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American Board of Medical Specialties American Medical Association (AMA)-convened Physician Consortium for Performance Improvement® American College of Radiology Optimizing Patient Exposure to Ionizing Radiation Performance Measurement Set PCPI and ABMS approved April 2013 Updated January 2016 © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. CPT® Copyright 2004-2013 American Medical Association. T a b l e of C o n t e n t s Executive Summary Optimizing Patient Exposure to Ionizing Radiation (OPEIR) Measurement Set Purpose of Measurement Set Importance of Topic Opportunity for Improvement Clinical Evidence Base Optimizing Patient Exposure to Ionizing Radiation Outcomes Intended Audience, Care Setting, and Patient Population Optimizing Patient Exposure to Ionizing Radiation Work Group Recommendations Other Potential Measures Quality Improvement Measures/Additional Measures Included (Measures Not Developed by ABMS/ABR/ACR/PCPI Under This Project) Measure Harmonization Technical Specifications: Overview Measure Exclusions and Measure Exceptions Testing and Implementation of the Measurement Set Optimizing Patient Exposure to Ionizing Radiation Measures Measure #1: Reporting to a Radiation Dose Index Registry Measure #2: Utilization of a Standardized Nomenclature for CT Imaging Description Measure #3: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines Measures #4-6: Measures deleted Measure #7: Equipment Evaluation for Pediatric CT Imaging Protocols Measure #8: Utilization of Pediatric CT Imaging Protocols Measure #9: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies Measure #10: Search for Prior CT Studies through a Secure, Authorized, Mediafree, Shared Archive Measure #11: CT Images Available for Patient Follow-Up and Comparison Purposes Quality Improvement Measures/Additional Measures Referenced (Measures Not Developed by ABMS/ABR/ACR/PCPI Under This Project) Measure #12 (PCPI/ACR/NCQA): Exposure Time Reported for Procedures Using Fluoroscopy Measure #13 (Partners HealthCare/Brigham & Women’s Hospital): Pulmonary CT Imaging for Patients at Low-risk for Pulmonary Embolism Measure #14 (Partners HealthCare/Brigham & Women’s Hospital): Appropriate Head CT Imaging in Adults with Mild Traumatic Brain Injury Evidence Classification/Rating Schemes Summary of Non-Material Interest Disclosures References 5 9 9 10 10 11 11 11 14 14 14 15 15 16 17 20 23 27 30 33 35 38 41 42 43 43 44 47 48 © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. CPT® Copyright 2004-2013 American Medical Association. 2 The Measures are not clinical guidelines, do not establish a standard of medical care, and have not been tested for all potential applications. The Measures, while copyrighted, can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined as the sale, license, or distribution of the Measures for commercial gain, or incorporation of the Measures into a product or service that is sold, licensed or distributed for commercial gain. Commercial uses of the Measures require a license agreement between the user and the American Medical Association (AMA), [on behalf of the Physician Consortium for Performance Improvement® (PCPI®)], American Board of Medical Specialties (ABMS) and the American College of Radiology (ACR). Neither the AMA, ABMS, ACR, PCPI, nor its members shall be responsible for any use of the Measures. The AMA’s, PCPI’s and ABMS’s significant past efforts and contributions to the development and updating of the Measures is acknowledged. ACR is solely responsible for the review and enhancement (“Maintenance”) of the Measures as of August 1, 2014. ACR encourages use of the Measures by other health care professionals, where appropriate. THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use. Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, ABMS, ACR, the PCPI and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the specifications. CPT® contained in the Measures specifications is copyright 2004-2014 American Medical Association. LOINC® copyright 2004-2013 Regenstrief Institute, Inc. SNOMED CLINICAL TERMS (SNOMED CT®) copyright 2004-2013 College of American Pathologists. All Rights Reserved. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 3 Optimizing Patient Exposure to Ionizing Radiation Work Group Members W or k G r o u p M e m b e r s Milton J. Guiberteau, MD (Co-Chair) (nuclear radiology/diagnostic radiology) David Seidenwurm, MD (Co-Chair) (neuroradiology/pediatric and diagnostic radiology) Dennis M. Balfe, MD (diagnostic radiology) Dorothy Bulas, MD (pediatric radiology) Philip N. Cascade, MD (cardiothoracic radiology) C. Daniel Johnson, MD, MS, MMM (gi radiology) Richard L. Morin, PhD (radiologic physics) Robert D. Rosenberg, MD (diagnostic radiology) Howard Sandler, MD, MS (Physics) (radiation oncology) Rebecca Smith-Bindman, MD (diagnostic radiology) Christopher Wyatt, MHM (payer representative) Advisory Group Members Paul R. Sierzenski, MD, RDMS (emergency medicine) Liana Watson, DM, RT(R)(M)(S)(BS), RDMS, RVT (radiography/sonography) Sjirk J. Westra, MD (pediatric radiology) Scott Jerome, DO (cardiology/internal medicine) Paul M. Knechtges, MD (diagnostic radiology) John R. Maese, MD (internal medicine/geriatrics) Jason Sheehan, MD, PhD (neurosurgery) W or k G r o u p S t a f f American Board of Medical Specialties Richard Hawkins, MD Sheila Lazier Katie Small Robin Wagner, RN, MHSA Kevin Weiss, MD, MPH American Board of Radiology Gary Becker, MD Jennifer Bosma, PhD Paul Wallner, DO American College of Radiology Judy Burleson, MHSA American Medical Association Mark Antman, DDS, MBA Elvia Chavarria, MPH Anu Gupta, JD Kendra Hanley, MS Samantha Tierney, MPH PCPI Consultant Rebecca Kresowik © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. CPT® Copyright 2004-2013 American Medical Association. 4 Executive Summary Toward Improving Quality of Care for Patients Undergoing Imaging Studies Using Ionizing Radiation The American Board of Medical Specialties (ABMS) and the American Medical Association (AMA)convened Physician Consortium for Performance Improvement® (PCPI®) in collaboration with the American Board of Radiology (ABR) and the American College of Radiology (ACR) formed an Optimizing Patient Exposure to Ionizing Radiation (OPEIR) Work Group to develop a measurement set for implementation into Maintenance of Certification® (MOC) programs and toward improving the quality of care for patients undergoing high dose radiation studies, specifically computed tomography (CT) and myocardial perfusion imaging. Reasons for Prioritizing Optimal Patient Exposure to Ionizing Radiation High Impact Topic Area This topic was chosen for measure development because imaging studies are a significant source of radiation exposure and because of the high costs associated with these procedures. • • • • • The average per capita exposure to ionizing radiation from imaging exams increased by about 600% from 1980 to 2006 in the United States. 1,2 The largest contributor to this dramatic increase in population radiation exposure is the computed tomography (CT). In 1980 fewer than 3 million CT scans were performed; In 2006, there were about 380 million radiologic procedures (including 67 million CT scans) and 18 million nuclear medicine procedures performed in the United States.1,2 The imaging study with the single highest radiation burden, accounting for 22% of cumulative effective dose, is myocardial perfusion imaging. 3 Despite a comparatively small decrease in 2010, the cumulative growth in the volume of imaging from 2000 to 2009 totaled 85 percent. 4 From 2000 through 2006, total Medicare expenditures for physician imaging services increased from $6.7 billion to about $14 billion, an increase of approximately 13 percent per year on average. 5 Clinical Evidence Base Evidence-based clinical practice guidelines are available to optimize the radiation exposure for patient’s undergoing imaging. This measurement set is based on guidelines from: 1. American College of Radiology 2. National Cancer Institute 3. National Council on Radiation Protection and Measurements Optimal Patient Exposure to Ionizing Radiation Outcomes Ideally, a set of performance measures would include measures of outcomes as well as key process and structural measures known to positively influence desirable improvements and outcomes. The development of outcome measures for optimizing patient exposure to ionizing radiation proved particularly challenging because of the cumulative and potentially latent effects of radiation. In light of these difficulties, the Work Group set out to develop performance measures based on structures and processes that will reflect high quality care and a step toward achieving desired outcomes. Desired outcomes for optimizing patient exposure to ionizing radiation include to: 1. Reduce the potential for patient harm 2. Reduce excessive radiation risks and exposures 3. Reduce procedural complications 4. Reduce morbidity in patients who undergo medical imaging 5. Reduce inappropriate and/or unnecessary repeat imaging 6. Encourage recording of medical imaging exam radiation dose indices and reporting of patientlevel tracking of imaging exams conducted 7. Enhance awareness of risks associated with medical imaging 8. Encourage appropriate utilization of ionizing and nonionizing radiation © 2013 American Medical Association and American Board of Medical Specialties. All Rights Reserved 5 Optimizing Patient Exposure to Ionizing Radiation Work Group Recommendations Process measures: Key processes of care designed to improve the quality of care for patients undergoing ionizing radiation imaging are recommended: Measures addressing safety, efficiency and appropriateness Measure #3: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines Measure #9: Count of Potential High Radiation Dose Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies Structural measures: Several structural measures, designed to reduce unnecessary or repeat imaging and radiation exposure through the use of protocols and health information technology are recommended: Measures addressing the recording and reporting of imaging procedures Measure #1: Reporting to a Radiation Dose Index Registry Measure #2: Utilization of a Standardized Nomenclature for CT Imaging Description Measure #10: Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive Measure #11: CT Images Available for Patient Follow-up and Comparison Purposes Measures addressing pediatric patient safety Measure #7: Equipment Evaluation for Pediatric CT Imaging Protocols Measure #8: Utilization of Pediatric CT Imaging Protocols Please note: Measures 4-6 of this project have been deleted. These clinical performance measures are designed for practitioner-level quality improvement and as a step in the journey towards achieving better outcomes for patients by optimizing patient exposure to ionizing radiation. Unless otherwise indicated, the measures are also appropriate for accountability if the appropriate methodological, statistical, and implementation rules are achieved. Distinction between Measures for Accountability and Quality Improvement or Measures for Quality Improvement Only Measures developed for accountability, including those for use in public reporting, accreditation and possibly pay-for-performance, must meet certain criteria to warrant the designation. In particular, measures must be developed through a rigorous process that includes a public comment and peer review period, be based on guideline recommendations that were prioritized because of the clinical importance of the intervention and link to desired outcomes, the strength of evidence and strength of recommendation, gaps in care, validity, and feasibility. Other Potential Measures The Work Group considered several other important constructs related to the optimization of patient exposure to ionizing radiation, though ultimately determined that they were not suitable in the context of this performance measurement project. In particular, there was universal agreement among Work Group members that CT imaging was not the only ionizing radiology imaging modality of concern; rather, the use of interventional radiology procedures and various types of nuclear medicine studies © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 6 also may contribute to high radiation dose exposure. Despite the importance and the frequent use of these procedures, the Work Group opted to narrow its efforts and focus primarily on CT for this measure development project. The Work Group also focused one measure on myocardial perfusion studies given that these are the imaging studies with the single highest radiation burden.3 Measure Harmonization When existing hospital- or plan-level measures are available for the same measurement topics, the PCPI attempts to harmonize the measures to the extent feasible. To address potential opportunities for harmonization, the following measures were reviewed: NQF measure #0739: Radiation Dose of Computed Tomography (CT). NQF measure #0740: Participation in a Systematic National Dose Index Registry. NQF measure #0510: Exposure time reported for procedures using fluoroscopy. Technical Specifications Overview There are several data sources available for collecting performance measures; generally different data sources require different sets of measure specifications, due to the structure of the systems storing the data. The PCPI is focusing significant resources and expertise toward specifying and testing measures within EHRs and other Health Information Technology systems, as they hold the promise of providing the relevant clinical data for measures and for providing feedback to physicians and other health care providers that is timely and actionable. This performance measurement set has been put forward for PCPI vote without specifications. The measures are not intended for implementation until the development of specifications is completed as set forth in the following plan: • Six of the measures included in this set have been included in the 2013 Medicare Physician Fee schedule and were finalized for inclusion in the 2014 Physician Quality Reporting System (PQRS) as a Measures Group, effective January 1, 2014. AMA professional staff to the PCPI will coordinate with the CMS contractor for the PQRS program to develop specifications for these measures to be used in the PQRS program. These five measures are listed below: - Measure #1: Reporting to a Radiation Dose Index Registry - Measure #2: Utilization of a Standardized Nomenclature for CT Imaging Description - Measure #3: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines - Measure #9: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies - Measure #10: Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive - Measure #11: CT Images Available for Patient Follow-up and Comparison Purposes • AMA professional staff to the PCPI will coordinate with ABMS, ACR, and the American Board of Radiology to identify other implementations of these measures, such as in a Practice Quality Improvement (PQI) project as part of Maintenance of Certification. Testing and Implementation of the Measurement Set The measures in this set are being made available without any prior formal testing. However, many of the measures in this set (Utilization of a Standardized Nomenclature for CT Imaging Description, Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies, CT Images Available for Patient Follow-Up and Comparison Purposes, Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive, Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines and Reporting to a Radiation Dose Index Registry) have been in use in the CMS Physician Quality Reporting System program since 2013 indicating the feasibility of collecting the data elements required for measure calculation. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 7 The American College of Radiology recognizes the importance of thorough testing all of its measures and encourages ongoing robust testing of the Optimizing Patient Exposure to Ionizing Radiation measurement set for feasibility and reliability by organizations or individuals positioned to do so. The ACR will welcome the opportunity to promote such testing of these measures and to ensure that any results available from testing are used to refine the measures on an ongoing basis. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 8 © 2013 American Medical Association and American Board of Medical Specialties. All Rights Reserved 9 Optimizing Patient Exposure to Ionizing Radiation Performance Measurement Set P u r p o s e of M e a s u r e m e n t S e t The American Board of Medical Specialties (ABMS) and the American Medical Association (AMA)convened Physician Consortium for Performance Improvement® (PCPI®) in collaboration with the American Board of Radiology (ABR) and the American College of Radiology (ACR) formed an Optimizing Patient Exposure to Ionizing Radiation (OPEIR) Work Group. The intent of the Work Group was to identify and define quality measures toward improving the quality of care for patients undergoing high dose radiation imaging studies and for use in Physician Quality Improvement (PQI) projects for implementation into Maintenance of Certification® (MOC) Part IV programs. The measures in this project address radiation exposure across a continuum – before, during and after an imaging procedure. Measures intended for use before address the appropriateness of the exam, measures intended for use during address the technical aspects of the exam and those intended for use after radiological imaging address coordination and utilization of available images. The Work Group aimed to develop a set of measures that support the efficient delivery of high quality health care in each of the Institute of Medicine’s (IOM) six aims for quality improvement (safe, effective, patient centered, timely, efficient, and equitable). 6 While the Work Group focused on developing measures that reflect the most rigorous clinical evidence available and address areas most in need of performance improvement, several measures have been developed to advance clinical practice through the use of health information technology (HIT). Therefore, emerging standards, enhanced data storage and transmission abilities and the Health Information Technology for Economic and Clinical Health (HITECH) Act form the basis for the HITrelevant measures. These measures aim to use HIT to improve the quality of health care, reduce medical errors, increase appropriateness of ionizing radiation procedures, and improve the continuity of care within and between healthcare settings. The Work Group considered opportunities for outcome, process and structure measures as well as composite, bundled and group- or system-level measures. Importance of Topic The use of medical imaging has resulted in revolutionary advances in the practice of medicine. The increased sophistication and clinical efficacy of imaging have resulted in its considerable growth. Consequently, the evolution of imaging has resulted in a significant increase in the population’s cumulative exposure to ionizing radiation and a potential increase in adverse effects including cancer. 7,8 Although experts may not agree on the extent of the risks of cancer from medical imaging, there is uniform agreement that care should be taken to weigh the medical necessity of a given level of radiation exposure against the risks, and that steps should be taken to eliminate avoidable exposure to radiation.8,9 High Impact Topic Area This topic was chosen for measure development because of the high costs associated with imaging studies and because these medical procedures are a significant source of radiation exposure. The following objective data support the degree of increase in the use of imaging studies and emphasize the importance in taking steps to help eliminate avoidable exposure. Prevalence and Incidence • • The average per capita exposure to ionizing radiation from imaging exams increased by about 600% from 1980 to 2006 in the United States.1,2 The largest contributor to this dramatic increase in population radiation exposure is the computed tomography (CT). In 1980 fewer than 3 million CT scans were performed; In 2006, there were about 380 million radiologic procedures (including 67 million CT scans) and 18 million nuclear medicine procedures performed in the United States.1 © 2013 American Medical Association and American Board of Medical Specialties. All Rights Reserved 10 • • • • • The imaging study with the single highest radiation burden, accounting for 22% of cumulative effective dose is myocardial perfusion imaging.3 In 2006, an estimated 19 million head, 10.6 million chest and 21.2 million abdominal and pelvic CT scans were performed accounting for 28, 15.9, and 31.7 percent, respectively, of the total number of CT scans in the US.1 Currently, approximately 11% of CT examinations are performed on children, which could account for more than 7 million pediatric CT examinations per year in the United States. 10,11,12 The prevalence of CT or MRI use during emergency department visits for injury-related conditions increased from 6% in 1998 to 15% in 2007. 13 While CT utilization has decreased steadily since 2003 in pediatric facilities across North America, 14 the use of CT in children who visit the ED increased from 0.33 to 1.65 from 1995 to 2008 and occurred primarily at non-pediatric focused facilities. 15 Costs • • • From 2000 through 2006, total Medicare expenditures for physician imaging services increased from $6.7 billion to about $14 billion, an increase of 13 percent per year on average.5 In 2005 imaging services represented an estimated 14 percent of 2005 spending included in the sustainable growth rate (SGR) calculation, but represented 27 percent of the total increase in such spending between 2004 and 2005. The majority of the growth occurred for advanced imaging.5 In 2006, advanced imaging, including CT and MRI, accounted for 54 percent of total Medicare imaging expenditures, up from 43 percent in 2000. This translates to an increase in Medicare spending on advanced imaging from about $3 billion in 2000 to about $7.6 billion in 2006.5 Disparities There is variation according to age, sex, and health care market in the proportion and mean dose of patients undergoing medical imaging procedures. One study concluded that the proportion of subjects undergoing at least one imaging procedure was higher in older patients, rising from 49.5% of those who were 18 to 34 years old to 85.9% of those who were 60 to 64 years old. The study also found that women underwent procedures significantly more often than men, with a total of 78.7% of women undergoing at least one procedure during the study period, as compared with 57.9% of men.3 O p p o r t u n i t y f or I m p r o v e m e n t One retrospective cross-sectional study describing radiation dose associated with some of the most common types of diagnostic CT found variable radiation doses. The study found variability in the following exams: 1) Routine chest exam without contrast, the CT Effective Doses ranged from 2mSv to 24mSv; 2) Routine abdomen-pelvis, no contrast - CT Effective Dose ranged from 3mSv to 43mSv; 3) Routine head exam - CT Effective Dose ranged from 0.3mSv to 6mSv. 16 Clinical Evidence Base Clinical practice guidelines serve as the foundation for the development of performance measures. A number of clinical practice guidelines have been developed for the optimization of radiology imaging based on exam modality and body part, offering an evidence base to guide clinical decision-making and performance measure development. Guidelines from these organizations were reviewed during the measure development process: 1. American College of Radiology 2. National Cancer Institute 3. National Council on Radiation Protection and Measurements © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 11 Additional recommendations from the Fleischner Society, the Alliance for Radiation Safety in Pediatric Imaging Guidelines and other groups that focused on specific dimensions related to radiology imaging were also incorporated. Relevant guidelines met all of the required elements and many, if not all, of the preferred elements outlined in a PCPI position statement establishing a framework for consistent and objective selection of clinical practice guidelines from which PCPI Work Groups may derive clinical performance measures. 17 Performance measures, however, are not clinical practice guidelines and cannot capture the full spectrum of care for all patients undergoing ionizing radiation imaging. The OPEIR Work Group attempted to use guideline principles with the strongest recommendations and often the highest level of evidence as the basis for measures in this set; however, due to the paucity of research related to radiation exposure, the Work Group relied on those practice parameters and guidelines that are most widely used in clinical practice. Optimizing Patient Exposure to Ionizing Radiation O u t c om e s Ideally, a set of performance measures would include measures of outcomes as well as key process and structural measures known to positively influence desirable outcomes. The development of outcome measures for optimizing patient exposure to ionizing radiation proved particularly challenging because of the cumulative and potentially latent effects of radiation. In light of these difficulties, the Work Group set out to develop performance measures based on structures and processes that will achieve desired outcomes and reflect high quality care. Desirable outcomes for optimizing patient exposure to ionizing radiation include: 1. Reducing patient harm 2. Reducing excessive radiation risks and exposures 3. Reducing procedural complications 4. Reducing morbidity in patients who undergo radiology imaging and/or radiation dosing 5. Reducing inappropriate and/or unnecessary repeat imaging 6. Encouraging recording of medical imaging exam radiation dose indices and reporting of patient-level tracking of imaging exams conducted 7. Enhancing awareness of risks associated with medical imaging 8. Encouraging appropriate utilization of ionizing and nonionizing radiation I n t e n d e d A u d i e n c e , C a r e S e t t i n g , a n d P a t i e n t P o p u l a t i on ABMS and the PCPI encourage the use of these measures by physicians, other healthcare professionals, and healthcare systems, or health plans, to manage the care for patients undergoing radiation imaging studies in the Emergency Department, or within Inpatient or Ambulatory care. These clinical performance measures are designed for implementation into MOC programs to satisfy Part IV requirements and practitioner- and/or system-level quality improvement to achieve better outcomes for patients undergoing radiologic imaging. Unless otherwise indicated, the measures are also appropriate for accountability if the appropriate methodological, statistical, and implementation rules are achieved and their original relationship to the MOC process is recognized. Performance measurement serves as an important component in a quality improvement strategy but performance measurement alone will not achieve the desired goal of improving patient care. Measures can have the greatest effect when used judiciously and linked directly to operational steps that clinicians, patients, and health plans can apply in practice to improve care. To that end, the PCPI will work with quality improvement collaboratives and other initiatives to ensure that these measures are implemented with the goal of improved patient care. Optimizing Patient Exposure to Ionizing Radiation W or k G r ou p R e c o m m e n d a t i o n s The Optimizing Patient Exposure to Ionizing Radiation (OPEIR) Work Group considered a wide range of measurement opportunities focusing on a variety of imaging modalities – CT, fluoroscopy, perfusion © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 12 scan, nuclear medicine and interventional radiology – and varying anatomical areas of the body, head, abdomen, pelvis and lungs. The Work Group concluded that this measure development project would primarily focus on the use of CT and on myocardial perfusion studies which are considered some of the largest contributors to population radiation exposure.1,3 The key priorities of this measurement set are to improve the effectiveness of care and optimize patient exposure as the use of ionizing radiology procedures grow. The OPEIR Work Group identified several desired outcomes for patients undergoing high radiation dose imaging procedures (see “Link to Outcomes” diagram in preceding section). Current quality gaps among imaging equipment, institutional processes and overuse of imaging for low-risk populations need to be critically evaluated to improve ionizing radiation outcomes (ie, the evaluation and monitoring of low-risk patient populations, safety interventions, and the standardization and sharing of images). As a result, many of the measures in the Optimizing Patient Exposure to Ionizing Radiation set focus on the provision of safe, effective and efficient patient-centered care. These clinical performance measures are designed for practitioner-level quality improvement to achieve better outcomes for patients undergoing high radiation dose imaging. Unless otherwise indicated, the measures are also appropriate for accountability if the appropriate methodological, statistical, and implementation rules are achieved. The measures listed below may be used for quality improvement and accountability. Process measures: Several key processes of care designed to improve outcomes for patients undergoing ionizing radiation imaging are recommended: Measures addressing safety, efficiency and appropriateness Measure #3: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines Measure #9: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies Structural measures: Several structural measures, designed to reduce unnecessary or repeat imaging and radiation exposure through the use of protocols and health information technology are recommended: Measures addressing the recording and reporting of imaging procedures Measure #1: Reporting to a Radiation Dose Index Registry Measure #2: Utilization of a Standardized Nomenclature for CT Imaging Description Measure #10: Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive Measure #11: CT Images Available for Patient Follow-up and Comparison Purposes Measures addressing pediatric patient safety Measure #7: Equipment Evaluation for Pediatric CT Imaging Protocols Measure #8: Utilization of Pediatric CT Imaging Protocols Please note: Measures 4-6 of this project have been deleted. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 13 These measures support the efficient delivery of high quality health care in many of the IOM’s six aims for quality improvement as described in the following table: IOM Domains of Health Care Quality Draft Measures 1 Reporting to a Radiation Dose Index Registry 2 Utilization of a Standardized Nomenclature for CT Imaging Description Safe IOM Domains of Health Care Quality Safe 3 Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines Effective Underuse Overuse Patientcentered Timely Effective Overuse Equitable Underuse Efficient Patientcentered Timely Efficient Equitable Measures 4-6 deleted 7 8 9 10 11 Equipment Evaluation for Pediatric CT Imaging Protocols Utilization of Pediatric CT Imaging Protocols Count of Potential High Dose Radiation Imaging Studies: CT and Cardiac Nuclear Medicine Studies Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive CT Images Available for Patient Follow-Up and Comparison Purposes © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 14 Other Potential Measures The OPEIR Work Group considered several other important constructs related to optimizing patient exposure to ionizing radiation, though ultimately determined that they were not suitable in the context of this performance measurement project. In particular, there was universal agreement among Work Group members that CT imaging was not the only high radiation dose imaging modality of concern; rather, the use of interventional radiology procedures and nuclear medicine studies also contribute greatly to high radiation dose exposure. Despite the importance and the frequent use of these procedures, the Work Group made the decision to narrow its efforts and focus primarily on CT studies. The Work Group also focused one measure on myocardial perfusion studies given that these are the imaging studies with the single highest radiation burden.3 The Work Group also discussed broadening the scope of this project to include imaging related to anatomical areas other than the head, abdomen and/or pelvis and lungs. These discussions focused on the overuse of CT imaging for renal colic, hepatic hemangiomas, and trauma and to rule out disease of the abdomen. Again, to maintain a more focused measurement set, development outside of the proposed set was limited. Q u a l i t y I m p r ov e m e n t M e a s u r e s / A d d i t i o n a l M e a s u r e s R e f e r e n c e d ( M e a s u r e s N ot D e v e l o p e d b y A B M S / A B R / A C R / P C P I U n d e r T h i s P r o j e c t ) The Work Group discussed existing overuse quality improvement measures that may be implemented at the site- or system-level if appropriate for accountability purposes. Implementation at this level would more accurately reflect the actionability of practice ordering patterns, rather than maintain a focus on point of imaging service. Two measures of this type, not developed under this project, are referenced in this measure set, Measure #13 (Partners HealthCare/Brigham & Women’s Hospital): Pulmonary CT Imaging for Patients at Low-risk for Pulmonary Embolism and Measure #14 (Partners HealthCare/Brigham & Women’s Hospital): Appropriate Head CT Imaging in Adults with Mild Traumatic Brain Injury. These measures are referenced in this set as quality improvement measures that may be implemented by a radiologist in an MOC Part IV project as an opportunity to optimize radiation dose through appropriate imaging. Both measures were endorsed by the National Quality Forum (NQF) in April 2011. Full descriptions and specifications for these Partners HealthCare/Brigham & Women’s Hospital measures are available at: http://www.brighamandwomens.org/Research/labs/cebi/bestcare/HowDoWeAvoid.aspx#quality A third measure, Exposure Time Reported for Procedures Using Fluoroscopy, previously developed by PCPI/ACR/NCQA for its Radiology Measure set, and NQF-endorsed® has also been referenced in this measure set as a potential MOC Part IV project. The Radiology measure set is available at: http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit=PCPI. Other related measures not discussed by the work group may be available for implementation. Measure Harmonization When existing hospital- or plan-level measures are available for the same measurement topics, the PCPI attempts to harmonize the measures to the extent feasible. To address potential opportunities for harmonization, the following measures were reviewed: NQF measure #0739: Radiation Dose of Computed Tomography (CT) is intended for the quantification and reporting of radiation dose associated with CT examinations of the head, neck, chest, abdomen/pelvis and lumbar spine, obtained in children and adults. NQF measure #0740: Participation in a Systematic National Dose Index Registry, is an attestation measure specifically requiring the use of a national, registry with systematic and automated data collection. NQF measure #0510: Exposure time reported for procedures using fluoroscopy, focuses on radiation exposure related to fluoroscopic and not CT imaging. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 15 Technical Specifications: Overview Technical Specifications Overview There are several data sources available for collecting performance measures; generally different data sources require different sets of measure specifications, due to the structure of the systems storing the data. The PCPI is focusing significant resources and expertise toward specifying and testing measures within EHRs and other Health Information Technology systems, as they hold the promise of providing the relevant clinical data for measures and for providing feedback to physicians and other health care providers that is timely and actionable. This performance measurement set has been put forward for PCPI vote without specifications. The measures are not intended for implementation until the development of specifications is completed as set forth in the following plan: • Six of the measures included in this set have been included in the 2013 Medicare Physician Fee schedule and were finalized for inclusion in the 2014 Physician Quality Reporting Program as a Measures Group, effective January 1, 2014. AMA professional staff to the PCPI will coordinate with the CMS contractor for the PQRS program to develop specifications for these measures to be used in the PQRS program. These five measures are listed below: - Measure #1: Reporting to a Radiation Dose Index Registry - Measure #2: Utilization of a Standardized Nomenclature for CT Imaging Description - Measure #3: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines - Measure #9: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies - Measure #10: Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive - Measure #11: CT Images Available for Patient Follow-up and Comparison Purposes AMA professional staff to the PCPI will coordinate with ABMS, ACR, and the American Board of Radiology to identify other implementations of these measures, such as in a Practice Quality Improvement (PQI) project as part of Maintenance of Certification. • Measure Exclusions and Measure Exceptions Measure Exclusions Exclusions arise when patients who are included in the initial patient or eligible population for the measure set do not meet the denominator criteria specific to the intervention required by the numerator. Exclusions are absolute and apply to all patients and therefore are not part of clinical judgment within a measure. Specific exclusions should be derived from evidence-based guidelines. Measure Exceptions In the context of physician performance measurement, exceptions are the mechanism used to remove patients from the denominator of a performance measure when a patient does not receive a therapy or service AND that therapy or service would not be appropriate due to specific reasons for which the patient would otherwise meet the denominator criteria. Exceptions are not absolute, and are based on clinical judgment and individual patient characteristics. For process measures, the PCPI provides three categories of reasons for which a patient may be excluded from the denominator of an individual measure: • Medical reasons Includes: - not indicated (absence of organ/limb, already received/performed, other) - contraindicated (patient allergic history, potential adverse drug interaction, other) © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 16 • Patient reasons Includes: - patient declined - social or religious reasons - other patient reasons • System reasons Includes: - resources to perform the services not available - insurance coverage/payor-related limitations - other reasons attributable to health care delivery system These measure exception categories are not available uniformly across all measures; for each measure, there must be a clear rationale to permit an exception for a medical, patient, or system reason. For some measures, examples have been provided in the measure exception language of instances that would constitute an exception. Examples are intended to guide clinicians and are not all-inclusive lists of all possible reasons why a patient could be excluded from a measure. One mechanism to report an exception of a patient is by appending the appropriate modifier to the CPT Category II code designated for the measure: • • • Medical reasons: modifier 1P Patient reasons: modifier 2P System reasons: modifier 3P Although this methodology does not require the external reporting of more detailed exception data, the PCPI recommends that physicians document the specific reasons for exception in patients’ medical records for purposes of optimal patient management and audit-readiness. The PCPI also advocates the systematic review and analysis of each physician’s exceptions data to identify practice patterns and opportunities for quality improvement. For example, it is possible for implementers to calculate the percentage of patients that physicians have identified as meeting the criteria for exception. Please refer to documentation for each individual measure for information on the acceptable exception categories and the codes and modifiers to be used for reporting. The full position statement 18 that discusses exclusions/exceptions and their use may be accessed through the PCPI website (www.physicianconsortium.org). T e s t i n g a n d I m p l e m e n t a t i o n of t h e M e a s u r e m e n t S e t The measures in this set are being made available without any prior formal testing. However, many of the measures in this set (Utilization of a Standardized Nomenclature for CT Imaging Description, Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies, CT Images Available for Patient Follow-Up and Comparison Purposes, Search for Prior CT Studies through a Secure, Authorized, Media-free, Shared Archive, Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines and Reporting to a Radiation Dose Index Registry) have been in use in the CMS Physician Quality Reporting System program since 2013 indicating the feasibility of collecting the data elements required for measure calculation. The American College of Radiology recognizes the importance of thorough testing all of its measures and encourages ongoing robust testing of the Optimizing Patient Exposure to Ionizing Radiation measurement set for feasibility and reliability by organizations or individuals positioned to do so. The ACR will welcome the opportunity to promote such testing of these measures and to ensure that any results available from testing are used to refine the measures on an ongoing basis. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 17 Measure #1: Reporting to a Radiation Dose Index Registry Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of total computed tomography (CT) studies performed for all patients, regardless of age, that are reported to a radiation dose index registry AND that include at a minimum selected data elements M e a s u r e C om p o n e n t s Numerator Statement CT studies performed that are reported to a radiation dose index registry AND that include at a minimum all of the following data elements*: Manufacturer Study description Manufacturer’s model name Patient’s weight Patient’s size Patient’s sex Patient’s age Exposure time X-Ray tube current Kilovoltage (kV) Mean Volume Computed tomography dose index (CTDIvol) Dose-length product (DLP) *Detailed information regarding the patient demographic and scanner data elements included in the Digital Imaging and Communication in Medicine (DICOM) header and CT irradiation event data elements included in the DICOM Supplement 127: CT Radiation Dose Reporting (Dose Structured Report) can be found in the Dose Index Registry Data Dictionary available on the American College of Radiology (ACR) Web site: Dose Index Registry Data Dictionary Denominator Statement All CT studies performed for all patients, regardless of age Denominator Exceptions None. Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines: The goal in medical imaging is to obtain image quality consistent with the medical imaging task. Diagnostic reference levels are used to manage the radiation dose to the patient. The medical radiation exposure must be controlled, avoiding unnecessary radiation that does not contribute to the clinical objective of the procedure. By the same token, a dose significantly lower than the reference level may also be cause for concern, since it may indicate that adequate image quality is not being achieved. The specific purpose of the reference level is to provide a benchmark for comparison, not to define a maximum or minimum exposure limit. 19 For CT, the diagnostic reference levels are based on the volume CT dose index (CTDI )19 vol Measure Importance Relationship Clinical registries have become an important tool in efforts to improve quality of © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 18 to desired outcome care. Registries provide a structured mechanism to monitor clinical practice patterns, evaluate healthcare effectiveness and safety, and evaluate patient outcomes. 20,21,22 Clinical registries like the ADHERE, Get with the Guidelines and the Advanced Cardiovascular Imaging Consortium registries, have been associated with performance improvement by registry participants.21,23,24,25 Establishing diagnostic reference levels is vital to helping clinicians determine optimal radiation dosage to produce acceptable image quality. A data registry such as the ACR Dose Index Registry (DIR) allows facilities to compare their CT dose indices to regional and national values enabling imaging providers and the imaging community to measure the effectiveness of dose lowering efforts over time. Reference levels are based on actual patient doses for specific procedures measured at a number of representative clinical facilities. The levels are set at approximately the 75th percentile of these measured data, meaning that the procedures are performed at most institutions with doses at or below the reference level. Consequently, reference levels are suggested action levels at which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses.19 A prospective, controlled, nonrandomized study using a cardiac computed tomography angiography registry found that consistent application of dosereduction techniques was associated with a reduction in estimated radiation doses without impairment of image quality.25 During the follow-up period, patients' estimated median radiation dose was reduced by 53% and effective dose from 21 mSv to 10 mSv as compared with the control period.25 Opportunity for Improvement A central database established for collecting dose indices as a function of patient qualities (ie, gender, age, size, etc.) and exam type (ie, lateral lumbar spine, pelvis CT, etc.), would allow the relative range of radiation dose indices to be analyzed and compared against established benchmarks. One retrospective cross-sectional study describing radiation dose associated with some of the most common types of diagnostic CT found variable radiation doses, highlighting the need for greater standardization.16 The study suggests variability in the following exams: Routine chest exam without contrast CT Effective Doses ranging from 2mSv to 24mSv Routine abdomen-pelvis, no contrast CT Effective Dose ranging from 3mSv to 43mSv Routine head exam CT Effective Dose ranging from 0.3mSv to 6mSv IOM Domains of Health Care Quality Addressed Exception Justification • • Safe Patient-centered • Efficient The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 19 Harmonization with Existing Measures NQF measure #0739: Radiation Dose of Computed Tomography (CT) is intended for the quantification and reporting of radiation dose associated with CT examinations of the head, neck, chest, abdomen/pelvis and lumbar spine, obtained in children and adults. NQF measure #0740: Participation in a Systematic National Dose Index Registry, is an attestation measure specifically requiring the use of a national, registry with systematic and automated data collection. NQF measure #510: Exposure time reported for procedures using fluoroscopy, focuses on radiation exposure related to fluoroscopic and not CT imaging. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Public reporting Structure Physician Physicist Provider Group* Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Documentation of original self-assessment Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry data Practice Quality Improvement Module *The American Board of Radiology’s Practice Quality Improvement Definition of "Group": Two or more physicians/physicists of the same or different specialties/subspecialties, sharing a common central organizational structure, who work together to provide patient care, regardless of individual contractual affiliations or relationships. These physicians/physicists may provide services at single or multiple facilities or locations in a variety of clinical settings, including hospitals, offices or patient imaging centers. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 20 Measure #2: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging Description Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature* and the standardized nomenclature is used in institution’s computer systems M e a s u r e C om p o n e n t s Numerator Statement CT imaging reports with the imaging study named according to a standardized nomenclature* and the standardized nomenclature is used in institution’s computer systems, including but not limited to: • • • • computerized physician ordering system charge master radiology information system electronic health record *Use of a standardized nomenclature is meant to enable reporting to a Dose Index Registry. There is no standard lexicon implemented across the board for naming CT exam procedures. To make like comparisons of sites reporting dose index data to a registry, it is necessary to use a specific CT exam name and standardize that across registry participants. Denominator Statement All CT imaging reports for all patients, regardless of age Denominator Exceptions None. Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and/or other references: The Lexicon-Enabled Radiology Practice 26 As images, imaging reports and medical records move online, radiologists need a unified language to organize and retrieve them. Radiologists currently use a variety of terminologies and standards, but no single lexicon serves all of their needs. The existence of a standardized lexicon for radiology enables numerous improvements in the clinical practice of radiology, starting with the ordering of imaging exams, through the use of information in the resulting radiology report. It also makes possible more effective reuse of information for research and educational purposes. Some specific uses of RadLex® terminology include: • Automatic order entry decision support. Because the names of imaging exams are described in consistent language, the applicability of appropriateness criteria developed by the ACR and others can be determined automatically. • Vendor independent "protocoling" of complex imaging exams. Imaging exam protocols for CT and MR exams can be specified using vendor independent language. Consistent names for imaging exams and procedure steps (eg, radiographic view, CT sequence, MR series) are used throughout the radiology practice. • Improved speech recognition accuracy. Because the exam descriptions are explicitly linked to the body site imaged and the modality used, speech © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 21 recognition systems use this linkage information to improve recognition accuracy. • Real-time decision support for the radiologist. Because standardized terms are associated with radiology reports, these terms can trigger decision support tools for the radiologist. Decision support systems automatically retrieve case-relevant information in real time, such as checklists for image features to seek, additional differential diagnoses, or information from PubMed, the Internet, and proprietary decision support databases. Measure Importance Relationship to desired outcome Promoting Effective Communication and Coordination of Care is one of the priorities in the National Strategy for Quality Improvement in Health care, with great potential for rapidly improving health outcomes and increasing the effectiveness of care for all populations. 27 A uniform structure for capturing, indexing, and retrieving a variety of radiology information may facilitate the structured reporting of radiology reports. This will also permit mining of data for participation in research projects, registries, and quality improvement efforts. 28 Standardized nomenclature may include RadLex®. Other standardized nomenclature may be available and would be acceptable for this measure. RadLex® is a controlled terminology for radiology—a single unified source of radiology terms that is designed to fill this need. The purpose of RadLex® is to provide a uniform structure for capturing, indexing, and retrieving a variety of radiology information sources, such as teaching files and research data. This may facilitate a first step toward structured reporting of radiology reports. This will also permit mining of data for participation in research projects, registries, patient outcomes and quality assurance. 29 Opportunity for Improvement IOM Domains of Health Care Quality Addressed Exception Justification Harmonization with Existing Measures Radiologists currently use a variety of terminologies and standards, but no single lexicon serves all of their needs.28 Terminology is increasingly vital to the practice of medicine. Many of the benefits of clinical information technology cannot be realized unless information is stored using standard terms in a structured format.28,30 • • • Safe Effective Efficient The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose • • • • Type of measure Level of Measurement • Structure • Physician • Physicist Accountability Quality improvement Maintenance of Certification® programs Public reporting © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 22 Care setting Data source • • • • • • • • • • • • • Provider Group Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Documentation of original self-assessment Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 23 Measure #3: Appropriateness: Follow-up Computed Tomography (CT) Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of final reports for computed tomography (CT) imaging studies of the thorax for patients aged 18 years and older with documented follow-up recommendations for incidentally detected pulmonary nodules (eg, follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors M e a s u r e C om p o n e n t s Numerator Statement Final reports with documented follow-up recommendations* for incidentally detected pulmonary nodules (eg, follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors *Definition Follow-up Recommendations: No follow-up recommended in the final CT report OR follow-up is recommended within a designated time frame in the final CT report. Recommendations noted in the final CT report should be in accordance with recommended guidelines. Denominator Statement All final reports for CT imaging studies of the thorax for patients aged 18 years and older with documented follow-up recommendations for incidentally detected pulmonary nodules (e.g., follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors Denominator Exceptions None. Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and/or other references: Fleischner Society Recommendations for Follow-up and Management of Nodules Smaller than 8mm Detected Incidentally at Nonscreening CT 31 Since the decision to perform follow-up studies relies on size, lesion characteristics (eg, morphology), and growth rates (typically described as doubling time), an understanding of these features and their relationship to malignancy should dictate further evaluation. In addition, the patient's risk profile, including age and smoking history, needs to be integrated into the diagnostic algorithm. Nodule size* ≤ 4 mm Low-Risk Patient: no follow-up needed† High-Risk Patient: follow-up at 12 months; if unchanged, no further follow-up‡ Nodule size >4-6 mm Low-Risk Patient: follow-up at CT at 12 months; if unchanged, no further followup‡ High-Risk Patient: initial follow-up CT at 6-12 months, then at 18-24 months if no change‡ Nodule size >6-8 mm Low-Risk Patient: initial follow-up CT at 6-12 months, then at 18-24 months if no change High risk Patient: initial follow-up CT at 3-6 months, then at 9-12 and 24 months if no change © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 24 Nodule size >8 mm Same for Low- or High-Risk Patient: follow-up CT at around 3, 9, and 24 months, dynamic contrast enhanced CT, PET, and/or biopsy Note – Newly detected indeterminate nodule in persons 35 years of age or older. Low-Risk Patient - minimal or absent history of smoking and of other known risk factors. High-Risk Patient - history of smoking or of other known risk factors. * Average of length and width. † The risk of malignancy in this category (<1%) is substantially less than that in a baseline CT scan of an asymptomatic smoker. ‡ Nonsolid (ground-glass) or partly solid nodules may require longer follow-up to exclude indolent adenocarcinoma. These recommendations apply only to adult patients with nodules that are “incidental” in the sense that they are unrelated to known underlying disease. The following examples describe patients for whom the above guidelines would not apply: • • • Patients known to have or suspected of having malignant disease. Patients with a cancer that may be a cause of lung metastases should be cared for according to the relevant protocol or specific clinical situation. Young patients. Primary lung cancer is rare in persons under 35 years of age (<1% of all cases), and the risks from radiation exposure are greater than in the older population. Therefore, unless there is a known primary cancer, multiple follow-up CT studies for small incidentally detected nodules should be avoided in young patients. Patients with unexplained fever. In certain clinical settings, such a patient presenting with neutropenic fever, the presence of a nodule may indicate active infection, and short-term imaging follow-up or intervention may be appropriate. Previous CT scans, chest radiographs, and other pertinent imaging studies should be obtained for comparison whenever possible, as they may serve to demonstrate either stability or interval growth of the nodule in question. A low-dose, thin-section, unenhanced technique should be used, with limited longitudinal coverage, when follow-up of a lung nodule is the only indication for the CT examination. SOURCE: MacMahon H, Austin JHM, Gamsu G, et al. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology 2005; 237: 395-400. Measure Importance Relationship to desired outcome Pulmonary nodules are commonly encountered in both primary care and specialty settings.31,33 Pulmonary nodules require appropriate management to avoid missing early malignancies or conversely subjecting patients to unnecessary follow-up scans.33 At least 99% of all nodules 4mm or smaller are benign and because such small opacities are common on thin-section CT scans, follow-up CT is not recommended. 32 Additionally, there is no conclusive evidence that serial CT © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 25 studies with early intervention for detected cancers can reduce disease-specific mortality, even in high-risk patients. Therefore, follow-up CT for every small indeterminate nodule is not recommended.31 Opportunity for Improvement Pulmonary nodules have been identified in 8 up to 51% of individuals at the time of baseline low-dose CT screening. 33,34 Compared with larger nodules, nodules that measure < 8 to 10 mm in diameter are much less likely to be malignant and typically defy accurate characterization by imaging tests.33 One study found no cancer in patients in whom the largest noncalcified nodule detected at initial CT was less than 5.0 mm in diameter. Thus there was no advantage in performing short-interval follow-up for nodules smaller than 5 mm in their study, even in high-risk patients. 35 IOM Domains of Health Care Quality Addressed Exception Justification Harmonization with Existing Measures Because of the high frequency with which small pulmonary nodules are detected by CT, the number of resultant follow-up scans is a substantial source of patient anxiety, radiation exposure, and medical cost.34 • • Safe Effective • Efficient The Optimizing Patient Exposure to Ionizing Radiation Work Group opted to include a medical reason exception so that clinicians can justifiably exclude the documentation of follow-up recommendations for incidental pulmonary nodule(s) (eg, patients with known malignant disease, patients with unexplained fever). Additionally, the focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • Accountability Quality improvement Maintenance of Certification® programs Process • • • • • • • • • • • • Physician Provider Group Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 26 Measures 4-6 deleted © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 27 Measure #7: Equipment Evaluation for Pediatric CT Imaging Protocols Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of pediatric CT imaging studies for patients aged 17 years and younger performed with equipment that has complied with a CT equipment evaluation protocol at least once within the 12month period prior to the exam M e a s u r e C om p o n e n t s Numerator Statement Pediatric CT imaging studies performed with equipment that has complied with a CT equipment evaluation protocol* at least once within a 12-month period prior to the exam *CT equipment evaluation protocol should include at a minimum all of the following documented components: • Evaluation date of CT imaging equipment • Measurements of CT dose index values of commonly used imaging protocols or of other dosimetric metrics performed and compared to the vendor displays values • Prepared tables of patient radiation absorbed dose for representative protocol exams (eg, head, thorax, abdomen and pelvis) supplied to facility • Established radiation doses for pediatric patients by “child-sizing” CT scanning parameters • Dose recording and reduction technologies installed in equipment if available Denominator All pediatric CT imaging studies for patients aged 17 years and younger Statement Denominator Documentation of medical reason(s) for not performing studies with equipment that Exceptions has complied with a CT equipment evaluation protocol (eg, CT studies performed for radiation treatment planning or image-guided radiation treatment delivery) Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and/or other references: Advances in technology continually change the design and capabilities of CT scanners, even from the same manufacturer and certainly from different manufacturers. Each CT scanner requires a unique protocol development to optimize dose savings. Image GentlySM Ten Steps to Lower CT Radiation Dose for Patients While Maintaining Image Quality 36 1. Increase awareness and understanding of CT radiation dose issues among radiologic technologists. 2. Enlist the services of a qualified medical physicist. 3. Obtain accreditation from the American College of Radiology for your CT program. 4. When appropriate, use an alternative imaging strategy that does not use ionizing radiation. 5. Determine if the ordered CT is justified by the clinical indication. 6. Establish baseline radiation dose for adult-sized patients. 7. Establish radiation doses for pediatric patients by “child-sizing” CT scanning parameters. 8. Optimize pediatric examination parameters: a. Center the patient in the gantry, b. Reduce doses during projection scout (topogram) views, c. Axial versus helical mode, © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 28 d. Reduce detector size in z direction during acquisition, e. Adjust the product of tube current and exposure time, f. When to adjust the kilovoltage, g. Increase pitch, and h. Manual or automatic exposure control. 9. Scan only the indicated area: scan once. 10. Prepare a child-friendly and expeditious CT environment. The Image GentlySM guidelines are available at: http://www.pedrad.org/associations/5364/ig/index.cfm?page=614. Performance Monitoring of CT Equipment - Patient Radiation Dose 37 1. Evaluate at least yearly. 2. Measurements of CT dose index values of commonly used imaging protocols or of other dosimetric metrics should be performed and compared to the vendor displays values. 3. Prepare tables of patient radiation absorbed dose for representative protocol exams (eg, head, thorax, abdomen and pelvis) and supplied to facility. 4. Compare results with appropriate guidelines or recommendations when available. Measure Importance Relationship to desired outcome Radiation exposure is a concern in both adults and children. However, there are three unique considerations in children. 1. Children are considerably more sensitive to radiation than adults, as demonstrated in epidemiologic studies of exposed populations. 2. Children have a longer life expectancy than adults, resulting in a larger window of opportunity for expressing radiation damage. 3. Children may receive a higher radiation dose than necessary if CT settings are not adjusted for their smaller body size. 38 Advances in technology continually change the design and capabilities of CT scanners, even from the same manufacturer and certainly from different manufacturers. Each CT scanner requires a unique protocol development to optimize dose savings.36 Substantial dose reduction and high compliance can be obtained with pediatric CT protocols tailored to clinical indications, patient weight, and number of prior studies. 39 Opportunity for Improvement Currently, approximately 11% of CT examinations are performed on children, which could account for more than 7 million pediatric CT examinations per year in the United States.10,11,12 While CT utilization has decreased steadily since 2003 in pediatric facilities across North America,14 the use of CT in children who visit the ED increased from 0.33 to 1.65 from 1995 to 2008 and occurred primarily at non-pediatric focused facilities.15 IOM Domains of Health Care Quality Addressed • • Safe Effective • • Patient-centered Efficient © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 29 Exception Justification The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with Existing Measures Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Structure Physician Provider Group Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 30 Measure #8: Utilization of Pediatric CT Imaging Protocols Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of pediatric CT imaging studies for patients aged 17 years and younger performed with individualized equipment evaluation protocols that comply with a widely used guideline M e a s u r e C om p o n e n t s Numerator Statement Pediatric CT imaging studies performed with individualized equipment evaluation protocols* that comply with a widely used guideline *Equipment evaluation protocols should include at a minimum the following two documented components: • Baseline techniques for an adult head and abdomen CT • Determine the appropriate mAs for a pediatric thorax, abdomen and head CT Denominator Statement All pediatric CT imaging studies for patients aged 17 years and younger Denominator Exceptions Documentation of medical reason(s) for not performing CT studies with individualized equipment evaluation protocols (eg, CT studies performed for radiation treatment planning or image-guided radiation treatment delivery) Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and/or other references: Because children are more sensitive than adults to the effects of ionizing radiation, it is particularly important to tailor CT examinations to minimize exposure while providing diagnostic quality examinations. 40 Image Gently SM – How to Develop CT Protocols for Children40 The Image Gently instructions to develop pediatric CT protocols are available at http://www.pedrad.org/associations/5364/ig/?page=598. These instructions provide guidance in either developing CT protocols for children or verifying that your current protocols are appropriate. You may be able to reduce doses to a greater degree for high contrast studies. Calculation of the effective dose – Pediatrics (newborn to age 15) 41 • The effective dose in CT is derived from the dose-length product Effective dose calculation: E = k DLP k = age and body region-specific conversion coefficient (mSv mGy-1 cm-1) Pediatric Abdominal CT 42 • Scanning parameters should be optimized to obtain diagnostic image quality while adhering to the ALARA principle. • Scan area should be minimized according to the clinical indication. • Scanning parameters, including kVp, tube current, and exposure time (mAs), should be changed according to body size, area of interest, and clinical indication. May be achieved by using weight based tables or by using automatic exposure control (see Image Gently™ protocols. • Testicles should not be included the scanned area unless absolutely necessary for the clinical indication. Consideration should be given to shielding superficial structures in the scan region such as the testes. • If precontrast images are needed solely to determine whether calcification is © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 31 present, these can be done with additional decrease in mAs. • Intravenous (IV) contrast is usually used in the CT evaluation of the pediatric abdomen, since vascular structures and internal organs are better visualized due to the paucity of body fat in many pediatric patients. Renal stone evaluation is an exception. A routine dose of 2mL/kg is generally used. Volume of contrast, rate of injection, scan delayed time, and hand/power injection should be determined according to the location, size, and type of IV access, the child’s body size, the underlying disease (eg, congestive heart failure), and the clinical indication. . • Enteric contrast may be sued in the CT evaluation of the pediatric abdomen. Exceptions would include renal stone protocol, CT angiography and acute trauma. • In evaluating suspected appendicitis, IV contrast is typically used, generally to avoid repeat examinations. Precontrast and delayed scans are not necessary, unless a renal anomaly requiring evaluation of the collecting system is identified. Some centers use oral or rectal contrast. If oral contrast is given, sufficient time should be allowed to elapse for the contrast to reach the right lower quadrant prior to scanning. • Postprocessing 2D reformations and 3D reconstructions or 3D volume rendering may be useful adjuncts in displaying the anatomy. To achieve acceptable clinical CT scans of body, the CT scanner should meet or exceed the following specifications: 1. Gantry rotation times: ≤ 2 seconds. 2. Slice thickness: ≤ 5 mm (≤ 2 mm is preferred). 3. Limiting spatial resolution: 8 lp/cm for ≥ 32 cm DFOV and ≥ 10 lp/cm for < 24 cm DFOV. 4. Table pitch: no greater than 2:1 for single-rowdetector helical scanners. Measure Importance Relationship to desired outcome Radiation exposure is a concern in both adults and children. However, there are three unique considerations in children. 1. Children are considerably more sensitive to radiation than adults, as demonstrated in epidemiologic studies of exposed populations. 2. Children have a longer life expectancy than adults, resulting in a larger window of opportunity for expressing radiation damage. 3. Children may receive a higher radiation dose than necessary if CT settings are not adjusted for their smaller body size. 43 Advances in technology continually change the design and capabilities of CT scanners, even from the same manufacturer and certainly from different manufacturers. Each CT scanner requires a unique protocol development to optimize dose savings.36 Substantial dose reduction and high compliance can be obtained with pediatric CT protocols tailored to clinical indications, patient weight, and number of prior studies.39 Opportunity for Improvement Currently, approximately 11% of CT examinations are performed on children, which could account for more than 7 million pediatric CT examinations per year in the United States.10,11,12 While CT utilization has decreased steadily since 2003 in pediatric facilities across North America,14 the use of CT in children who visit the ED increased from 0.33 to 1.65 from 1995 to 2008 and occurred primarily at non-pediatric focused facilities.15 © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 32 IOM Domains of Health Care Quality Addressed Exception Justification Harmonization with Existing Measures • • Safe Effective • • Patient-centered Efficient The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Structure Physician Provider Group Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 33 Measure #9: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in the 12-month period prior to the current study M e a s u r e C om p o n e n t s Numerator Statement CT and cardiac nuclear medicine (myocardial perfusion studies) imaging reports that document a count of known previous CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in the 12-month period prior to the current study Instructions: Physicians will need to document in the final report all known previous CT and cardiac nuclear medicine (myocardial perfusion) studies the patient has received in the 12-month period prior to the current study as a count that includes studies from the Radiology Information System, patient-provided radiological history or other source. Denominator Statement All CT and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age Denominator Exceptions None. Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines: Radiologists, medical physicists, radiologic technologists, and all supervising physicians have a responsibility to minimize radiation dose to individual patients, to staff, and to society as a whole, while maintaining the necessary diagnostic image quality.42,44,45 Importance Relationship to desired outcome Increased CT use has resulted in growing rates of repeat or multiple imaging. 46 Opportunity for Improvement According to the National Council on Radiation Protection (NCRP), the average per capita exposure to ionizing radiation from imaging exams increased by nearly 600% from 1980 to 2006 in the United States.1,2 Physicians may lack important information that could inform their decisions in ordering imaging exams that use ionizing radiation. Ordering physicians may not have access to patients’ medical imaging or radiation dose history. Due to insufficient information, physicians may unnecessarily order imaging procedures that have already been conducted.9 One retrospective cohort study reported median, mean, and maximum values for the study count were 10, 13, and 70 with cumulative CT doses of 91, 122, and 579 mSv within the 7.7 year study period.46 © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 34 Another study of patients with at least 3 visits to a tertiary care center within one year, determined a median of 15 procedures involving radiation exposure; of which 4 were high-dose procedures. 47 The imaging study with the single highest radiation burden, accounting for 22% of cumulative effective dose is myocardial perfusion imaging.3 IOM Domains of Health Care Quality Addressed Exception Justification Harmonization with Existing Measures • • Safe Patient-centered • Efficient The Optimizing Patient Exposure to Ionizing Radiation Work Group opted to include a medical reason exception so that clinicians can exclude patients for whom a count of previous CT and cardiac nuclear medicine (myocardial perfusion studies) studies may not be indicated or applicable for this measure. The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Process Physician Provider Group Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 35 Measure #10: Search for Prior Computed Tomography (CT) Studies through a Secure, Authorized, Media-free, Shared Archive Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient CT imaging studies completed at nonaffiliated external entities within the past 12-months and are available through a secure, authorized, media-free, shared archive prior to an imaging study being performed M e a s u r e C om p o n e n t s Numerator Statement Final reports of CT studies, which document that a search for DICOM format images was conducted for prior patient CT imaging studies completed at nonaffiliated external entities within the past 12-months and are available through a secure, authorized, media-free*, shared archive prior to an imaging study being performed *Definition Media-free: Radiology images that are transmitted electronically ONLY, not images recorded on film, CD, or other imaging transmittal form. Instructions: This measure is intended for reporting by facilities that have archival abilities through a shared archival system. Denominator Statement All final reports for CT studies performed for all patients, regardless of age Denominator Exceptions Due to system reasons search not conducted for DICOM format images for prior patient CT imaging studies completed at non-affiliated external healthcare facilities or entities within the past 12 months that are available through a secure, authorized, media-free, shared archive (e.g., non-affiliated external healthcare facilities or entities does not have archival abilities through a shared archival system) Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and/or other references: Core functional requirements for an Internet-based system for sharing medical records 48 (a) methods to ensure privacy and confidentiality of data; (b) capability to move and store large data files (eg, images) with the same efficiency and reliability as possible with small data files (eg, text); (c) construction of registries, which contain “knowledge” of all fragments of medical information (and their physical location) from all sources for a given patient; (d) an ability to match records and accurately reconcile patient identities without a common patient identifier; (e) a means to regulate access to data and audit the access; (f) a method for moving blocks of data from one location to another; and (g) a method to aggregate and consume the data at the point of care. Optimal patient care requires that care providers and patients be able to create, manage and access comprehensive electronic health records (EHRs) efficiently and securely The sharing of radiologic images has become a fundamental part of radiology services and is essential for delivering high-quality care. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 36 Integrating the Healthcare Enterprise (IHE) IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information The IHE Radiology Technical Framework, defines specific implementations of established standards to achieve integration goals that promote appropriate sharing of medical information to support optimal patient care. The IHE Radiology Technical Framework includes various Integration Profiles that provide a convenient way for both users and vendors to reference a subset of the functionality detailed in the IHE Technical Framework. The Cross-enterprise Document Sharing for Imaging (XDS-I) Integration Profile specifies actors and transactions that allow users to share imaging information across enterprises. This profile depends on the IHE IT Infrastructure CrossEnterprise Document Sharing (XDS) profile. XDS for Imaging (XDS-I) defines the information to be shared such as sets of DICOM instances (including images, evidence documents, and presentation states), diagnostic imaging reports provided in a ready-for-display. Cross-Document Sharing Work Flow 49 The basic workflow is as follows: A document such as an x-ray report is created and stored at the document source, perhaps an imaging center. In addition, a (redundant) copy is sent into the document repository for the affinity domain in which this imaging center is participating. Upon receiving the x-ray report, the document repository registers it with the document registry for that affinity domain. The document registry ensures that the document is assigned to the correct patient by transacting with the patient identity source, which may be using the PIX-PDQ profiles to reconcile the varying demographic data and medical record numbers that different systems assign to the same patient. Sometime (perhaps even years) later, the patient is seen by another healthcare provider at a remote site. The healthcare provider wishes to read the prior x-ray reports. This remote site participates in the same affinity domain and is now regarded as a document consumer. As such, it may query the document registry as to the existence of the prior reports and query the document repository to obtain the reports. Again, patient identity is reconciled and confirmed using the patient identity source and the relevant IHE actors and profiles. This scenario can be expanded to describe the sharing of many kinds of healthcare documents. There are also slight variations permitted in which some of the actors can be placed either within the affinity domain centrally or at one of the sites at which documents arise. Federal Register, Electronic Health Record Incentive Program 50 While the Federal Register, Electronic Health Record Incentive Program is not an evidence-based clinical guideline, the HITECH Act requires the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, increasing prevention and improving the continuity of care among health care settings. The Incentive program includes meaningful use objectives and associated measures that pertain to the use of EHRs to facilitate the availability and use of health information. Measure Importance Relationship to desired outcome The current radiology information systems in hospitals generally do not collect or report radiation exposures and the medical imaging devices that communicate with radiology information systems do not currently forward data on the radiation dose received by a patient from each such test. As a result, physicians © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 37 are uncertain of their patients’ cumulative exposure and lifetime attributable risk (LAR), which is problematic when assessing, prioritizing and discussing the risks and benefits associated with their patients’ clinical needs. 51 NQF’s Safe Practices for Better Healthcare-2009 Update: A Consensus Report was prepared incorporating the National Priorities Partnership six crosscutting priorities. Safe Practice 12: Patient Care Information addresses the lack of care continuum by not communicating critical patient information such as medical history, diagnostic test results, medications, treatments, and procedures. The Safe Practice Statement addressing this topic reads as follows, “Ensure that care information is transmitted and appropriately documented in a timely manner and in a clearly understandable form to patients and to all of the patient’s providers / professionals, within and between care settings, who need that information to provide continued care.” 52 Opportunity for Improvement IOM Domains of Health Care Quality Addressed It has been estimated that between $3 and $10 billion are wasted in the United States annually on unnecessary or duplicative imaging studies. Duplicative imaging procedures could be substantially reduced with improved access to existing imaging data. Additionally, universal access to existing imaging studies to retrieve relevant prior images could improve diagnostic specificity for radiologists and potentially further minimize recommendations for follow-up studies. 53 • • • Safe Effective Patient-centered • • • Timely Efficient Equitable Exception Justification The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with Existing Measures Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Structure Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 38 Measure #11: Computed Tomography (CT) Images Available for Patient Follow-Up and Comparison Purposes Optimizing Patient Exposure to Ionizing Radiation Measure Description Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated external healthcare facilities or entities on a secure, media free, reciprocally searchable basis with patient authorization for at least a 12-month period after the study M e a s u r e C om p o n e n t s Numerator Statement Final reports for CT studies, which document that DICOM format image data are available to non-affiliated external healthcare facilities or entities on a secure, media free*, reciprocally searchable basis with patient authorization for at least a 12-month period after the study *Definition Media-free: Radiology images that are transmitted electronically ONLY, not images recorded on film, CD, or other imaging transmittal form. Denominator Statement All final reports for CT studies performed for all patients, regardless of age Denominator Exceptions None. Supporting Guideline & Other References The following evidence statements are quoted verbatim from the referenced clinical guidelines and or other references.: Core functional requirements for an Internet-based system for sharing medical records48 (a) methods to ensure privacy and confidentiality of data; (b) capability to move and store large data files (eg, images) with the same efficiency and reliability as possible with small data files (eg, text); (c) construction of registries, which contain “knowledge” of all fragments of medical information (and their physical location) from all sources for a given patient; (d) an ability to match records and accurately reconcile patient identities without a common patient identifier; (e) a means to regulate access to data and audit the access; (f) a method for moving blocks of data from one location to another; and (g) a method to aggregate and consume the data at the point of care. Optimal patient care requires that care providers and patients be able to create, manage and access comprehensive electronic health records (EHRs) efficiently and securely The sharing of radiologic images has become a fundamental part of radiology services and is essential for delivering high-quality care. Integrating the Healthcare Enterprise (IHE) IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information The IHE Radiology Technical Framework, defines specific implementations of established standards to achieve integration goals that promote appropriate sharing of medical information to support optimal patient care. The IHE Radiology Technical Framework includes © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 39 various Integration Profiles that provide a convenient way for both users and vendors to reference a subset of the functionality detailed in the IHE Technical Framework. The Cross-enterprise Document Sharing for Imaging (XDS-I) Integration Profile specifies actors and transactions that allow users to share imaging information across enterprises. This profile depends on the IHE IT Infrastructure CrossEnterprise Document Sharing (XDS) profile. XDS for Imaging (XDS-I) defines the information to be shared such as sets of DICOM instances (including images, evidence documents, and presentation states), diagnostic imaging reports provided in a ready-for-display. Cross-Document Sharing Work Flow49 The basic workflow is as follows: A document such as an x-ray report is created and stored at the document source, perhaps an imaging center. In addition, a (redundant) copy is sent into the document repository for the affinity domain in which this imaging center is participating. Upon receiving the x-ray report, the document repository registers it with the document registry for that affinity domain. The document registry ensures that the document is assigned to the correct patient by transacting with the patient identity source, which may be using the PIX-PDQ profiles to reconcile the varying demographic data and medical record numbers that different systems assign to the same patient. Sometime (perhaps even years) later, the patient is seen by another healthcare provider at a remote site. The healthcare provider wishes to read the prior x-ray reports. This remote site participates in the same affinity domain and is now regarded as a document consumer. As such, it may query the document registry as to the existence of the prior reports and query the document repository to obtain the reports. Again, patient identity is reconciled and confirmed using the patient identity source and the relevant IHE actors and profiles. This scenario can be expanded to describe the sharing of many kinds of healthcare documents. There are also slight variations permitted in which some of the actors can be placed either within the affinity domain centrally or at one of the sites at which documents arise. Federal Register, Electronic Health Record Incentive Program50 While the Federal Register, Electronic Health Record Incentive Program is not an evidence-based clinical guideline, the HITECH Act requires the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, increasing prevention and improving the continuity of care among health care settings. The Incentive program includes meaningful use objectives and associated measures that pertain to the use of EHRs to facilitate the availability and use of health information. Measure Importance Relationship to desired outcome The current radiology information systems in hospitals generally do not collect or report radiation exposures and the medical imaging devices that communicate with radiology information systems do not currently forward data on the radiation dose received by a patient from each such test. As a result, physicians are uncertain of their patients’ cumulative exposure and lifetime attributable risk (LAR), which is problematic when assessing, prioritizing and discussing the risks and benefits associated with their patients’ clinical needs.51 NQF’s Safe Practices for Better Healthcare-2009 Update: A Consensus Report was prepared incorporating the National Priorities Partnership six crosscutting © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 40 Opportunity for Improvement IOM Domains of Health Care Quality Addressed priorities. Safe Practice 12: Patient Care Information addresses the lack of care continuum by not communicating critical patient information such as medical history, diagnostic test results, medications, treatments, and procedures. The Safe Practice Statement addressing this topic reads as follows, “Ensure that care information is transmitted and appropriately documented in a timely manner and in a clearly understandable form to patients and to all of the patient’s providers / professionals, within and between care settings, who need that information to provide continued care.”52 It has been estimated that between $3 and $10 billion are wasted in the United States annually on unnecessary or duplicative imaging studies. Duplicative imaging procedures could be substantially reduced with improved access to existing imaging data. Additionally, universal access to existing imaging studies to retrieve relevant prior images could improve diagnostic specificity for radiologists and potentially further minimize recommendations for follow-up studies.53 • • • Safe Effective Patient-centered • • • Timely Efficient Equitable Exception Justification The focus and intent of this measure set is to optimize patient exposure to ionizing radiation used in diagnostic studies. Harmonization with Existing Measures Harmonization with existing measures was not applicable to this measure. Measure Designation Measure purpose Type of measure Level of Measurement Care setting Data source • • • • • • • • • • • • • • Accountability Quality improvement Maintenance of Certification® programs Structure Facility Integrated delivery system Multi-site/corporate chain Inpatient care Emergency department Ambulatory care Electronic Administrative Data/Claims Electronic Clinical Data (eg, RIS) (Feasibility of data source TBD) Electronic Health/Medical Record (Feasibility of data source TBD) Registry Data Practice Quality Improvement Module © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 41 Quality Improvement Measures/Additional Measures Included (Measures Not Developed by ABMS/ABR/ACR/PCPI Under This Project) © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 42 Measure #12 Exposure Time Reported for Procedures Using Fluoroscopy (PCPI/ACR/NCQA) Radiology NQF-endorsed® The Patient Radiation Dose Optimization Work Group recommended that this measure, developed by the PCPI, the ACR, and the National Committee for Quality Assurance (NCQA), be referenced in this document as a quality improvement measure that addresses an additional opportunity to optimize patient radiation dosing through appropriate imaging and that may potentially be implemented by radiologists in a Maintenance of Certification (MOC) Part IV project. A full description and technical specifications for this measure can be found within the PCPI/ACR/NCQA Radiology measure set available at: http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit=PCPI. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 43 Measure #13 Pulmonary CT Imaging for Patients at Low Risk for Pulmonary Embolism (Partners HealthCare/Brigham & Women’s Hospital) NQF-endorsed® Measure #14 Appropriate Head CT Imaging in Adults with Mild Traumatic Brain Injury (Partners HealthCare/Brigham & Women’s Hospital) NQF-endorsed® The Patient Radiation Dose Optimization Work Group recommended that these two measures, developed by Partners HealthCare/Brigham & Women’s Hospital, be referenced in this document as quality improvement measures that address additional opportunities to optimize patient radiation dosing through appropriate imaging and that may potentially be implemented by radiologists in a Maintenance of Certification (MOC) Part IV project. The National Quality Forum (NQF) Board of Directors announced the endorsement of these two measures in April 2011. Full descriptions and specifications for these Partners HealthCare/Brigham & Women’s Hospital measures are available at: http://www.brighamandwomens.org/Research/labs/cebi/bestcare/HowDoWeAvoid.aspx# quality © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 44 Guideline Evidence Classification and Rating Schemes Optimizing Patient Exposure to Ionizing Radiation American College of Radiology (ACR) APPROPRIATENESS CRITERIA® Evidence Table Development Evidence Table Development A. Purpose: To determine the quality of each reference and present the evidence in a succinct format. Typically, the quality is referred to as the strength of evidence (SOE) rating for the study. The SOE rating is called Study Quality in the evidence tables (ET) of the more recent AC. B. General Information: The research associate (RA) develops an ET for each AC topic. The ET consists of the citation, study type, number of patients, study objective, study results and SOE (or study quality) for all articles included in the narrative reference list. C. Defining the Elements of the Evidence Table 1. Citation – Author(s), title, journal, volume and date should be included. 2. Study Type –Studies are classified based on the study types as shown in appendix A. The first nine study types are used for studies on treatments while the remaining eight are used for studies on diagnostic interventions. 3. Patients/Events – The number of patients included in the study and/or the number of images evaluated is listed in this column. The number of observers or interpreters of images, if mentioned in abstract, should also be included. If patients in the study are placed in different groups, the number within each group should be listed separately. If the study is a quantitative review, the number of studies included in that review should be listed. The column should be filled with N/A to indicate “not available” if the number of patients is unavailable or if the document is not concerned with individual patients (as in the case of guidelines). 4. Study Objective – The central question(s) addressed by the study is listed in this column. Some indication of how the study was structured may be included. For example, “A retrospective review of patient records was undertaken to determine whether those who had an MRI had a lower rate of surgery than patients who had ultrasound”. 5. Study Results – The principal findings of the research should document the overall conclusions of the study authors (e.g., CT should not be performed for this patient group). Additionally, specific numerical results should be included when practical. 6. Strength of Evidence (SOE) or Study Quality – A four category rating scale is used to describe the evidence. “Category 1” denotes the strongest level of evidence and “Category 4” the weakest. For each study, a rating from the scale below is assigned, with the exception of “book chapters” which are assigned N/A. CODE 1 CATEGORY NAME Category 1 2 Category 2 3 Category 3 4 Category 4 CATEGORY DEFINITION The conclusions of the study are valid and strongly supported by study design, analysis and results. The conclusions of the study are likely valid, but study design does not permit certainty. The conclusions of the study may be valid but the evidence supporting the conclusions is inconclusive or equivocal. The conclusions of the study may not be valid because the evidence may not be reliable given the study design or analysis. ACR Appropriateness Criteria® - Procedure Contrast Information Contrast agents are widely referred to in the ACR Appropriateness Criteria®. References to them follow sound general principles. Currently, all MRI and MRA procedures that refer to contrast specifically mean gadolinium-based compounds. Other agents are now available, but data on their comparative effectiveness are still relatively sparse. Oral or rectal contrast is a barium preparation unless otherwise specified. Intravenous contrast for all imaging procedures involving ionizing radiation © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 45 is iodine-based. There are many different specific iodine–and gadolinium–based agents that are currently available. At this time, however, despite extensive debates in the published literature and some conflicting results, there are no situations in which studies are sufficiently definitive to mandate the use of one specific agent as compared to others. There are four basic terms used throughout the Appropriateness Criteria describing the use of intravenous contrast for a specific procedure in a given clinical scenario: 1. “without contrast” (A contrast agent is not recommended.) 2. “with contrast” (A contrast agent is recommended.) 3. “without and with contrast” (It is recommended that the procedure first be performed without a contrast agent followed by a procedure with a contrast agent.) 4. “with or without contrast” (Available studies suggest that the procedure is equally definitive with or without the use of a contrast agent.) The issue of nephrogenic systemic fibrosis (NSF) in relation to gadolinium-based contrast agents is addressed in the Appropriateness Criteria topics in which it is relevant. There are clear concerns about specific agents and specific settings in regard to NSF. Other issues concerning contrast agents, including prevention, diagnosis and treatment of reactions, contrast-induced nephropathy (CIN), and NSF are addressed in detail in the ACR Manual on Contrast Media. ACR -- Process to Developing Practice Guidelines and Technical Standards As part of the overall reorganization of the ACR Commission and Committee structure, the Standards and Accreditation Commission (renamed the Quality and Safety Commission) was formed. It is one of eight operational commissions. The members of this commission are, to a large extent, composed of people who also serve on a specialty commission. There are eleven specialty commissions and each of these commissions has a series of operational committees, one of which is a Guidelines and Standards Committee. The chairpersons of these committees make up the membership of the Quality and Safety Commission. This guarantees a broad spectrum of specialty representation on the Commission as well as members from private practice settings and academic medical centers with a wide geographic distribution. The method for developing a practice guideline or technical standard starts with the specialty commissions or committees receiving suggestions for guidelines or standards from organizations, individual practicing radiologists, ACR State Chapters, or any other appropriate entity related to the specialty of radiology. A proposal form is submitted to the chair and vice-chair of the commission for approval. Once approved, a draft is developed and then circulated throughout the guidelines committee for review and comment until deemed ready to submit for full member comment. If done collaboratively, a committee is formed with members of each collaborating society. The guideline is developed and then sent to the collaborative societies for review and comment. The draft guideline or standard is available on the ACR Web site for on-line commenting during a three-week field review cycle. The ACR Web site provides access to the draft documents for all members to submit their comments online. After each field review cycle, a Chair is appointed by the Council Steering Committee (CSC) and a subcommittee is formed. A conference call may be scheduled for a guideline/standard if comments were received during the field review. The subcommittee members include the principal drafters (drafting committee), Chairs of sponsoring Commission and Committee, Speaker, Vice-Speaker, 2-3 field review commenters, 2-3 guidelines committee members, collaborative committee members, ACR staff and legal counsel. The revised draft from this conference call is then placed on the ACR Web site for an additional 3-week review period prior to the ACR Annual Meeting and Chapters Leadership Conference (AMCLC). If collaborative, the revised draft is sent to the collaborative society for approval. Comments are collated and provided to an assigned ACR Reference Committee to be considered as testimony at the AMCLC. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 46 The approval process for collaborative guidelines during the AMCLC was revised in 2008. All guidelines, whether ACR only or collaborative, are treated in the same manner, allowing for testimony from the floor to be considered and draft language to be amended by the Reference Committee. The ACR also established a process to allow representatives at the AMCLC in order to provide input from the collaborating societies’ on amendments to the collaborative guidelines proposed by ACR councilors. The guidelines or standards that are approved at the AMCLC are published in a CD format and mailed to all College Members for implementation in their practices. The effective date for guidelines or standards is October first of that year. This process provides opportunity for input from all sectors of radiology. The chairperson of the Quality and Safety Commission is most interested in this broad participation and invites comments as well as proposals for new practice guidelines or technical standards from all members of the American College of Radiology. The National Council on Radiation Protection and Measurements (NCRP) NCRP is a nonprofit corporation chartered by Congress in 1964 to: 1. Collect, analyze, develop and disseminate in the public interest information and recommendations about (a) protection against radiation and (b) radiation measurements, quantities and units, particularly those concerned with radiation protection. 2. Provide a means by which organizations concerned with the scientific and related aspects of radiation protection and of radiation quantities, units and measurements may cooperate for effective utilization of their combined resources, and to stimulate the work of such organizations. 3. Develop basic concepts about radiation quantities, units and measurements, about the application of these concepts, and about radiation protection. 4. Cooperate with the International Commission on Radiological Protection, the International Commission on Radiation Units and Measurements, and other national and international organizations, governmental and private, concerned with radiation quantities, units and measurements and with radiation protection. The Council is the successor to the unincorporated association of scientists known as the National Committee on Radiation Protection and Measurements and was formed to carry on the work begun by the Committee in 1929. The participants in the Council’s work are the Council members and members of scientific and administrative committees. Council members are selected solely on the basis of their scientific expertise and serve as individuals, not as representatives of any particular organization. The scientific committees, composed of experts having detailed knowledge and competence in the particular area of the committee's interest, draft proposed recommendations. These are then submitted to the full membership of the Council for careful review and approval before being published. © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 47 Summary of Non-Material Interest Disclosures None of the members of the Patient Optimizing Patient Exposure to Ionizing Radiation Work Group had any disqualifying material interests under the PCPI Conflict of Interest Policy. The following is a summary of non-disqualifying interests disclosed on Work Group members' Material Interest Disclosure Statements (not including information concerning family member interests). Completed Material Interest Disclosure Statements are available upon request. Work Group Member Disclosures David Seidenwurm, MD (Co-Chair) Sole Ownership: Medical Legal Expert Witness Salary Support: Radiological Associates of Sacramento Medical Group (RASMG) Royalties/IP Rights: Textbook Chapter; Meals: Occasional; Books: Textbook Chapter; Consulting Services: Medical Legal Expert Witness Fiduciary Relationship: Director, RASMG Inc.; Co-Director, California Management Imaging (CMI) Consulting Services: OSI Pharmaceutical, Brain Tumor Research, Income to Practice Robert D. Rosenberg, MD Financial Relationship: Salary Support: University of New Mexico, FDA; Research or other Grant Support: American Cancer Society Fiduciary Relationship: Officer, Treasurer of New Mexico Society of Radiologists Previous Service on Quality Committee: ACR Howard Sandler, MD, MS Stock Ownership: Biogen, Amgen, Tomotherapy (now sold) Research or Grant Support: American College of Radiology/Radiation Therapy Oncology Group (RTOG); Speaking Appointments: Sanofi-Aventis; Consulting Services: Varian, Calypso, Myriad, Genentech, Ortho, ITA Partners Medical Advisory Board Peer Reviewed Journals: Journal of Clinical Oncology (JCO) © [2014] American Board of Medical Specialties, American College of Radiology and American Medical Association. All Rights Reserved. 48 References 1 Mettler FA, Jr, Bhargavan M, Faulkner K, et al. Radiologic and nuclear medicine studies in the United States and worldwide: frequency, radiation dose, and comparison with other radiation sources—19502007. Radiology. 2009;253:520–531. 2 National Council on Radiation Protection and Measurements. Ionizing radiation exposure of the population of the United States. Report No. 160. Bethesda, MD: National Council on Radiation Protection and Measurement; 2009. 3 Fazel R, Krumholz HM, Wang Y. et al. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009;361(9)849- 857. 4 Medicare Payment Advisory Commission. Report to the Congress: Medicare payment policy Washington, DC: MedPAC, March 2012. 5 Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices, GAO-08-452. Washington, D.C.: June 2008. 6 Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. 7 Amis ES, Butler PF. ACR white paper on radiation dose in medicine: three years later. 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