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QA Violations. A Look at the First 3 Years. QA-Preparing the Facilities. Remembering the Beginnings- Subchapter 22 Quality Assurance Regs Workshops provided QA education Over 1500 registrants in attendance Compliance Guidance Documents. QA Findings Year 1.
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QA Violations A Look at the First 3 Years...
QA-Preparing the Facilities Remembering the Beginnings- Subchapter 22 Quality Assurance Regs Workshops provided QA education Over 1500 registrants in attendance Compliance Guidance Documents
QA Findings Year 1 Inspectors--inspection review to ensure QA program started. --Medical Physicist QC Survey completed --QA Manual completed --Initial QC tests completed --Processor QC started
QA Findings Year 2 AHA! . . .QA Program and QC testing . . . here to stay! Some registrants stored, disposed of units Inspectors checking QC reports thoroughly Annual Medical Physicist QC Survey - - - actually meant ANNUAL!
QA Findings Year 3 Continue to perform thorough reviews during inspection Registrants still not performing all QC tests at specified time intervals Repeat Violations result in monetary penalty assessments
TRENDS What types of violations are we seeing? How do they impact the work of the QA Medical Physicist?
QC VIOLATIONS What 5 violations do you think are the MOST POPULAR?
1st Most Popular QC Violation Missing QC Test Items - Rad 46% Year 1 2 3 Total # Violations 741 819 512 2072
2nd Most Popular QC Violation No annual Medical Phys. QC Survey - Rad 18% Year 1 2 3 Total # Violations 346 239 240 825
3rd Most Popular QC Violation No or Incomplete QA Manual 11% Year 1 2 3 Total # Violations 323 104 82 509
4th Most Popular QC Violation No QA Program 8% Year 1 2 3 Total # Violations 345 11 20 376
5th Most Popular QC Violation Processing Film when QC Test Failed 7% Year 1 2 3 Total # Violations 123 90 102 315
Medical Physicists’ Role How do these violations impact the work of the QA Medical Physicist?
QA Violations & Medical Physicists Medical Physicist’s Annual QC Survey MP review all the periodic QC tests - done and reported properly If test items are missing - must be noted on the annual QC Survey If items are missing, the facility FAILS in these items
QA Violations & Medical Physicists Medical Physicist’s Annual QA Program Review MP review with the Registrant: QA program & QA Manual Registrant must: document the periodic tests Table 1 throughout the year See the FAQs for more information
QA Violations & Medical Physicists Documentation is very important! When inspectors find QC test violations, sometimes the MP QC survey indicates the facility passed, some items not done. Confusion for registrant. The MP annual QA Review - facility missed some QC tests. NOTE: ALL test result records MUST BE made available for review by the certified medical physicist and the state inspector.
QA Goals • Increase Registrant Compliance • BRH Inspector & Physicist • communication • collaboration • Educate Registrants • how to lower ESE • how to improve IQ
Quality Assurance THANK YOU! GRACIAS! MERCI BEAUCOUP!