Points of Interest from the 2004 ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safe

Released in 2004, this important report, the ACCF/AHA/HRS/ SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided Invasive Cardiovascular Procedures, A Report of the American College of Cardiology Foundation/ American Heart Association/American College of Physicians Task Force on Clinical Competence and Training, looked at what cardiologists, who perform invasive and interventional procedures, should consider when they perform procedures that use ionizing radiation and may exceed normal levels of fluoroscopy and cinefluoroscopy. The writing committee consisted of seven cardiologists and two other writers (Balter and Wagner), who are faculty members of the American College of Radiology and also of the American Association of Physicists in Medicine. A task force consisting of seven physicians worked closely with the writing committee to accomplish the task of writing this dissertation. In this excellent document, the authors recommend measures that need to be undertaken via a curriculum that educates the primary responsible person the physician on radiation safety. To derive at this set of guidelines, the physicians and medical physicists discuss the physics of x-radiation; measurement of radiation dosage; harmful effects of x-ray exposure to patients, which is the most important; risks from invasive cardiovascular procedures; responsibilities of the physician to the patient; and recommendations of radiation safety for physicians, including deterministic and stochastic effects that can occur when patients are exposed to ionizing radiation. The authors also discuss the need to make considerable movement towards the goal of requiring all physicians to complete such a curriculum, which may indicate that many facilities need to improve and enhance radiation safety measures. The statement contains a reference to JCAHO™s publishing of proposed credentialing standards that relate to use of fluoroscopy. JCAHO suggests formal classroom training that includes radiation physics, image physics, and technology, patient and staff radiation management, operational training on individual fluoroscopic units and the need for continuance of medical education on the subject.2 The statement parallels the suggested curriculum of JCAHO and indicates that two levels of education basic and advanced be provided. The authors developed an excellent radiation safety curriculum for physicians who perform cardiovascular procedures. The advanced portion focuses on more detailed subjects such as x-ray dosimetry, image acquisition, image processing, radiation effects, patient dose and staff safety. The basic course focuses on operational and safety factors. The authors stress that physicians must possess a basic knowledge of radiation physics, radiation safety and radiation protection. Each cardiovascular lab should develop policies and procedures that focus on the proper use of fluoroscopy. Also, they note that a medical office credentialing process should be developed so physicians are authorized to operate ionizing radiation-producing equipment. This process should require the necessary thresholds of knowledge pertaining to fluoroscopic-guided procedures, which also assures the highest level of patient and staff safety. Without any reproach, the authors present a document that is clearly directed at the increase in reported cases of radiation injuries, some of which are presented in the photographs on page 2,261 of the statement. The authors™ major concern is the length of complex procedures such as percutaneous coronary interventions (PCI) and electrophysiology studies (EPS), which may have over 20 minutes of fluoroscopy and cine fluoroscopy. (We have been involved in procedures where the fluoroscopy times have exceeded 60 minutes.) Hirshfeld et al. has prepared an excellent section on the effects of ionizing radiation to patients. His group clarifies the need to employ risk-benefit processes to reduce deterministic effects (skin injury, hair loss) and stochastic effects that can cause neoplastic growths and genetic alterations. Furthermore, the article provides an excellent definition of deterministic effects pertaining to predictable dose-related events. The stochastic effect remains perpetually problematic because its severity has no relationship to the patient-received dose, especially if a woman who is child-bearing age has exposure to her pelvic area, whether she is or is not pregnant. If a fetus is exposed to radiation, genetic effects can occur and a high risk of cancer exists for a lifetime. Most importantly, the authors sound a clear note that the physician-in-charge is responsible for the patient and the support staff that may consist of cardiology fellows, nurses and technologists. It is the attending physician who is responsible for the performing the procedure safely while attempting to minimize the risk of radiation injuries. Interestingly, the authors suggest mentioning to the patient that he or she may have chance of developing a radiation injury, as well as the need to place a statement of such on the informed consent, which covers the nature of the procedure, why it is being done, possible complications, and other medical issues that could occur. Clarification of the need for procedural dose management was included and pinpointed the three basic principles of ALARA: No known safe dose on ionizing radiation is known. Risks of adverse effects coincide with smaller doses. Ionizing radiation exposures have cumulative effects. The authors list nine other principles that can be used to reduce exposure to patients. The nine fundamental concepts are (1) Minimize beam-on time, both for fluoroscopy and acquisition; (2) Use optimal beam collimation; (3) Position the x-ray source and image receptor optimally; (4) Use the degree of image magnification required for accurate interpretation; (5) Understand and use the x-ray dose-reduction features provided by the x-ray unit; (6) Vary the site of the radiation entrance; (7) Record the estimated dose delivered to the patient; (8) Maintain x-ray equipment in good repair and calibration; and (9) Select x-ray units with sophisticated dose-reduction and monitoring features. The determinants of patient doses are also discussed. Seemingly new terms utilized are the dose of the interventional reference point (IRP) and the dose-area product (DAP). The DAP is the product of the absorbed dose to air and the cross-sectional area of the x-ray beam. The IRP is the dose located at the x-ray beam at 15 cm from the isocenter on the x-ray tube side (PA). This reference is located at the skin where the beam enters the patient when the heart is at isocenter. In closing, these sixteen highly regarded medical professionals have presented an excellent dissertation on the physics of cardiac angiography, radiation physics, radiation biology, radiation safety, imaging equipment, and image formation. We suggest that this article be required reading for all students who are actively studying to be radiographers, as well as advanced-level radiology practitioner assistants, registered and student cardiovascular invasive specialists, and cardiovascular lab-based nurses. The material included in the article covers the important highlights of radiation safety and the risks that can follow if the guidelines are not followed. A daily practical quality improvement program, which was originally developed by the SCA&I in the early 1980s by the founders of the SCA&I (Drs. Melvin Judkins and F. Mason Sones), has not been redeveloped to QA the latest ultramodern digital imaging equipment. The removal of 35 mm cine film systems nullified QA programs, and their reinstatement is a suggested area that the ACCF, AHA, HRS and SCA&I should consider. In conclusion, although this article was published in 2004, it remains the most authoritative document to date that focuses on the need for ongoing continuing education to optimize patient safety and image quality when patients undergo prolonged fluoroscopic guided invasive cardiovascular procedures.¹ The authors express the need for clinical competency with the use of ionizing radiation. We had to complete a lengthy course on radiation biology coupled with radiation safety for the Radiology Practitioner Program, Weber State University, Ogden, Utah. We wrote this article as a suggestive means for occupational workers, who are employed in cardiovascular labs or interventional radiology suites, to read and refresh their knowledge about the need to protect the patients under their direct care and ourselves (the physician and support staffs) from unnecessary ionizing radiation exposure.

References 1. Hirshfeld JW, Balter S, Brinker JA, et al. ACCF/AHA/HRS/SCAI Clinical competence statement on optimizing patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: A report of the American College of the Cardiology/American Heart Association/American College of Physicians Task Force on Physicians Task Force on Clinical Competence (ACCF/ AHA/HRS/SCAI Writing Committee to Develop a Clinical Competence Statement on Fluoroscopy. Am J Coll Cardiol 2004;44:2259–2282. 2. Joint Commission on Accreditation of Healthcare Organizations. JCAHO Comprehensive Accreditation Manual for Hospitals Update 3. Oakbrook Terrace, IL. 2002.