Second (2) Revised SOW Medical Phsicist equipment list-2024-2025.docx

Statement of Work Medical Physicist Services Pine Ridge Service Unit

Section 1: General Information

1.1 General: This is a non-personal services contract to provide medical physics services for the Pine Ridge Comprehensive Health Care Facility (PRCHCF). This survey will also include the Kyle Health Center and the Wanblee Health Center. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2 Period of Performance:

Physical survey must be conducted during May of each year and reports are due within 30 days of completion. Assistance to create corrective action plan, review plan with program director, and re-evaluate to ensure compliance is acceptable may occur within the following 11 months. Total Period of performance is April 17, 2024 through April 16, 2025.

1.3 Place of Performance: Pine Ridge Comprehensive Healthcare Facility PO Box 1201 Pine Ridge, South Dakota 57770

1.4 Hours of Operation: All work shall be performed during business hours of 8:00 am to 5:00 PM. If a service has begun during regular business hours and it must be completed before any patients can be imaged according to the American College of Radiology (ACR), The Joint Commission (TJC), or the Mammography Quality Standards Act (MQSA), then the physicist must complete the service.

1.5 Location of Services:

· Pine Ridge Hospital 607 Indian Health Rd Pine Ridge, SD 57770

· Kyle Health Center 1000 Health Center Rd Kyle, SD 57752

· Wanblee Health Center 210 1st ST Wanblee, SD 57577 (These 3 locations are all more than 90 miles separation)

1.6 Type of Contract: The government will award a Firm Fixed Price One Year Contract

1.7 Invoicing: All invoices from the contractor shall be submitted electronically via the IPP (Invoice Payment Platform) to the Property & Supply Supervisor for Payment Processing.

· -Invoice Contact Information: 605 455-8223

· -Invoice Questions email: janelle.byrne@ihs.gov Contract Officer Representative II

Section 2: Definitions & Acronyms

2.1 Definitions:

Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government.

Work Day. The number of hours per day the Contractor provides services in accordance with the contract is an 8-hour day.

2.2 Acronyms:

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AAPM

ACR

CBCT

CFR

COR-NA

CT

FOV

HVL

IEC

MQSA

MRI

NCRP

PET

QA

RSO

SMPTE

SOW

SPECT

TJC

American Association of Physicist in Medicine American College of Radiology Cone Beam Computed Tomography Code of Federal Regulations Contracting Officer Representative-Non-Applicable Computed Tomography Field of View Half Value Layer International Electrotechnical Commission Mammography Quality Standards Act Magnetic Resonance Imaging National Council for Radiation Protection Positron Emission Tomography Quality Assurance Radiation Safety Officer Society of Motion Picture and Television Engineers Statement of Work Single-Photon Emission Computed Tomography The Joint Commission

Section 3: Government Furnished Property, Equipment, and Services

None

Section 4: Contractor Furnished Items and Services

The Contractor shall provide all equipment, supplies, management, supervision, personnel, and transportation necessary to assure that all services are in accordance with the contract and all applicable laws and regulations. The contractor shall ensure all work meets performance standards specified in this Statement of Work (SOW).

Section 5: Specific Tasks

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).

5.1 General Requirements

A. All Radiation Physicists performing services under this contract shall work under a Qualified Medical Physicist (QMP). A Qualified 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. The contractors must submit evidence of board certification with their quote and solicitation submittal.

5.2 Required Services

A. Dosimetry Badge Program: Radiation Dosimeter services to be provided for CLIENT Radiology Department by Vendor

1) Communicate with dosimeter provider and utilize website for tracking and data entry of CLIENT staff members

2) Maintain Account with under XX dosimeters

i. Quantities: maximum of 46 for Pine Ridge, 2 for Kyle Health Center and 1 for Wanblee Health Center (total maximum of 49 badges per year) to be billed as requested per quarter.

ii. Departments: - add and update accounts as needed (PRSU Hospital Radiology, Kyle Health Center Radiology, and Wanblee Health Center Radiology

iii. Participants: process paperwork and utilize provider website to add, change, and discontinue participants

iv. Badges: process paperwork and utilize website to add, change, and discontinue body and ring dosimeters. Exchange on a quarterly basis as industry standard

v. Fetal Badges: process paperwork for declaration of pregnancy and process paperwork and utilize website to coordinate monthly fetal monitoring

vi. Recalculations: communicate and process paperwork for:

a. Improper wear or handling of dosimeter

b. Lost or damaged dosimeter

c. Unworn dosimeter

d. Participants prior exposure for accurate cumulative lifetime exposure

3) Reporting

i. Send Form 5 annual report to all badged participants

ii. Review exposure reports for wear period

iii. Notify RSO of exposures exceeding ALARA limits

iv. Provide exposure history for terminated participants

v. Provide exposure history to other employers for past participants, when requested

vi. Request and collect prior exposure history for newly badged participants

NOTE: Pine Ridge will supply the names of new hires with estimated entry on duty dates so that badges can be on hand for implementation and separation dates with end dates so that badges may be canceled for the upcoming quarter.

B. Equipment Inspections A. All imaging equipment shall be inspected at least annually in May- June, not to exceed 14 months. Other inspections as defined below (new equipment, repairs, shielding (lead aprons), etc.) shall be completed as needed. A complete electronic report in “pdf” format shall be provided to Radiology Supervisor, Biomedical Engineering and the Radiation Safety Officer (RSO) or a printed (hard copy) version of the report results shall be provided within 30 days after completion of the inspection.

B. Missed or errors in performance for required elements will be corrected at the expense of the contractor. If errors are found in reports, corrections in “pdf” form will be submitted expeditiously.

C. The qualified diagnostic Medical Physicist shall perform imaging equipment (X-ray equipment, CT, and Dental units) inspections to ensure compliance with the current Regulatory agency requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Radiology Supervisor, Biomedical Engineering and the 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 must be reported to the RSO immediately upon discovery.

D. 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 and MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and 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 Biomedical Engineering and the RSO immediately upon discovery.

E. 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 where required. In cases where the unit may not be used clinically until inspected by a physicist, the inspection must be completed within 72 hours after the facility contacts the contractor. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and the 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 Biomedical Engineering and the RSO immediately upon discovery. Where acceptable, the physicist will review and accept the repairs report from Engineering.

F. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, such as safety training, reading dosimetry badge reports, i.e.

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

B. Radiation Safety Audit H. The qualified diagnostic medical physicist will review the program and perform a Radiation Safety Audit for the facilities. (3 facility locations), physical cite visit to each location is required for Pine Ridge Hospital, Kyle Health Center and Wanblee Health Center.

I. 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.

J. 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.

K. The qualified diagnostic medical physicist shall review the report from Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found. The contractor will perform a follow-up inspection if necessary according to ACR, MQSA, or other relevant standards.

5.3 Equipment Inspections Descriptions

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.

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. 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.

B. Digital Radiography (DR)

Physics inspections of 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 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 or latest revision. 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):

Review of Clinical Protocols.

1) Scout Prescription and Alignment Light Accuracy.

2) Image Thickness – Axial Mode.

3) Table Travel Accuracy.

4) Radiation Beam Width.

5) Low-Contrast Performance.

6) Spatial Resolution.

7) CT Number Accuracy.

8) Artifact Evaluation.

9) CT Number Uniformity.

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

11) 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 Cone Beam Computed Tomography (CBCT) Acceptance and Performance Testing

a) 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.

b) 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 14 months, and after repairs to the CBCT unit that may affect the radiation output or image quality.

c) 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 SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW.

Acceptance and Annual physics testing for Dental CBCT

a) 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.

b) 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.

c) kVp Accuracy

Measure the kVp at all clinically used settings. The measured kVp should be +/-5% of the selected kVp.

d) kVp Repeatability

Make five kVp measurements each for two clinically used kVp settings. All measured values should be +/-5% of the mean kVp.

e) kVp Reproducibility

Measure the kVp at all available kVp settings. The measured values should be +/-5% of the baseline.

f) 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.

g) 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.

h) Image Quality Image the phantom provided by the manufacturer or another suitable phantom. Assess high contrast spatial resolution, uniformity of trans axial images, and image noise.

Imaging uniformity shall be assessed over the entire range of axial images.

i) Accuracy of Linear Measurements

Using images of an appropriate phantom, assess the accuracy of distance measurements.

j) Accuracy of Patient Dose Metric Indication

Assess the accuracy of the indicated dose metric (typically DAP).

k) 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)

l) 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.

m) Display Monitors

Perform a visual analysis of the SMPTE test pattern.

i. 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.

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

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

2. Review the black-white transition.

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

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

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

v. Measure the brightness near the center of the monitor and near all 4 corners (or all 4 sides, depending on the test pattern used).

n) Viewing Conditions

Assess the viewing conditions for the area in which the monitor used to evaluation the CBCT studies is located.

5.4 Equipment List

PINE RIDGE X-RAY UNITS

PINE RIDGE DENTAL

KYLE X-RAY UNITS

WANBLEE X-RAY UNITS