Abstract
Introduction
A high-quality vascular laboratory is an essential part of vascular medicine practice. To achieve long-term success and financial sustainability, vascular labs must also be efficient and cost-effective. This Blue Page document aims to provide a general guide on how to build and optimize vascular lab services and operations, leveraging the expertise of the Society for Vascular Medicine’s Vascular Medicine Practice Task Force.
Overview of vascular lab practice
The expanding landscape of vascular disease prevalence and interventions fuels the increasing need for vascular diagnostic laboratories. The primary tool of the vascular lab is duplex (B-mode and Doppler) ultrasound (US), which provides visual assessment of vascular structures and characterization of blood flow velocity and direction. In addition, vascular labs utilize physiologic testing modalities; that is, plethysmography (e.g., pulse volume recordings), continuous wave Doppler, and sphygmomanometry (e.g., ankle–brachial index and segmental pressures) in the diagnosis and surveillance of arterial occlusive disease. 1 Given the versatility, portability, and reproducibility of these modalities, most hospitals maintain an active vascular lab for inpatient and outpatient needs. Vascular specialists in private practice often establish office-based labs as well to complement their outpatient clinical services.
A comprehensive vascular lab testing portfolio is shown in Table 1, as defined by the Center for Medicare and Medicaid Services (CMS). 2 Services offered by each vascular lab may be influenced by the needs and characteristics of the patient catchment area. For example, labs attached to outpatient-based labs and ambulatory surgical centers may develop a protocol for portable intraprocedural imaging to assist interventions such as venous ablation and endovascular arterial revisualization (e.g., retrograde pedal access and crossing of chronic total occlusions). 3 Vascular labs affiliated with stroke/neurology centers may have a niche in performing transcranial Doppler and carotid artery duplex studies. 4
List of studies offered in the vascular diagnostic laboratory. 2
ABI, ankle–brachial index; DVT, deep vein thrombosis; PAD, peripheral artery disease; PVR, pulse volume recording.
Space and equipment
The vascular lab should ideally choose a ground-level facility with easy parking and wheelchair accessibility as many patients with vascular conditions have limited mobility and may be unable to ambulate. Testing rooms should have enough space for a gurney, an US machine, a vascular physiologic diagnostic machine, a treadmill, and workspace for technologists. If venous testing volume is high, vascular labs may wish to purchase an automated rapid cuff inflation/deflation device to perform augmentation maneuvers for venous reflux studies. Further ancillary equipment may be desirable, including a treadmill for exercise challenge, a warming box or access to cooling strategies for thermal provocation studies, and gel warmers. Testing equipment (US machines and probes) should be high quality, reliable, and portable. Given budget constraints, labs may wish to explore the options of purchasing refurbished machines or participating in a leasing program. Affiliated echocardiography laboratories often use the same US machines as vascular labs, and loan agreements may be made between the labs. Software is available from vendors, such as Siemens (syngo Dynamics) and ProSolv CardioVascular, for interpretation templates and study finalization. These programs facilitate standardized verbiage for reporting. Ergonomic seating and postural considerations are important regarding technician comfort and positioning.
Personnel and certifications
The vascular lab is usually led by a medical director, who is a licensed physician with formal training and experience in interpretation of vascular diagnostic studies. Typically, the medical director maintains a Registered Physician in Vascular Interpretation (RPVI) certification. 5 The medical director is responsible for overseeing the entire operation of the lab, with appropriate delegation of specific duties to staff. Other physicians who wish to become ‘readers’ at the lab should have similar qualifications as the director and adhere to uniform interpretation criteria. The vascular lab should also employ a technical director, who is usually an experienced vascular technologist dedicated to helping the laboratory maintain a high quality of patient care and testing. The technical director is considered the lynchpin of lab operations and oversees the extensive list of duties and responsibilities, including applying for and maintaining accreditation (see next section). In addition to the technical director, it is critical for the vascular lab to hire skilled and dedicated technologists who have completed vascular US training and achieved specialty certifications such as Registered Vascular Technologist (RVT) or Registered Vascular Specialist (RVS). 5 Given the diversity of vascular beds and surrounding complex anatomical structures, the interpreting physician relies extensively on the technologists’ notes and comments (often marked on the images). As a result, strong interpersonal/communication skills are required for all members of the lab.
Accreditation
Once operational, the most important task facing the vascular lab is to gain accreditation. Accreditation is designed to ensure adequate quality and safety for vascular testing at the facility. The most popular accreditation body is the Intersocietal Accreditation Commission (IAC). Another is the American College of Radiology (ACR). Regardless of the agency, achieving accreditation is arduous and time-consuming, but it remains the best way to demonstrate the lab’s commitment to quality. Furthermore, some payers require accreditation for reimbursement for tests performed at the vascular lab. Finally, all medical and technical staff should complete a certain number of hours of continuing medical education (CME) and laboratory quality improvement initiatives, as they are typical requirements of accreditation.
Testing and reporting standards
Standard elements for the performance of vascular lab testing are listed in detail by the IAC. 6 Standards for interpretation are selected by the medical and technical directors, and several are available.7,8 In accordance to IAC standards, reports should be finalized within 2 working days, and any critical findings (e.g., acute arterial or venous thrombosis, significant aneurysm, severely reduced ankle–brachial index/toe–brachial index [ABI/TBI]) should be reported immediately to the ordering physician. A critical values policy should be created to address these findings.
Coding and billing
Accuracy and completeness of coding and billing are also critical to the long-term success and financial sustainability of the vascular lab. In essence, the procedure codes (Current Procedural Terminology [CPT]) must align with the diagnosis codes (International Classification of Diseases, 10th Revision [ICD-10]), as outlined by CMS. 2 For example, if a physician wishes to order a bilateral carotid artery duplex US, the CPT code for the procedure is 93880 (‘Duplex scan of extracranial arteries; complete bilateral study’), and the ICD-10 codes that ‘support medical necessity’, as determined by CMS, include G45.3 (‘Amaurosis fugax’) or I65.22 (‘Occlusion and stenosis of left carotid artery’), but not I63.542 (‘Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery’) or I77.9 (‘Disorder of arteries and arterioles, unspecified’). Submitting ICD-10 codes that do not support medical necessity may result in denial of coverage of the procedure. 9 Because clinicians from many specialties routinely order vascular testing, some may not be aware of the nuances described above. A mechanism should be created for education and timely feedback/correction to ensure the appropriate ICD-10 code is mapped to the study ordered.
Marketing
It is important for colleagues and patients to be aware of the vascular lab’s core values, services provided, and contact information. Lab leadership should consider producing a flyer/brochure advertising this information. A dedicated webpage should also be created and maintained, either as a standalone website or as part of the practice/hospital website (two examples are included).10,11 Savvy promotion, combined with a friendly testing experience and high-quality scanning and reporting, will attract patients and referring physicians alike.
Challenges
Some of the common challenges of starting a vascular lab include initial overhead expenses, including but not limited to equipment, space, hiring vascular technologists, and the accreditation process. At some institutions, starting a new vascular lab may create competition with other departments such as diagnostic radiology. As a result, it is necessary to ensure the laboratory is sustainable with adequate study volume to balance the expense and time commitment.
Tips for vascular lab success
Know the customers and market to determine the optimal equipment and expertise needed.
Hire skilled and dedicated personnel, especially the technical director.
Adhere to the IAC vascular testing standards.
Foster communication among technologists and reading physicians.
Identify referral base and facilitate relationships with referring providers with optimal communication and service.
Interdisciplinary collaboration among cardiovascular specialists helps to improve patient care and the success of the vascular lab.
Conclusion
All vascular specialists interact with the vascular lab on a routine basis, and many would be tasked to start a lab or oversee its operation. By compiling regulatory policies and expert insights, we hope the above detailed summary provides a roadmap to vascular lab excellence.
Footnotes
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
