The Vascular Lab
What technology and equipment will you need to create an office-based lab?
As therapies for peripheral vascular disease evolve from medical and surgical to endovascular techniques, appropriate methods of diagnosis and follow-up must be available. Most vascular surgeons, vascular internists, and interventional radiologists have experience in vascular diagnostic testing. However, cardiologists are entering the field of endovascular intervention at a rapid pace, and they generally have little experience in vascular testing. According to the Intersocietal Commission for the Accreditation of Vascular Laboratories, approximately 30% of all labs are outpatient based, and 16% of lab medical directors are cardiologists. The majority of medical directors are surgeons and radiologists.
Physical space is the first issue to consider. You may choose to add a significant amount of space for the lab, depending on your anticipated volume and services offered. In general, however, you will need approximately 150 square feet of space for an ultrasound room, and slightly more space for physiologic limb pressure testing with a treadmill. You can include a technologist workspace in each testing room, or provide a separate workroom. Depending on the number of physicians and the proximity of physicians’ offices to the lab, you may also want to create a separate ‘reading room’ where the medical staff will have the space to interpret vascular lab tests.
THE SERVICES YOU PROVIDE
A full-service vascular lab offers general testing modalities including physiologic limb arterial circulation studies with treadmill exercise challenge and duplex ultrasonography.
All vascular laboratories must have handheld Doppler units. These devices are portable and may be used in examination rooms as well as in hospital inpatient rooms. There are several vendors from which to choose including Parks Medical Electronics, Inc. (Shaw Aloha, OR); Nicolet Vascular (Madison, WI); Ultrasound Technologies, Ltd (Caldicot, South Wales, UK); Androline, Inc. (Milan, Italy); and Huntleigh Healthcare, Inc. (Eatontown, NJ).
Recently, handheld Doppler units with built-in waveform recording and printing devices have been made available. This type of technology allows potential reimbursement for the ankle-brachial index. For further information, visit the Nicolet Vascular Web site.
There are several manufacturers of physiologic limb arterial circulation equipment. These devices consist of bidirectional Doppler probes, multiple limb pressure cuffs, and a recording device. The cost increases as the reporting features and automation increase. Some vendors include Parks Medical Electronics, Inc., BioMedix, Inc. (St. Paul, MN), and Nicolet Vascular.
There are other noninvasive modalities to assess cutaneous limb blood flow, including laser Doppler flowmetry and transcutaneous oximetry. Some centers have found these to be particularly useful in assessing wound healing potential. For more information, visit the Vasamedics or Periflux Web sites.
Vascular ultrasonography is the cornerstone of vascular lab testing. Standard duplex ultrasound scanners offer real-time, gray scale, B-mode imaging along with focused Doppler velocity and waveform interrogation. Color imaging can also identify areas of turbulence and stenosis. Ultrasound vendors include Acuson Solutions (Siemens, Malvern, PA), Philips Medical Systems (The Netherlands), GE Medical Systems (Waukesha, WI), Toshiba (Tustin, CA), and Biosound Esaote (Indianapolis, IN).
It is best to evaluate each of these systems independently. Once you have limited your selection to two or three systems, view them in side-by-side demonstrations. You must decide which factors are most important for your laboratory. If you do not plan to perform deep abdominal imaging (ie, renal artery duplex ultrasonography or imaging for abdominal aortic stent-grafts), low-frequency imaging is less important to you than is high-frequency, near-field imaging such as that used in carotid duplex ultrasonography.
REPORTING AND ARCHIVING
Finally, you must consider methods of reporting and archiving your images and reports. There are several commercially available vascular lab reporting products on the market. Many of them not only allow for computerized reporting, but also act as a database in preparation for laboratory accreditation. Some of these vendors include Consensus Medical Systems, Datastar Systems, Inc. (Plano, TX), and In Record Time, Inc. (New York, NY).
Standard dictation is an effective method of prompt reporting if you are planning a single-office lab. The value of dictation is limited, however, by the inability to collect data in preparation for the accreditation process.
Image archiving is becoming a major issue for hospitals and multilocation outpatient centers. Picture Archiving and Communications Systems (PACS) utilizing Digital Imaging in Communications and Medicine (DICOM) format represents the industry standard. Begin your research by visiting the PACS industry vendor information page at http://www.dejarnette.com/efinegan/pacsvend.htm. This frequently updated list of PACS and DICOM vendors provides you with an overview of the available systems.
THE IMPORTANCE OF ACCREDITATION
The ability to demonstrate quality vascular testing is by far the most important aspect of the vascular laboratory. Despite high-quality equipment, state-of-the-art reporting and image management systems, and potentially high patient volume, your staff needs to demonstrate a minimum level of quality and expertise at the outset.
Two vascular laboratory accreditation organizations exist, the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL), and the American College of Radiology Accreditation. The accreditation process is a time-consuming one, and requires dedication to perform and interpret studies in an organized fashion according to well-established testing protocols. Your data collection must be meticulous, and the quality of your work must be demonstrated by comparing the results of vascular laboratory studies with ?gold standard? contrast or magnetic resonance arteriography, or findings at the time of surgery. Given the magnitude of this endeavor, it is best to assign one member of your lab staff to complete the process.
THE SUCCESSFUL VASCULAR LAB
Office-based vascular diagnostic laboratories are critical for practices dedicated to the management of patients with vascular disease. The vascular lab allows for accurate diagnosis, as well as organized surveillance follow-up after intervention. To be successful, a significant amount of planning and organization must occur. Deciding on the amount of space, the types of services to be offered, the preferred methods of testing, and the chosen reporting and archiving systems are all critical to the success of your lab.
Michael R. Jaff, DO, RVT, FACC is Director of the Vascular Diagnostic Laboratory at Lenox Hill Hospital in New York City and is a board member of the Intersocietal Commission for the Accreditation of Vascular Laboratories. Dr. Jaff has no relationship with any manufacturer or vendor mentioned here, he has not received financial compensation for mentioning any product here, and he has no responsibility for the accuracy or reliability of any product or manufacturer listed here. Dr. Jaff may be reached at (212) 702-7400; email@example.com.