A05 - SOW Medical Physicist2.pdf

STATEMENT OF WORK (SOW)

PURPOSE OF THE CONTRACT

The primary purpose of this contract is to hire a contractor to assist the department in conducting Radiological Physics Surveys on x-ray equipment.

STATEMENT OF WORK

The Contractor shall be responsible for providing all necessary labor, equipment, and supplies to conduct Radiological Physics Surveys on the x-ray equipment located at the Fort Belknap Hospital, Harlem, MT and Eagle Child Health Clinic, Hays, MT.

Radiology units will be surveyed annually, as well as after a new unit is installed, or when a new tube is placed. Dental Operatory units, and Dental Panorex units will be surveyed every four (4) years, and are due in Option Year one (1) of this contract.

Reports will be required for each unit surveyed.

Equipment includes, but is not limited to: medical above table unit, portable unit, mammography unit, dental operatory units, and dental panorex units:

Fort Belknap: 1 - Radiographic Fixed Room 1 - Radiographic Portable 1 - Mammographic 3D Unit 5 – Dental Units + 1 Panorex—Option Year one only

Hays: 3 – Dental Units + 1 Panorex----Option Year one only

MAJOR DUTIES:

The Contractor shall conduct the following QC tests on the Mammography equipment:

• Mammographic Unit Assembly Evaluation

• Collimation Assessment

• Artifact Evaluation

• kVp Accuracy and Reproducibility

• Beam Quality Assessment – HVL Measurement

• Evaluation of System Resolution

• Automatic Exposure Control (AEC) Function Performance

• Breast Entrance Exposure, AEC Reproducibility and Average Glandular

Dose

• Radiation Output Rate

• Phantom Image Quality Evaluation

• Signal-To-Noise Radio and Contrast-To-Noise Ratio Measurement

• Diagnostic Review Workstation (RWS) QC

• Detector Flat Field Calibration

• Compression Thickness Indicator

• Compression

The Contractor shall evaluate the site’s Technologist QC Program to include:

• Artifact Evaluation

• Signal-To-Noise and Contrast-To-Noise Measurements

• Phantom Image

• Detector Flat-Field Calibration

• Compression Thickness Indicator

• Visual Checklist

• Reject Analysis

• Compression

• Review Workstation QC - Overall

The Contractor shall conduct the following tests on the Radiographic Equipment:

• kVp Accuracy

• Beam Quality (Half-Value Layer)

• Exposure Reproducibility

• Timer Accuracy

• mAs Calibration

• Entrance Skin Exposures

• Scatter Radiation Measurements

• Light and Radiation Field Congruence

• Indication of Exposure exists

• Technique Factors

• X-ray Field

• Exposure Switch

• Radiation protective apparel is provided

• Radiation Monitoring Badges are provided

DELIVERABLES COVERED BY CONTRACT:

1. Review, recommend improvements, provide examples if needed, and evaluate compliance with each radiology program’s policies, procedures, and protocols to ensure the program has policies in place consistent with their scope of work that are sufficient to protect staff and patients and minimize patient dose and are reviewed annually. Policies on the following minimum topics should be in place and implemented.

*Staff qualifications *Equipment maintenance process and documentation *Personnel monitoring and means to prevent/reduce exposure using ALARA principal *Patient dose estimation, documentation, and reporting *Protection of pregnant patients and workers; fetal protection and dose calculation *Equipment Performance Monitoring *Protective equipment inspection *Quality Assurance/ Performance improvement *Annual imaging program evaluation *Management of imaging records *Radiation Safety Officer appointment and scope of responsibilities *Patient incident and over-exposure reporting and analysis.

2. Contactor shall provide consultation to assure an optimized balance between image quality and patient dose by ensuring the optimum technique factors are utilized by the facility

3. Contractor shall evaluate patient dose/Entrance Skin Exposure with comparison to FDA NEXT or equivalent diagnostic reference levels via patient dose estimates using appropriate phantoms.

REQUIREMENTS:

A. Contractor shall conduct “Device Performance” and “Quality Control Measures” activities listed in table 2 and according to AAPM Report 74 (http://www.aapm.org/pubs/reports/rpt_74.PDF) and consistent with the below cited references, and will assist in establishing a facility radiology quality assurance program. Table 3 lists the equipment by location.

B. The contractor will provide details to the local site contact on any equipment that is not in proper working condition, or any environmental condition negatively impacting patient safety/privacy or program operations. The local site contact will follow up on necessary service calls or maintenance under a separate purchase order through proper acquisition channels. It is not expected that the contractor bidding will provide any maintenance services, just recommendations for repair or servicing.

C. The contractor will provide acceptance testing for new x-ray devices installed during the contract period when directed by a properly executed supplement agreement/change order.

D. The contractor shall include additional equipment and Radiation Shielding Surveys under this contract when directed by a properly executed supplement agreement/change order.

E. The contractor shall consult with the Lead X-Ray Technician concerning patient and fetal dose determinations under this contract when needed. (To be procured through a separate purchase order).

References:

• ACR–SPR Practice Parameter for General Radiography Res. 30 – 2013, Amended https://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/General_Radiograph y.pdf

• American College of Radiology Appropriateness’ Criteria and Diagnostic Radiology Guidelines https://acsearch.acr.org/list)

• Protecting Access to Medicare Act, 2014

• CY 2017 Physician Fee Schedule (PFS) Final Rule https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdf

• Scope of Practice of Clinical Medical Physics https://www.aapm.org/org/policies/details.asp?id=317&type=PP

• Quality Control in Diagnostic Radiology AAPM Report 74

(http://www.aapm.org/pubs/reports/rpt_74.PDF

• FDA, Mammography Quality Standards Act Regulations (MQSA). 21 CFR §900.

http://www.fda.gov/Radiation- EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm1 10906.htm

• NCRP, Report Number 145 - Radiation Protection in Dentistry, October 2004.

http://www.aapm.org/pubs/reports/rpt_74.PDF https://www.acr.org/%7E/media/ACR/Documents/PGTS/guidelines/General_Radiography.pdf https://www.acr.org/%7E/media/ACR/Documents/PGTS/guidelines/General_Radiography.pdf https://www.acr.org/%7E/media/ACR/Documents/PGTS/guidelines/General_Radiography.pdf https://acsearch.acr.org/list https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdf https://www.aapm.org/org/policies/details.asp?id=317&type=PP http://www.aapm.org/pubs/reports/rpt_74.PDF http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm110906.htm http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm110906.htm http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm110906.htm

• ADA/FDA, The Selection of Patients for Dental Radiographic Examinations, November 28, 2012. http://www.fda.gov/Radiation-EmittingProducts/default.htm

• ACR–AAPM–SIIM Technical Standard for Electronic Practice of Medical Imaging,

• ACR Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Computed Tomography Equipment. 2007

• ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Radiographic Equipment, 2016.

• ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Fluoroscopic Equipment, 2016.

SCHEDULE:

Fort Belknap Hospital:

ITEM EQUIPMENT SURVEY

REPORT WRITING

Mammography 1 (one) visit Annually 1 (one) visit Annually Above Table X-Ray 1 (one) visit Annually 1 (one) visit Annually Dental Unit Option Year 1 only 1 (one) visit Annually

Eagle Child Health Clinic:

ITEM EQUIPMENT SURVEY

REPORT WRITING

Dental Unit Option Year 1 only 1 (one) visit Annually

A. Contractor shall schedule visits with the site’s Radiology Department for medical equipment surveys, and dental equipment surveys at least two weeks in advance of the proposed site visit.

B. Upon arrival at and before departing from the facility, the contractor’s representative shall physically check in with the Radiology Department.

C. All work shall be performed during the Normal Work Hours of Monday through Friday, except for Federal Holidays, 8:00A.M. through 4:30 P.M. Hours can differ if the facility is open for business 24/7 or if mutually agreed between the facility and contractor representative for the benefit of the surveyor.

http://www.fda.gov/Radiation-EmittingProducts/default.htm

MEDICAL PHYSICIST REQUIREMENTS

A. Medical Physicist Certification Requirements: The Services shall be performed by a certified qualified medical physicist meeting the American Association of Physicists in Medicine (AAPM) definition. AAPM defines a qualified medical physicist as, “an individual with the following credentials:

1. Has earned a master's or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education.”

(AAPM, 2012)

a. These certification requirements are consistent with the national practice guidelines referenced in Table 1. Medical physicist performance monitoring reports shall include verification of professional certification. For the subfield of Diagnostic Medical Physics, AAPM recommends certification by the American Board of Radiology; or the American Board of Medical Physics; or the Canadian College of Physicists in Medicine. (AAPM, 2012).

or

b. Radiation Physicists performing these services 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.

B. Radiation Safety Surveys - Performance Monitoring and Testing of Medical and

Dental Imaging Equipment: Services to meet the most recent nationally-recognized standards of practice regarding x-ray equipment performance monitoring and testing according to the American College of Radiology (ACR) and the National Council on Radiation Protection and Measurement (NCRP) Technical Standards. Contractor shall provide all supplies, kits, test equipment, tools and parts required to perform monitoring and testing services. All required services as noted below will be conducted.

2. Radiation Safety Surveys will be conducted according to ACR and NCRP standards and equipment manufacturers’ recommendations.

3. Performance Monitoring Tests and Services will be conducted according to the schedule noted in the table below, verify that new equipment meets manufacturer specifications and regulatory requirements, as well as identify any corrective maintenance or modifications to process or procedures that need to be addressed.

4. Contractor shall schedule visits with each site’s Radiology Department and Dental

Department at least two weeks in advance of the proposed site visit.

5. With thorough testing and measurements, contractor shall verify that any new radiology equipment meets manufacturer specifications and regulatory requirements, as well as identify any problem areas that need to be addressed.

PERFORMANCE MONITORING AND TEST TABLES

Table 1 – Medical Physicist Performance Monitoring Services

Modality Reference Physicist Services Radiology -above table, portable x-ray

ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Radiographic Equipment, 2016.

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring.

-Performance check after replacement or repair of major components. (To be procured through a separate purchase order).

-Annual assessment of patient dose.

-Review and, when necessary, recommend improvements to radiology program’s policies, procedures, and protocols to minimize patient dose.

-Establish and monitor performance of a facility quality assurance program.

Mammography -Mammography Quality Standards Act (MQSA) Regulations – 21 CFR Part 900 – Mammography

(FDA, 2009)

-Food and Drug Administration (FDA) Guidance for Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under

MQSA

(FDA, 2005)

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring which includes a summary of the evaluation of the facility quality control testing with any recommendations for necessary improvements and/or corrective actions, as needed.

-Performance check after replacement or repair of major components (including image processors). (To be procured through a separate purchase order).

Dental (includes panoramic devices)

NCRP Report Number 145:

Radiation Protection in Dentistry

(NCRP, 2003)

-All new dental x-ray installations and existing installations not previously surveyed shall have a radiation protection survey.

-Resurveys shall be performed; resurvey interval should not exceed 4 years.

-A resurvey shall be made after any change in the installation, workload, or operating conditions that might significantly increase occupational or public exposure (including x-ray machine service or repair that could affect the x-ray machine output or performance). (To be procured through a separate purchase order).

Table 2 – Standard Physicist Performance Monitoring Tests

Standard Physicist Performance Monitoring

Medical Dental Mammography

Optimizing Patient Dose Policies are in place and followed regarding protection of pregnant patients, credentialing and competencies verification of operators, who can prescribe, apron testing and frequency, etc.

X X X

Appropriateness of technique factors

X X

Patient Dose/Entrance Skin Exposure Evaluation with comparison to FDA NEXT or equivalent reference value via CDRH phantoms – Provide recommendations for reducing exposure if beyond expected 3rd quartile.

Adult Chest, Abdomen, &

Spine

Intraoral Adult

Bitewing

MQSA required medical physicist tests for certification.

21 CFR

900.12(e)(9) -

Surveys

Patient dose monitoring system calibration

X X X

Review or establishing technique charts

X X X

Recommended fastest screen-film system available, as needed

X

Staff Exposures

Policies are in place and followed regarding protection of staff, including pregnant staff, personnel monitoring, etc.

X X X

Appropriately donning radiation dosimeters, providing summary reports to staff, and maintaining exposure records

X X X

Standard Physicist Performance Monitoring

Medical Dental Mammography

Device Performance

Integrity of unit assembly.

X X MQSA required medical physicist tests for certification.

21 CFR

900.12(e)(9) -

Surveys

Automatic exposure control system performance

X kVp accuracy and reproducibility

X X

Linearity of exposure versus mA or mAs

X X

Exposure reproducibility

X X

Timer accuracy X X Beam quality assessment (half-value layer)

X X

Equipment radiation safety functions.

X X

Digital image receptor performance

If Digital If Digital MQSA required medical physicist tests for certification.

21 CFR

900.12(e)(9) -

Surveys

Tube Head Stability X Collimation Acceptance

Test (AT)

AT

Center and Bucky Alignment

AT

Source to Imaging Receptor Distance

AT AT

Other performance tests recommended by the manufacturer or physicist

AT AT MQSA required medical physicist tests for certification.

21 CFR

900.12(e)(10) – Mammography

Equipment Evaluations

Verification of preventive maintenance of devices.

Quality Control Review Repeat analysis X X X Artifact Review X X X Diagnostic Workstation

- Image monitors and viewing conditions

X X X

Darkroom and screen cleanliness, darkroom fog, analysis of fixer retention, screen-film contact analysis

If Film/Screen Processing

Processor quality control (time, temperature, chemical, reference film for daily comparisons and manufacturer recommendations as needed.

If Film/Screen

Computed Radiography and Digital Radiography (CR&DR) system performance – Uniformity. noise, contrast/sharpness, erasure

If CR&DR If CR&DR If CR&DR

Laser film printer quality control

As needed.

Exposure Indicator Analysis

If CR&DR If CR&DR If CR&DR

Integrity Test of Protective Clothing and other devices

X X X

Quality assurance log with record of observable quality variance and corrective action taken.

Completion of Service and Documentation: On completion of all performance monitoring and testing services, the contractor’s representative shall brief the locations Lead X-Ray Technician for medical x-rays and Dental Chief for dental x-ray tubes and provide documentation of all services that were performed; in addition, a copy of the report is to be provided to the Chief Medical Officer and the Division of Environmental Health Services (DEHS) Director of the Billings Area Office. The documentation shall be a prepared form that provides at a minimum the following information:

A. Documents the services performed for each item or system.

B. Shall be in an easily readable format.

C. Shall be of ink or print type that can be photocopied on a standard copy machine.

D. Documentation shall include:

1. Facility Location

2. Names of key staff contacted, interviewed, and/or briefed while on site

3. Equipment Model Number

4. Equipment Manufacturer’s Serial Number

5. Location of Equipment

6. Date of Service

7. Type of service performed

8. Identification of methods and instrumentation and supplies used

9. Results of any tests or inspections performed

a. Automatic Exposure Level Standards based on latest Conference of Radiation Control Program Directors (CRCPD).

10. Provide for a check off or sign off to indicate “unit fully operational as specified by original manufacturer”.

11. If deficiencies in equipment or operation are found, corrective action plan is provided to Radiation Program Manager at each Service Unit and to the Director, DEHS.

12. Method of identifying Contractor’s service personnel

13. Block for local IHS Personnel to sign and date when service is complete.

SERVICE LOCATIONS AND POINTS OF CONTACT:

Ft. Belknap Indian Health Center Bette Jo Snider, Radiology Dept 669 Agency Main St.

Harlem, MT 59526

(406) 353-3142

Eagle Child Health Center Bette Jo Snider, Radiology Dept 453 Pinegrove Rd.

Hays, MT 59527

(406) 353-3142

PERIOD OF PERFORMANCE

Performance of this purchase order shall be for 12 months from July 1, 2025, through June 30, 2026, with four (4) 12-month options. If the Government exercises the options pursuant to Federal Acquisition Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract (MAR 2000), the period of performance shall be extended in accordance with the following schedule:

Year Option Period

Option Year One (1) July 1, 2026 through June 30, 2027 Option Year Two (2) July 1, 2027 through June 30, 2028 Option Year Three (3) July 1, 2028 through June 30, 2029 Option Year Four (4) July 1, 2029 through June 30, 2030