Good morning. I am Anne Jones, and I am a vascular technologist certified in two ultrasound specialties. I have been involved in the medical profession as an RN for more than twenty years, working in the areas of cardiology, pediatrics vascular surgery, and neurology. I became a member of the Society of Vascular Technology or SVT in 1979 and have served as Chairman of various committees as well as past president. In light of my active participation with SVT, I am delighted to represent this organization at today's public meeting to discuss the effects of credentialing of technologists and sonographers on the quality of ultrasound tests. As the lead agency charged with supporting research designed to improve the quality of health care, we very much appreciate AHRQ's attention to and interest in this important matter. Because we share AHRQ's commitment to quality health care, we would be very pleased to assist AHRQ in any way that we possibly can.

SVT is a multidisciplinary professional society with more than 4,000 members, including physicians, nurses, technologists and other allied health members, all dedicated to the provision of quality diagnostic testing services. SVT would like to make it clear that our participation in today's public meeting is simply to share our perspective about credentialing and ultrasound. SVT has no financial stake in the credentialing process and is interested in this project and its outcome purely from a patient care perspective.

We are pleased that Congress has recognized the importance of credentialing in the delivery of health care services, through the establishment of this study in the Balanced Budget Refinement Act. The statute states, "the Administrator for Health Care Policy and Research shall provide for a study that. . . compares differences in quality between ultrasound furnished by individuals who are credentialed by private entities or organizations and ultrasound furnished by those who are not so credentialed." This wording plainly states Congress' clear intent for this study to focus on the issue of credentialing, as opposed to any other possible quality assurance mechanism. Although some may wish to consider other factors that might have bearing on the provision of quality services, the plain language of the statute forecloses that. However, because we are very much supportive of laboratory accreditation as well, we would be happy to work with AHRQ and accrediting bodies in seeking Congressional approval for a separate study, if accrediting organizations are interested in pursuing this.
Like many others in the health care industry, SVT is concerned by the findings included in the Institute of Medicine's report, "To Err is Human". In reviewing the report, I was struck by a number of points, which appear to confirm SVT's belief that credentialing is essential to the delivery of quality health care services.

For instance, the report states that "More than two-thirds of the adverse events found in th[e] study were thought to be preventable, with the most common types of preventable errors being technical errors (44 percent)...", with a particular focus in errors in vascular and cardiac surgery services, two areas where ultrasound is a critical diagnostic tool. In addition, the report specifically recognized the need for "a skilled and knowledgeable workforce" and recommended that health care organizations work with credentialing groups to reduce the disturbing incidence of medical errors.

Many, but not all, Medicare carriers have established minimum levels of competency as a requirement for reimbursement. We believe that these determinations reflect a clear endorsement of the value of credentialing in ensuring medically appropriate services. As you know, federal government health programs serve as a model for the private sector, and we are hopeful that this study will establish what we believe to be the clear need for government's leadership in protecting patients from the errors of unqualified practitioners.

Ultrasound services play an extremely important role in health care. From an appropriate ultrasound study, a physician can detect problems and abnormalities, which serve as the basis for the next step in patient care, such as the dispensation of proper medication or the need for surgery. Inappropriate and poor quality ultrasound services, similarly, can lead to unnecessary, incorrect, counter-productive, and risky treatments, or omitted treatment that should be required. Frank West, former president of SVT, participated in a Prime TIME Live segment, which tested the services provided in ultrasound laboratories using many uncredentialed practitioners.

The segment focused on a gentleman with known subclavan artery blockage. He obtained services from uncredentialed personnel, and he received incorrect diagnoses in almost every case, based on the studies they performed. None of the physicians reviewing the poor ultrasound studies supplied were able to detect the blockage and the patient was informed erroneously by some that the opposite side artery was affected. Mr. West concluded that these services constituted "an indictment of [our] profession", and I agree.
Through the AHRQ study, we hope to see that positive changes result to ensure that patients receive quality ultrasound and are spared from costly mistakes, poor care, or inappropriate care. With that said, however, we know and believe that the purpose of the study must be to provide a fair test of the performance of ultrasound by credentialed and uncredentialed personnel. In keeping with this objective, SVT has a number of suggestions regarding the structure and design of this study. We hope that these suggestions will be of some assistance to you.

First, we recommend that the study focus on cardiac, gynecologic and vascular ultrasound practice. A small number of patients, who have similar known pathologies, should be repeatedly tested by different credentialed and uncredentialed persons. We believe that these areas present the best clinical situations that will offer the fairest test of ultrasound performance by credentialed and uncredentialed personnel and the clearest clinical and economic consequences with poor or erroneous testing. We suggest that services that are not sufficiently challenging will not provide a reasonable test of the skill of credentialed and uncredentialed persons. Further, we suggest that the study focus on entry level sonographers with between one to three years of experience. We believe this is consistent with the idea that most credentialing mechanisms are used to assess the entry level, minimum competency of ultrasound personnel.

We also believe that it is important that AHRQ meet the twenty-four month statutory deadline set by Congress. Based on our advisory panel's effort, which involved the thoughtful analysis of physicians, vascular technologists, sonographers and respected researchers, we believe that this can be done in an appropriate manner that ensures a fair study.

We believe that a useful means of evaluating credentialed and uncredentialed persons would be to require them perform a routine exam and to produce preliminary reports stating their observations about the case. These preliminary reports and the images obtained should be reviewed by a panel of qualified and respected experts in the ultrasound field. This expert panel should not be made aware of the ultrasound personnel's credentialing status to ensure a fair review process.
To further isolate the effects of credentialing, we would encourage the participation of uncredentialed personnel who do not practice with credentialed colleagues, and who are not credentialed in any area of ultrasound. A different approach would not, in our view, sufficiently isolate the effect of credentialing as there would be some spill-over effect of credentialing onto uncredentialed persons otherwise. In addition, we suggest that the participating personnel be unaware of their involvement in a study, so as to reduce the potential for bias and alterations in practice. We also suggest that the study focus on the Southeast and Southwest regions of our country, which have a lower rate of registered sonographers and technologists, as well as a lower rate of Medicare reimbursement requirements. We believe that a geographical focus will increase the ease of securing multiple studies for a limited number of patients with known pathologies. We anticipate that this would help to control costs and ensure timely completion of the study.

Considering the vast impact that ultrasound often has on patient care, SVT has long been concerned that anyone - without any training - can pick up an ultrasound probe and start providing ultrasound services to Medicare and other patients. Because there is no state licensure in any jurisdiction in this country, this can and does happen every day. Credentialing is designed to fill that void and we welcome a fair and impartial test of its effectiveness and value.

Again, SVT is grateful for AHRQ's dedication and commitment to improving quality in the delivery of health care services, and we look forward to working with your agency in any way that we can. Thank you.