1. Quality Assurance: Manufacturer & Clinical Aspects  Alan Cohen, M.S. DABR  Paul Naine, MSc. MIPEM  Jim Schewe, PhD, DABMP Accuray Incorporated Elekta Incorporated Philips Radiation Oncology Systems

2. Quality Objectives Manufacturer  Design and manufacture a product to serve a clinical purpose  Ensure product is designed & built safely  Acceptance: Test product after installation to ensure proper function and safety Clinical User  Select products to deliver a desired clinical test/treatment  Commissioning: –Characterize product for use in clinic –Test product after installation to ensure function and safety in the clinical workflow  Ongoing QA 2

3. 3 Clinical Health Care Providers Clinical Health Care Providers Manufacturer Regulatory FDA Etc. Regulatory FDA Etc. Clinical Guidelines AAPM ASTRO RTOG Patient Interactions Standards ISO IEC Standards ISO IEC

4.  Manufacturer –Follow International Safety Standards –Design QA: Validation & Verification –Production QA & Testing –Installation & Acceptance –Product Training –Tools for Clinical QA  Clinical User (under direction of Medical Physicist) –Encompasses entire clinical workflow –Clinical QA of Equipment & Process:  Up Front: Commissioning  Recurring – daily, monthly, annual  Per “Event”: Patient, Plan, Fraction QA Roles and Responsibilities 4

5. Clinical QA Roles and Responsibilities Clinical Guidance: AAPM Task Group Reports Commissioning Machine QA Routine device QA Patient QA Patient-specific QA

6. Clinical QA Roles and Responsibilities Clinical Guidance: AAPM Task Group (TG) Reports  TG 40: Comprehensive QA for Radiation Oncology  TG 142:QA of Medical Accelerators  TG 53 QA for Radiation Treatment Planning  TG 51: Protocol for clinical reference dosimetry of high-energy photon & electron beams  TG 100: Method for Evaluating QA Needs in Radiation Therapy (in process)  And more: –Other TG Reports –ASTRO Safety White Papers –RTOG –… 6 https://www.aapm.org/pubs/reports/default.asp

7. Clinical QA Roles and Responsibilities Different Types of Clinical Users  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator 7

8. Primary responsibility for overall QA program –Definition –Tolerances –Frequency Acceptance and commissioning Output calibration Measured data (TDS  TPS) Knowledge of all equipment & software limitations Interoperability between devices Treatment plan review & approval Clinical QA Roles and Responsibilities Radiation Oncology Physicist  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator 8 Certification: American Board of Radiology American Board of Medical Physicists Canadian College of Physicists in Medicine State License (where applicable)

9. Clinical QA Roles and Responsibilities Radiation Oncologist  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator Dose prescription Tumor & normal tissue definition Define dosimetric constraints Final plan approval Monitor patient physiology 9 Certification: American Board of Radiology State License

10. Clinical QA Roles and Responsibilities Radiation Therapist  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator Delivery of prescribed radiation Daily positioning & immobilization –Consult physicist, MD as necessary Monitoring patient condition –Consult physician as necessary Detect potential problems: –Equipment –Patient changes –Human errors Understand safe operating limits May assist with some routine equipment QA 10 Registration: ASRT American Society of Radiation Therapists State License (where applicable)

11. Clinical QA Roles and Responsibilities Medical Dosimetrist (Treatment Planner)  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator Patient data acquisition Treatment plan design Manual/automated dose calculations May assist with equipment QA –Under supervision of physicist 11 Certification: Medical Dosimetrist Certifying Board

12. Clinical QA Roles and Responsibilities Administrator  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator Assign Resources for each role –Human –Budget –Equipment –Training (time & budget) Manage Department interactions and needs 12

13. Clinical QA Roles and Responsibilities All Clinical Staff  Physicist  Physician  Radiation Therapist  Dosimetrist  Administrator “The QA program has clinical, physical, and administrative components and its implementation requires the teamwork of all personnel.” (from AAPM TG 40: Comprehensive QA for RO) 13

14. Summary Quality Assurance is Essential to Safety & Quality  Device Quality Assurance by Manufacturers is: –Guided by regulatory and technical standards –Specific to a given device  Clinical Quality Assurance is: –Guided by clinical standards (AAPM, ASTRO, etc.) –Performed under direction of the Medical Physicist  Supported by other clinical users  Supported by manufacturers –Broad in scope, encompassing the entire system of patient care:  Devices  Human Interactions  In-house Clinical Workflow

15. Conclusions Tying it Together  Radiation Oncology Devices are designed for use by trained medical professionals –Training –Certification –Licensure  Clinical Standards of Care (e.g. AAPM TG reports) drive clinical practice, including QA  Device Design and Risk Management is guided by: –Roles & Responsibilities for Practice and QA by Professional Organizations –Clinical Standards of Care