Physician Qualifications in the Clinical Diagnostic Vascular Laboratory
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1 Physician Qualifications in the Clinical Diagnostic Vascular Laboratory 2 M. Ashraf Mansour Abstract The Diagnostic Vascular Laboratory plays a central role in vascular practice. In the evaluation of patients with vascular disease, the fi rst step is a history and physical examination. The next step to investigate vascular disease is often a noninvasive vascular test performed in the Diagnostic Vascular Laboratory. Therefore, it is essential that testing be performed using the highest standards to ensure an accurate diagnosis. To achieve a high degree of accuracy and consistency, the vascular laboratory personnel, including technologists, supervisors, and interpreting physicians, have to be highly quali fi ed. This chapter describes the necessary quali fi cations for physicians providing interpretation in accredited vascular laboratories. Keywords Vascular laboratory Accreditation Qualifications Introduction The clinical vascular laboratory is an integral part of any busy vascular clinical practice. Vascular clinicians have come to rely on the Diagnostic Vascular Laboratory (DVL) as an extension to the physical examination and comprehensive evaluation of the patient with a vascular disorder. The origins of the DVL go back to the middle of the last century when the specialty of vascular surgery was still in its infancy. Vascular surgeons had to rely on diagnostic angiography to plan revascularization [1 ]. Noninvasive tests were initially rudimentary and employed only in research and physiology laboratories [2 ]. It was the pioneering work of Strandness and Sumner at the University of Washington in the 1960s elucidating vascular hemodynamics and the collaborative work with engineers that ultimately led to the development of more sophisticated instruments to detect and measure blood fl ow [ 1 3 ]. Subsequently, the development of ultrasound technology led to noninvasive imaging, now ubiquitous in of fi ces and hospitals around the world. The portability of equipment and the relative ease of running the diagnostic machines have led to the proliferation of testing sites and commercial enterprises that perform vascular testing or screening for pro fi t, and sometimes without regard for quality or accuracy. The purpose of this chapter is to describe the clinical quali fi cations of the physician interpreting noninvasive studies in the DVL. M.A. Mansour, M.D., RVT, FACS Academic Chair of Surgical Specialties Spectrum, Health Medical Group, Michigan State University, Grand Rapids, Michigan, USA Department of Cardiovascular Surgery, Michigan State University, 4100 Lake Drive SE, Suite 300, Grand Rapids, MI , USA ashraf.mansour@spectrumhealth.org A.F. AbuRahma, D.F. Bandyk (eds.), Noninvasive Vascular Diagnosis, DOI / _2, Springer-Verlag London 2013 Vascular Laboratory Accreditation Physicians rely on the vascular laboratory for the diagnosis, management, and long-term follow-up of patients with vascular disorders. Therefore, it is imperative that the quality of the studies performed, and indeed the proper interpretation of these studies, be accurate and reliable. The origin of the 11
2 12 M.A. Mansour Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) is traced back to 1990 when several professional societies recognized the need to standardize vascular testing and implement a process for veri fi cation [4, 5 ]. While other organizations have established different standards for accreditation of vascular labs, for example, the American College of Radiology (ACR), it is clear that ICAVL accreditation is more rigorous and sought after. Testing procedures, standards for interpretation, and quali fi cations of vascular technologists and physician readers and directors are outlined in careful detail on the ICAVL website www. ICAVL.org (ICAVL Standards) [ 4, 5 ]. After initial accreditation, each DVL has to go through a reaccreditation process in 3-year cycles. Random on-site visits by trained evaluators are done, and in some cases mandatory visits can be triggered to ensure that testing procedures and protocols are in fact being followed. The process of accreditation is fairly laborious and anxiety provoking for lab personnel but is viewed by most professionals who participate as fair (see Chap. 1 ). ICAVL is now Intersocietal Accreditation Commission (IAC). Why should we care if the DVL is accredited and the physician doing the interpretation is quali fi ed? Quite simply, if a patient is sent to the vascular lab and receives a false-positive test, this may expose the patient to additional unnecessary testing or procedures with potential complications. On the other hand, a patient receiving a false-negative test may have a false sense of security, delay in diagnosis, and potentially an adverse clinical event. Unfortunately, this happens too frequently in current clinical practice. A typical example is that of a patient with an asymptomatic cervical bruit referred for a carotid duplex scan. A false-positive scan may lead to another more invasive test, such as a CT or cerebral angiogram. It is less likely, but possible, that this patient could be subjected to an unnecessary carotid endarterectomy based on this erroneous initial test. On the other hand, if the test is a false negative, and the patient has a critical stenosis, watchful waiting may lead to cerebrovascular symptoms, even a stroke. With the proliferation of vascular labs and mobile units, many payers have begun to require that testing facilities be accredited. According to the ICAVL website, the Centers for Medicare & Medicaid Services (CMS) requirements in most states stipulate that the lab and/or the technologist performing the test needs to be credentialed in order to receive reimbursement. Clearly, this is an important fi rst step to ensure that vascular testing is done properly. The substandard testing in some unaccredited labs should be considered fraud and abuse and invariably leads to repeat testing in an accredited lab [ 6 ]. In response to the perceived overuse of diagnostic imaging, the US Congress mandated major payment cuts for all diagnostic modalities in the De fi cit Reduction Act of Thus, reimbursement for many tests performed in the DVL was reduced by up to 40% [ 7 ]. Cardiology Vascular medicine Radiology Vascular surgeon Patient Neurology Educational Background Patients with vascular disorders will frequently be touched by multiple specialists from varying backgrounds (Fig. 2.1 ). Postgraduate education in vascular surgery and vascular medicine are two well-de fi ned pathways to achieve board certi fi cation in a vascular specialty. Successful completion of an accredited vascular surgery training program is a requisite to sit for the American Board of Surgery Vascular Certi fi cate. Similarly, training in an accredited Vascular Medicine program will lead to eligibility to sit for the Vascular Medicine Certi fi cate of the American Board of Internal Medicine. The structured curricula in the latter specialties build on the essential elements listed in Table 2.1 [8 10 ]. Other specialties, such as neurology and radiology, receive more focused instruction and training in their respective areas. Interventional radiologists have broad training in invasive procedures, including angiography and other diagnostic modalities. Therefore, physicians from various backgrounds and training (e.g., neurology, radiology, vascular medicine, vascular surgery) may become quali fi ed to interpret carotid duplex scans or transcranial Dopplers based on their training and area of expertise. Physician Qualifications Primary care Podiatry CT surgery Fig. 2.1 Medical and surgical specialties interacting with the vascular patient The ICAVL explicitly states that a DVL is a unit performing noninvasive vascular diagnostic testing under the overall direction of a medical director [ 4 ]. The intent is to place the
3 2 Physician Quali fi cations in the Clinical Diagnostic Vascular Laboratory 13 Table 2.1 Suggested curriculum for physicians interpreting in the vascular laboratory Pathophysiology of vascular disease including arterial (atherosclerotic and nonatherosclerotic), venous, and lymphatic Ultrasound physics, Doppler instruments, transducer technology Basis of physiologic testing (ABI, PPG, APG) Duplex imaging of arteries, veins, vascular conduits, and soft tissue Ultrasound and duplex diagnosis of: Aortic aneurysms and other aortoiliac disease Imaging for aortic stent grafts Renal and mesenteric arteries and veins Renal and liver transplants Portal venous system Carotid arteries and structures in the neck Lower extremity occlusive and aneurismal disease Bypass grafts Venous reflux testing Arteriovenous access for dialysis Statistical methods and understanding of false positive, negative, and accuracy Advantages and limitations of vascular diagnostic modalities Adapted from Refs. [8, 10 ] ABI ankle-brachial index, PPG photoplethysmography, APG air plethysmography overall responsibility for a VDL in the hands of a quali fi ed physician who can then ensure that the lab is complying with accepted standards. The medical director should be (1) legally quali fi ed physician and (2) have achieved one or more of the following: (a) completion of a formal residency or fellowship (e.g., vascular surgery fellowship or residency, vascular medicine, radiology, or cardiology with dedicated vascular laboratory rotation during fellowship) that includes appropriate clinical and didactic vascular laboratory experience with a de fi ned number of studies interpreted (this would be the ideal quali fi cation for both a medical director or interpreting physician), (b)self-study training through formal accredited postgraduate education and supervised vascular laboratory experience (preferably in accredited vascular laboratory under formally trained medical director) with interpretation of a de fi ned number of cases, and (c) previous work in a vascular laboratory (preferably in accredited vascular laboratory under formally trained medical director) with interpretation of a de fi ned number of cases [ 4 ]. The latter criteria also apply to the interpreting physician. The general quali fi cations of physicians interpreting in the DVL and eligible to sit for the RPVI examination are outlined in Table 2.2. Besides the basic requirement of a medical degree and formal training in the fi eld, the following qualifications are essential [10]: License to practice medicine in the state Board certification Thorough understanding of instrumentation, limitations of tests Table 2.2 Troubleshooting Knowledge of vascular disorders Knowledge of statistics (false positive, accuracy) Continuing Medical Education (CME) Knowledge of techs ability and limitations Objectivity (no bias or conflict of interest) Much of the experience gained in formal training programs by attending regular clinics, conferences, and quality assurance meetings in the vascular lab leads to thorough understanding of the tests, their utility, and limitations. Discussions with vascular technologists and other physicians lead to a better understanding of a missed diagnosis, challenges with special anatomic variants, or speci fi c patient conditions. Some diagnostic studies are typically more challenging, such as renal or mesenteric duplex, and it is always helpful to get the most experienced techs and readers to share their knowledge and expertise with colleagues. There is emphasis on a minimum number of tests reviewed to highlight the value of a broad experience. It is unfortunate that in recent times, there has been a proliferation of weekend courses claiming to deliver suf fi cient information so that a minimally trained physician can become a certi fi ed reader after 20 hours of instruction. Credentialing Common pathways leading to RPVI Doctorate in Medicine Valid license to practice medicine (MD or DO) Previous RVT certification (ARDMS) Satisfactory completion of ACGME-approved postgraduate training program Documentation of supervised interpretation of 500 vascular studies in the following areas: Carotid duplex Transcranial Doppler Peripheral arterial physiologic testing Venous duplex ultrasound Visceral duplex ultrasound Satisfactory completion of CME in noninvasive diagnosis From: Physicians Vascular Interpretation (PVI) Examination General App Book In the early days of the vascular lab, technologists came from various backgrounds of nursing or other allied health professions. Recently, ICAVL has instituted more rigorous education and training requirements for vascular technologists. The American Registry for Diagnostic Medical Sonography (ARDMS) administers the Registered Vascular Technologist (RVT) test which has two components, ultrasound physics and vascular technology. Individuals enrolled in approved programs in fact can sit for the RVT exam after completing
4 14 M.A. Mansour Table 2.3 Major content areas on RPVI examination 1. Instrumentation and ultrasound physics 2. Extracranial cerebrovascular 3. Intracranial cerebrovascular 4. Peripheral venous 5. Peripheral arterial 6. Visceral vascular 7. Special testing 8. Quality assurance and ultrasound safety From: Physicians Vascular Interpretation (PVI) Examination their course work. This would enable the graduate to seek employment in an accredited vascular lab immediately upon graduation. The ICAVL has very speci fi c requirements for supervision and oversight in the vascular lab, both by a lead technologist and physician director. This oversight is important to ensure quality studies, procedures, and reporting. The physician in the DVL needs to be knowledgeable and competent in three main areas: performance of tests, interpretation and reporting, and quality assurance. While the physician does not necessarily have to perform the test, it is important to have a physical presence for supervision and guidance of the technologists [ 11 ]. The preliminary and final reports issued by the DVL need to conform to standards and provide accurate and useful information to referring physicians. Finally, maintaining quality and excellence in the DVL, through constant review, training, and completion of CME by attending conferences and courses, keeps the lab personnel and physicians up to date and knowledgeable in this area. The vascular surgical and medical societies have developed guidelines for hospital privileging [ 12 ]. Furthermore, thought leaders from multiple disciplines have published a consensus statement outlining speci fi c recommendations for physicians in the DVL. These recommendations encompass core knowledge, cognitive skills, and training requirements [8, 9 ]. Clearly, a consensus has emerged that physicians who are in a position to interpret noninvasive vascular studies need to demonstrate that they have mastered certain competencies. The RPVI test, which was developed in 2006, was designed to test such knowledge and competency [ 5 ] (Table 2.3 ). Recently, the American Board of Surgery declared that vascular surgeons seeking certi fi cation after fellowship and recerti fi cation in vascular surgery after 2014 will need to have the RPVI. It should be noted, however, that having passed the RPVI exam without the proper training as described previously should be discouraged. Although most DVLs were started and directed by vascular surgeons, the last two decades have seen a gradual shift to other specialties, particularly cardiology, running labs. Data from ICAVL show that in 1993, 76% of DVL directors were vascular surgeons compared to 51% in 2011 (see Fig. 2.2 ). Percentage vascular surgeon radiologist internal medicine While the proportion of DVL directed by radiologists has declined since ICAVL started keeping track, the last decade has seen a signi fi cant rise in the number of labs directed by cardiologists. The specialty of physician directors in the DVL is probably irrelevant, as long as good leadership and maintenance of high standards are enforced. References cardiologist neurologist shared/other Fig. 2.2 Medical specialty of the medical director in accredited vascular laboratories (Courtesy of S. Katanick, ICAVL Executive Director, 2011) 1. Strandness DE. Historical aspects. In: Strandness DE, editor. Duplex scanning in vascular disorders. New York: Raven Press; p Winsor T. Simplified determination of arterial insufficiency: plethysmographic observation of reactive hyperemia following fi fteen minute arterial occlusion at the ankle. Circulation. 1951;3: Strandness DE, Sumner DS. Measurement of blood fl ow. In: Strandness DE, Sumner DS, editors. Hemodynamics for surgeons. New York, San Francisco, London: Grune & Stratton; p Akbari CM, Stone L. Accreditation and credentialing in the vascular laboratory. Semin Vasc Surg. 2002;15: Zierler RE. Credentialing and accreditation. In: Zierler RE, editor. Duplex scanning in vascular disorders. 4th ed. Philadelphia: Wolters Kluwer; p Brown OW, Bendick PJ, Bove PG, Long GW, Cornelius P, Zelenock GB, Shanley CJ. Reliability of extracranial carotid artery duplex ultrasound: value of vascular laboratory accreditation. J Vasc Surg. 2004;39: Mansour MA, Zwolak RM. Of fi ce-based vascular lab: is it worth the effort? Perspect Vasc Surg Endovasc Ther. 2009;21:5 8.
5 2 Physician Quali fi cations in the Clinical Diagnostic Vascular Laboratory Creager MA, Goldstone J, Hirshfeld JH, Kazmers A, Kent KC, et al. ACC/ACP/SCAI/SVMB/SVS clinical competence statement on vascular medicine and catheter-based peripheral vascular interventions. JACC. 2004;44: Creager MA, Cooke JP, Olin JW, White CJ. Task force 11: training in vascular medicine and peripheral vascular catheter-based interventions. JACC. 2008;51: Ricci MA, Rutherford RB. Qualifications of the physician in the vascular diagnostic laboratory. In: Abu Rahma AF, Bergan JJ, editors. Noninvasive diagnosis. London: Springer; p Rutherford RB. Qualification of the physician in charge of the vascular diagnostic laboratory. J Vasc Surg. 1988;8: Calligaro KD, Toursarkissian B, Clagett GP, Towne J, Hodgson K, Moneta G, et al. Guidelines for hospital privileges in vascular and endovascular surgery: recommendations of the Society for Vascular Surgery. J Vasc Surg. 2008;47:1 5.
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