times per year.

c. Design and calculation of radiation protection shielding up to 5 times per year.

d. Inspection of radiation protection shielding up to 5 times per year.

e. Computed Tomography (CT) protocol optimization annually/scanner up to

3 scanners.

f. Fluoroscopy protocol optimization annually/scanner up to 3 scanners.

Part III: Supporting Information:

• Information Security Contractor shall adhere to HIPPA/Privacy rules required by

VAMC, reports violations per VA Directive 6500.6.

• Response Time Contractor shall respond by phone within two hours when services are requested. Contractor shall be on-site for equipment inspection within 3 hours of notification for downtime that effects direct patient care.

• Place of Performance The place of performance will be at the VA Eastern Kansas Department of Veterans Affairs with campuses located at the Dwight D.

Eisenhower VA Medical Center, 4101 S. 4th St Traffic way, Leavenworth, KS and one campus located at Colmery- O’ Neil VA Medical Center, 2200 Gage Blvd, Topeka, KS.

• Hours of Work o All routine services must be performed between the hours of 7:00AM and

3:00PM Monday through Friday. Services may require STAT or URGENT response times. In the event a piece of radiology equipment experiences repairs a physicist will be required to test the equipment prior to patient care resuming.

o Normal business hours vary by department/section. Service shall be coordinated as necessary to reduce impact to patient care.

o Emergency hours of work are defined as 24hours per dayx7days a weekx365days a year. Non-emergent hours of work for are defined as Monday through Friday from 7 a.m. to 3:00 p.m. EST, excluding federal holidays, or as otherwise arranged with the Contracting Officer Representative (COR).

Telephone consultations shall be available 24hours per day.

o The ten holidays observed by the Federal Government are New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday.

o Work performed outside of normal working hours of coverage must be requested by the Contracting Officer's Representative, RSO or HTM Office.

• Period of Performance This requirement will be for a 1-year PoP, beginning on the date of award.

• Qualifications of Key Personnel o American Board of Radiology Certified Diagnostic Medical Physicists.

• Contract Specifics o All services for this contract must meet manufacturers’ performance and technical specifications, ISO standards, State, Federal, FDA device certification and other specifications that may apply such as NRC, NHHP and ACR regulations and guidelines, Joint Commission (JC), and VA Regulations. Also, Contractor shall provide hardcopy proof, upon request by COR, that on-site servicing contracting entities are qualified and certified Medical Physicists.

Contractor service representative shall report to the RSO in Topeka (Laura Knox), ARSO in Leavenworth (Hilary Klein) or the HTM Supervisor (Luke Bowers) prior to beginning services.

o The contractors shall not have access to the VISTA computer network, nor shall the contractor access any PHI and or PII (electronic or hardcopy) at any time.

o The contractor shall ONLY respond to service calls placed from COR or designee. The Contracting Officer Representative (COR) for this contract is Laura Knox (facility RSO), her office phone number is (785)350-3111 ext 52595 and her email address is Laura.Knox@va.gov or, designee, Luke Bowers, HTM Supervisor, VAEKHCS, his office phone number is (913)547-5227 and his email address is Luke.Bowers@va.gov. Contractor shall respond to COR contact by telephone within two hours and be on-site for services within three hours unless otherwise specifically required by specific date when on-site services are required.

o Contractor shall not perform any service that will result in additional charges without prior approval from the VISN 15 Contracting Officer.

o All contractor personnel must report to the COR or, the Healthcare Technology Management Department to sign in before any work is performed on the premises of the VA EKHCS campuses, and to sign out after completion of assignment. The contractor must furnish a detailed field service report, or equivalent, showing work completed to maintain operating efficiency of the equipment. Payment will be withheld pending receipt of this report.

o There is a potential for exposure to blood borne or other infectious material with equipment throughout the hospital. All maintenance persons must use the “Universal Precautions” (i.e. decontamination of medical equipment, wearing mailto:Laura.Knox@va.gov mailto:Luke.Bowers@va.gov protective gloves, aprons, and goggles) during cleaning and maintenance/repair procedures required by this contract.

Services Section A

MEDICAL PHYSICS SERVICES FOR NUCEARL MEDICINE AND PET/CT

(Annual Visit and Quarterly Visit)

The services listed below will be provided by a qualified Medical Physicist. The physicist will visit the facility for whatever length of time is necessary for the performance of these services. The tests will be performed to help ensure compliance with applicable State, Federal, NRC, Joint Commission, NHHP, and ACR regulations and guidelines.

All quarterly requirements are to be completed in the months of November, February, May, and August. All semi-annually requirements shall be completed with quarterly requirements in the month of November and May. All annual requirements shall be completed with quarterly requirements in the month of August.

1. Calibration of the following instrumentation:

a. Quarterly calibration of the dose calibrator for linearity and accuracy. Geometrical variation will be done after repair or replacement.

b. Quarterly E-dial resolution checks (full width half maximum) and Chi-square measurements on all probe devices and well counters.

c. Quarterly review of daily floods and weekly bar phantom resolution checks.

d. Annual efficiency determination for well/uptake systems used for routine wipe test evaluations.

2. Quarterly checks of all records and surveys (dosimeters, disposition records, waste disposal, floods, etc.) as required for compliance with federal, state, and NRC regulations. Quarterly reports will be done in November, February, May and August of each year.

3. Quarterly review of the Quality Management program for the completeness accuracy.

Annual summary to be presented to the Radiation Safety Committee.

4. Provide annual ALARA summary for the RSO. Annual summary will be presented to the Radiation Safety Committee.

5. Provide annual review of Radiation Safety Program.

6. Perform quarterly leak test and inventories for all sealed sources.

7. Provide health physics support in all phases of the radiation protection as required by

10D-91

8. Provide dosimetry/fetal dose calculations.

9. Annual review of Computed Tomography (CT) protocols to ensure they adhere to current standards of practice.

Annual Camera (SPECT/CT and PET/CT) Evaluation Test for ACR Accreditation

The requirements of the ACR for compliance with the Quality Control Program required of ACR accredited facilities includes the following items as tests which must be performed at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

Annual requirements shall be complete in the Month of August.

1. Intrinsic Uniformity

2. System Uniformity for all collimators

3. Intrinsic or system spatial resolution

4. SUV Analysis

5. System sensitivity

6. Energy resolution

7. Count Rate parameters

8. Image printers/video display

9. Overall system performance for SPECT and PET systems

10. System interlocks

11. Dose calibrators

12. Thyroid uptakes and counting systems

If the camera accreditation is limited to planar imaging only the overall SPECT and PET performance does not apply.

The last two items on this list are checked quarterly and the report of the last evaluation is simply added to the report of the camera evaluation.

The test listed here for the camera evaluation must be performed on each detector on the system.

These are the same tests that must be performed for application for ACR accreditation or renewal of the ACR accreditation (every three years).

Services Section B

MEDICAL PHYSICS SERVICES FOR DIAGNOSTIC RADIOGRAPHIC AND

FLUOROSCOPIC EQUIPMENT

(Annual Visit)

The services below will be provided by a qualified Medical Physicist on an annual basis. The physicist will visit the facility for whatever length of time is necessary for the performance of these services, BRH, NCRP, Joint Commission, and state and federal guidelines will be used in the performance of these tests. This evaluation should include, but not be limited to, the following tests (as applicable).

1. Determine x-ray beam, light beam alignment for radiographic and Fluoroscopy units.

2. Measure the tabletop or patient entrance dose on all Fluoroscopy units. Measure photo-timed spot film exposure when possible.

3. Visual inspection of cables, operator’s booth requirements, meters, and switches.

4. Determine the half-value layer on all radiographic and Fluoroscopy tubes.

5. Perform mAs linearity and exposure/timer reproducibility checks on radiographic units. Photo-timed reproducibility will be checked on those units equipped with photo-timing.

6. Measure the exposure in air under fixed and photo-timed conditions where possible on all radiographic equipment.

7. Perform kVp calibration check using non-invasive measurements.

8. Determine Fluoro resolution.

9. C-arm units will be checked in all Fluoroscopy modes. Maximum output for all clinically used settings.

10. Integrity of unit assembly.

11. Fluoroscopic system resolution.

12. Automatic exposure control system performance.

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

14. Image artifacts.

15. Fluoroscopic phantom image quality.

16. kVp accuracy and reproducibility.

17. Linearity of exposure versus mA or mAs.

18. Exposure reproducibility.

19. Timer accuracy.

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

21. Image receptor entrance exposure.

22. Equipment radiation safety functions.

23. Patient dose monitoring system calibration.

24. Video and digital monitor performance.

25. Digital image receptor performance.

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

Services Section C

MEDICAL PHYSICS SERVICES FOR CT UNITS

basis. The tests will be performed to help ensure compliance with applicable State, Federal, and Joint Commission and ACR regulations and guidelines. The physicist will visit the facility for whatever length of time is necessary for the performance of these tests.

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

1. Measure CT dose profile for all available beam profile widths.

2. Review and signature of all CT protocols.

3. Calculate CT dose indexes for the common exams performed on the scanner.

4. Determine the high and low contrast resolution for the facility’s adult head, Adult

Abdomen, Pediatric Head, Pediatric Abdomen and High-Resolution Chest protocols.

5. Evaluate image uniformity for any rings or artifacts.

6. Measure CT numbers for water, high contrast insert, and low contrast insert to monitor image noise.

7. Measure slice thickness accuracy for all available slice thicknesses.

8. Check internal and external light positioning accuracy.

9. Table Travel Accuracy.

10. Check slide location/light alignment.

11. Perform a radiation scatter survey inside the scanner room, inside control booth and in the surrounding area to ensure the radiation safety of personnel in the area.

12. Review the facility quality control program for compliance with Joint Commission and State and Federal requirements.

13. Review of Clinical Protocols for dose optimization.

14. Scout Prescription and Alignment Light Accuracy.

15. Spatial Resolution.

16. Artifact Evaluation.

17. CT Number Uniformity.

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

19. Gray Level Performance of CT Acquisition Display Monitors.

Services Section D

MEDICAL PHYSICS SERVICES FOR MRI UNITS

basis. The tests will be performed to help ensure compliance with applicable State, Federal, and Joint Commission and ACR regulations and guidelines. The physicist will visit the facility for whatever length of time is necessary for the performance of these tests.

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

1. Geometric Accuracy

2. High Contrast Spatial Resolution

3. Slice Thickness Accuracy

4. Slice Position Accuracy

5. Image Uniformity

6. % Signal Ghosting Ratio

7. Low Contrast

8. Inter-slice RF Interference

9. Coil Performance:

a. Volume coils signal-to-noise ratio

b. Volume coils image uniformity

c. Volume coils Ghosting Ratios

d. Surface coils signal-to-noise ratio

10. Image Artifact Evaluation

11. Magnet Visual Inspection

12. Magnetic Field Uniformity

13. Evaluation of site’s Technologist QC Program.

Services Section E

MEDICAL PHYSICS SERVICES FOR DENTAL

The services below will be provided by a qualified Medical Physicist on an annual basis.

The tests will be performed to help ensure compliance with applicable State, Federal, and Joint Commission and ACR regulations and guidelines. The inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities (most recent version).

The physicist will visit the facility for whatever length of time is necessary for the performance of these tests. 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)

Dental CBCT Acceptance and Performance Testing

Acceptance Testing. Acceptance testing and measurements of air kerma at the isocenter for each kVp station for a range of clinically used mAs settings shall be 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.

Performance Testing. Each CBCT unit shall undergo periodic quality control tests to ensure 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 13 months, and after repairs to the CBCT unit that may affect the radiation output or image quality.

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 may be performed in addition to the QA tests in this PWS.

Acceptance and Annual physics testing for Dental CBCT

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.

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.

Beam quality Measure the half value layer (HVL) for aluminum. The minimum shall comply with the Suggested State Regulations for Control of Radiation or recognized National standards.

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.

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.

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

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

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).

Review of the technical QA program The Contractor 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.