10/8/12. Radiation Reduction and Monitoring Program: What the FDA and Other Regulatory Agencies Want. Disclosures. Two Principles of Radiation Safety

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Beryl Gordon
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NASCI October 16, 2012 Radiation Reduction and Monitoring Program: What the FDA and Other Regulatory Agencies Want Tessa S.

dose monitoring tool (http://www.radiancedose.

and patient safety California Senate Bill 1237 Our dose monitoring/reduction efforts at Penn What the future may bring Justification Benefit from

1 NASCI October 16, 2012 Radiation Reduction and Monitoring Program: What the FDA and Other Regulatory Agencies Want Tessa S. Cook, MD PhD Hospital of the University of Pennsylvania Philadelphia, PA, USA Disclosures Principal developer of RADIANCE free, open- source CT dose monitoring tool ( Overview Two Principles of Radiation Safety FDA efforts in dose reduction and patient safety Joint Commission guidelines on dose reduction and patient safety California Senate Bill 1237 Our dose monitoring/reduction efforts at Penn What the future may bring Justification Benefit from the imaging procedure outweighs risk to the patient Dose optimization ALARA Exam should be tailored to clinical question, patient size, anatomy being imaged Proper equipment maintenance and testing Based on ICRP Publication 105 (2007), Radiological Protection in Medicine 1

Components of the FDA Initiative The FDA Initiative Under ICRP 105 Education

use Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

development Justification Education & communication Appropriate use Facility

radiation safety metrics Optimization Research & development Facility

regulations already in place for mammography Collaboration with CMS

Medicare patients Separate guidelines for hospitals State regulations Suggested

Radiation Control Program Directors Special guidelines for medical physicists

patients and medical professionals Collaborations ImageGently, ImageWisely,

2 Components of the FDA Initiative The FDA Initiative Under ICRP 105 Education and communication Facility guidelines and personnel qualifications Appropriate use Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging Equipment safety features Tracking radiation safety metrics Research and development Justification Education & communication Appropriate use Facility guidelines & personnel qualifications Equipment safety features Dose Tracking radiation safety metrics Optimization Research & development Facility Guidelines & Personnel Qualifications Education & Communication MQSA extensive regulations already in place for mammography Collaboration with CMS Accreditation required by ACR/IAC/JC of freestanding facilities that image Medicare patients Separate guidelines for hospitals State regulations Suggested State Regulations for Control of Radiation prepared by the Conference of Radiation Control Program Directors Special guidelines for medical physicists in CA since SB 1237 Goal: promote awareness of radiation safety issues among patients and medical professionals Collaborations ImageGently, ImageWisely, IAEA, NCRP, ICRP Specific guidelines for pediatric imaging Patient Medical Imaging Record Card EHR incentives under Meaningful Use 2

Education & Communication Education & Communication Collaboration with ImageWisely to improve online availability of dose reduction resources Specific information from the major CT vendors Member of

Radiation Safety in Cardiovascular Imaging Appropriate Use Collaborative effort to address over- utilization of medical imaging ACR Appropriateness Criteria ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR

justification in medical imaging Equipment Safety Features Tracking Radiation Safety Metrics Equipment guidelines Default protocols to optimize dose delivery Dose reduction features Automatic

3 Education & Communication Education & Communication Collaboration with ImageWisely to improve online availability of dose reduction resources Specific information from the major CT vendors Member of AAPM Working Group on Standardization of CT Nomenclatures and Protocols Collaboration between AAPM, ACR, ASRT, MITA Consensus for common CT protocols Consensus list of common terms across vendors Radiation Safety in Cardiovascular Imaging Appropriate Use Collaborative effort to address over- utilization of medical imaging ACR Appropriateness Criteria ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR Appropriate Use Criteria for Cardiac CT (2010) CMS Medical Imaging Demonstration ABR Foundation summit (2009) Collaborations with ICRP re. justification in medical imaging Equipment Safety Features Tracking Radiation Safety Metrics Equipment guidelines Default protocols to optimize dose delivery Dose reduction features Automatic notification before high dose delivery Controls to limit modification of protocols and settings Standardized dose reporting RDSR collaboration with DICOM, MITA IHE REM compliance Collaborations with MITA, AAPM, IEC Dose Check notifications and alerts Metrics: dose data, adverse events National registries and databases Equipment should automatically record dose, protocol data, patient information in standardized formats Collaborations with ACR, MITA, ImageGently, IAEA Collaboration with CRCPD to develop adverse events database 3

Research and Development Image quality metrics for assessment of dose reduction More accurate dose quantitation Better phantoms both physical and computerized Faster simulations for dose estimation

Reference doses based on anatomy, study type, patient size Correct protocols for clinical indication Protocol review process annual or biannual Investigate patterns outside expected range Track doses

4 Research and Development Image quality metrics for assessment of dose reduction More accurate dose quantitation Better phantoms both physical and computerized Faster simulations for dose estimation Organ dose estimation Assessment of the impact of iterative reconstruction JC: Reducing Risk Due to Avoidable Diagnostic Radiation Joint Commission: Right Test Right dose Effective processes Safe technology Better alternate modality? Appropriateness criteria; dialogue with referring MDs Right test Reducing Risk Safety culture Joint Commission: Right Dose Joint Commission: Effective Processes ALARA/ImageGently/ImageWisely Reference doses based on anatomy, study type, patient size Correct protocols for clinical indication Protocol review process annual or biannual Investigate patterns outside expected range Track doses for exams repeated due to insufficient image quality Record dosage/exposure in the study report Policies for password protection of protocols and their modification Oversight by a group with expertise in radiation, e.g. radiation safety committee Physical protective risk reduction measures, e.g., lead shielding for patients and techs; radiation protection training for techs Expand RSO s role to include patient radiation safety Dose training and specific equipment training for all physicians and techs; annual review & competency testing 4

Joint Commission: Safe Technology Joint Commission: Additional Points Organization- wide audit of all diagnostic imaging equipment with the potential to generate high radiation doses Implementation

standards Perform required QC and preventative maintenance Endorsement of national registry for tracking radiation doses to identify optimal and reference doses Encouragement of manufacturers to

5 Joint Commission: Safe Technology Joint Commission: Additional Points Organization- wide audit of all diagnostic imaging equipment with the potential to generate high radiation doses Implementation of monitoring of these systems, led by medical physicist, radiation safety committee or both Testing of equipment every 2 years, led by medical physicist, according to state & federal laws, AAPM standards Perform required QC and preventative maintenance Endorsement of national registry for tracking radiation doses to identify optimal and reference doses Encouragement of manufacturers to include safeguards against high doses and capture information to the medical record and transmit it to the national registry Support of stricter regulations to eliminate avoidable imaging and monitor the appropriateness of self- referral Invest in dose reduction or dose optimization technologies Joint Commission: Actions to Eliminate Avoidable Radiation Dosing Comprehensive patient safety program, including education re. dose in imaging departments Awareness of potential dangers from diagnostic radiation Adequate awareness of levels of radiation used and related risks Training on complex new technology Guidance in use of potentially dangerous procedures/equipment Knowledge of typical doses Clear protocols that identify the maximum dose for each study type Consulting a qualified medical physicist when modifying/designing protocols Communication among clinicians, medical physicist, techs, staff Safety, operational, functional equipment checks periodically Adequately trained & competent staff California Senate Bill SB 1237 Our Efforts at Penn General requirements Record dose in report or attach dose sheet Send dose sheet to PACS Verify that doses are within 20% of display (annual) Dose reporting CTDI vol DLP SSDE (AAPM) Facility accreditation All CT facilities by 7/1/13 Accreditation body approved by CMS, CA Medical Board, DPH Medical event reporting Repeated exam or incorrect body part resulting in 0.05 Sv effective dose 0.5 Sv to organ/ tissue or skin Unanticipated hair loss, functional damage, erythema >50 msv to embryo/ fetus, unapproved Radiation dose monitoring Protocol review and optimization for dose reduction Hands- on protocoling of cardiovascular exams Increased education of residents, fellows, technologists regarding dose, protocols Newer technologies (high- pitch imaging, iterative reconstruction) for dose reduction 5

6 What the Future May Bring Other states legislation on the horizon? CMS? Dose and reimbursement? Questions? 6

Radiation Dose Management Requirements from MACRA and Joint Commission, Potential Effects on Reimbursement

Radiation Dose Management Requirements from MACRA and Joint Commission, Potential Effects on Reimbursement Radiation dose requirements are being slowly integrated into key performance indicators and metrics