1. FDA Public Meeting: Device Improvements to Reduce the Number of Under-doses and Misaligned Exposures from Therapeutic Radiation

2. Radiation Oncology Quality Assurance Program: Continuing Quality Improvement Eleanor Harris, MD Associate professor & Clinical director Department of Radiation Oncology H. Lee Moffitt Cancer Center and Research Institute Co-chair, ASTRO Emerging Technology Committee June 10, 2010

3. Establishing Quality Assurance Standards Challenges: –Standardization What needs QA? –Time and Effort Establishing efficient & automated processes Covering the costs –Adaptability Flexibility to adjust QA processes to new techniques & technologies

4. Error Prevention Tool: Failure Modes Effects Analysis The FMEA process was originally developed by the US military in 1949 to classify failures "according to their impact on mission success and personnel/equipment safety". Moffitt attempted FMEA for critical steps in stereotactic radiosurgery for brain tumors Risk Probability Number = S * O * D S – severity O – occurrence D – detection

5. Radiation Therapy Specific Severity Ranking of Errors 10.Potential to effect complete course of treatment (multiple fractions) of multiple patients by more than 10% 9.Potential to effect complete course of treatment of multiple patients by effecting the dose by greater than 3% but less than 10% Potential to cause a major change in the dose distribution or field borders for the complete course of treatment of multiple patients Potential to cause treatment of the wrong site or wrong patient for a complete course of treatment (single patient) 8.Potential to effect the dose throughout a complete course of treatment on a single patient by more than 10% 7.Potential to cause treatment of the wrong patient or site for a single fraction Potential to cause a major change in the dose distribution (e.g. wrong energy, wedge orientation) or field borders (e.g wrong f.s. or coll rot) for the complete course of treatment of a single patient 6.Potential to effect complete course of treatment of multiple patients by effecting the dose by less than 3%

6. Radiation Therapy Specific Severity Ranking of Errors 5.Potential to effect the entire course of treatment to a single patient, but effect on dose is less than 10%, or minor effect on the dose distribution (e.g. bolus vs no bolus) Treatment of a plan that does not match the prescription 4.Potential to have a major effect on the dose (>10%), dose distribution, or field borders for a single treatment 3. Potential to have minor effect on the dose (2-10%), dose distribution or field borders for a single treatment 2. Failure to treat a particular site on a given day Completion of treatment course without any port films 1.Minor errors due to change in patient status (e.g. SSDs don’t match plan for 3 tx or more) Potential to have effect on dose <2% for a single fraction (e.g. forgot to add bolus)

7. Radiation Therapy Specific Ranking: “Likelihood that an Error Could Go Undetected” 10.Once the act occurs there is no way to confirm whether an error occurred unless it is detected at the time of the act 9.Once the act occurs, the parameter in question is not typically checked or re-measured for a year or more. 8. A double-check is required, but is performed by the same person that committed the initial act using the same methodology 7.Once the act occurs, the parameter in question is not checked or re-measured for a time period ranging between one month and one year. 6. Once the act occurs, the parameter in question is not checked or re-measured for a time period ranging between one week and one month

8. Radiation Therapy Specific Ranking: “Likelihood that an Error Could Go Undetected” 5. Once the act occurs, the parameter in question is not checked or re-measured for a time period ranging between one day and one week 4. Once the act occurs, the parameter in question is checked within 24 hours of the act 3. The act is reviewed/discussed by a group prior to treatment delivery 2. The act is verified independently of the original act 1. Electronic verification of parameters before act is performed

9. How Would It Work? 1.Analyze a process identifying any possible failures and grading each one 2.Attempt to re-design process to reduce the highest scores. SODRPN MD does not draw correct target 819 72 All potentially curative patients are reviewed at peer review including a review of the drawn targets SODRPN MD does not draw target properly812 16 SODRPN Wrong wedge treated2210 40 All accelerators to be record and verify SODRPN Wrong wedge treated211 2

11. Highest risk: *Single fraction or small fraction # procedures. *New technologies. *Deviation from normal procedure.

13. QA Program Components Quality Control Boarding Pass - Dosimetry/MD verification of site, contours. Use of source documents No review = no plan MD/Dosimetry verification of instructions. MD plan review - MD verification that plan meets treatment objectives Initial Plan Check – Physics/Dosimetry verification of dosimetric plan. Independent calculation or measurement MD Peer Review – Peer physicians assess appropriateness of radiation therapy, radiation dose, contours/volumes and objectives. Pre-Port – MD verification of setup and consistency with plan Time Out- Therapist verification of setup

14. Emerging Technologies Often rapidly adopted in clinical practice with minimal assessment of clinical utility or comparative effectiveness: –Device safety studies do not address efficacy –Ease of conducting device approvals compared to clinical trials of efficacy –Lack of correlation of device safety approvals and coding/billing – Encourages multiple competing devices of unknown clinical benefit –Financial incentives outweigh clinical outcomes –“Horse out of the barn” effect

15. Emerging Technologies “Grey Zone” Technologies: –Not clearly regulated by FDA, NRC, etc. –State by state regulation –Companies market devices to non- Radiation Oncologists –Risk of inappropriate use by unqualified practitioners Risk of patient harm due to lack of expertise with radiation delivery or even cancer therapy

16. Future Directions Increasingly complex technology & treatment techniques require new QA approaches –Phantom QA of IMRT –Exit dosimetry Device functionality needs independent verification –At installation & periodically Development of standards & regulations for the most severe errors Accreditation standards may be required –ACR accreditation

17. FDA Role Work with ASTRO, AAPM, etc., to define quality of errors, develop QA standards and accreditation requirements Support organizations performing independent QA oversight Align device assessments with clinical efficacy and reimbursement levels

18. Thank you!