The care of venous disorders of the lower extremities has changed significantly in the last 25 years.
When venous care was done in hospitals, the professionals involved and the process of care were monitored using a variety of quality control measures. As care has moved to outpatient practices and away from hospital oversight, there is no easy way for patients to determine who provides safe and quality care. In addition, providers from multiple specialties, many of whom had no prior background in vein disease, have become involved in vein care. The participation of physicians from diverse primary disciplines is not a bad thing: in fact, it is the diversity of backgrounds that has moved vein care so far forward in such a short time. This influx of physicians with varying levels of venous education, training and experience has contributed to a wide variability in practice standards in our communities. This presents challenges to patients seeking safe and effective treatment as well as for organizations trying to distinguish themselves and for referring physicians to know where to send their patients.
Credentialing practitioners is one way to address the challenges of variances in care and training. As we have seen in other clinical areas, it is difficult to develop a consensus on what constitutes adequate training and experience.
The American College of Phlebology and the Society for Vascular Medicine conceived the idea of a voluntary, inclusive vein care accreditation program administered by an independent accrediting organization and chose the Intersocietal Accreditation Commission (IAC), an organization with over 20 years of success with forming consensus standards among multidisciplinary board memberships, to oversee the fledgling accreditation process. The IAC has 36 different sponsoring medical societies including the SIR.
Accreditation overcomes many challenges to certification. Using standards created by the multidisciplinary board to establish the floor for safe and effective care, the process looks at the overall organization. The assessment examines the physical space, equipment, processes, protocols, quality programs and clinical outcomes as well as the training, skills and experience of the involved physicians, nurses and technologists. This approach has been an effective and established model for ensuring patient safety and minimal standards of care in many areas of health care.
The vein center
Standards—superficial venous disease
The standards consider three basic elements of a vein center’s practice. The first relates to the organization, the second considers the process and the third specifies the requirements for the center’s quality improvement program.
The board’s primary goal was to create minimal standards of care that would identify a safe and effective care facility, not to identify centers of excellence. Responsible for monitoring the progress of care in each specific clinical area, it provided for the opportunity to elevate the standards of care by consensus through an IAC protocol at a minimum every two years.
Centers could be accredited to provide superficial, deep or lymphatic care as separate elements or in any combination and that the capabilities of the center would be distinguished by the areas in which they attain accreditation; the superficial standards were developed first and a “Superficial Vein Center” accreditation is the only one available to this point.
Personnel
Each center is required to have a medical director who is responsible for ensuring the center’s compliance with the standards. The criteria below describe medical director eligibility:
Medical director requirements
- Valid medical license
- Must be or have been certified by the ABMS, AOA, RCPS or LCMD
- If certification is not active, letters of recommendation from physicians in their community are required
- Two years of clinical experience beyond GME training
- Basic life support certification
- Case volumes:
- 200 over the prior three years
- 50 in two of the four required center capabilities
- 100 cases over the prior three years if completed a residency or fellowship that includes venous disease and its interventional treatment and venous duplex imaging in its core curriculum
- Hands-on ultrasound skills documented during 100 diagnostic or therapeutic procedures
- 30 hours of venous specific CME needs to be documented (except for physician completing venous curriculum containing GME training in the prior five years)
Similar standards, with lower thresholds, were created for other staff physicians and provisional staff physicians (those just beginning vein care and under the mentorship of the medical director), as were training and experience standards for nurse practitioners, doctor of nursing practice, physician assistants, nursing staff and ultrasound technologists.
Organization
- Each center needs to have the capability to perform at least two of the four capabilities listed below.
- Sclerotherapy
- Ambulatory phlebectomy
- Saphenous vein ablation
- Surgical, thermal, chemical or endoscopic ablation
- Nonoperative management of C5 and C6 Chronic Venous insufficiency
- Compression Therapy
Each center is required to have performed at least 75 venous procedures over the preceding year in order to apply. A minimum of 25 procedures need to be in two of the four areas as delineated in the capabilities listed above.
The organization is required to use an American College of Radiology (ACR)- or IAC-accredited diagnostic ultrasound facility for diagnostic studies utilized by the center. This could be accomplished by accreditation of the vein center’s venous ultrasound program or by patient referral to an accredited venous ultrasound facility for their diagnostic examinations. Requirements for the physical facilities, equipment, administrative policies and protocols for procedures and venous care are also included.
Quality improvement
The standards require the use of the clinical component of CEAP (Clinical, Etiologic, Anatomic and Pathophysiologic) and the VCSS score for grading the severity of disease prior to and at some point following treatment. Assessments of patients and referring physicians to determine their level of satisfaction are required.
The use of a patient-reported outcome (PRO) measure before and after treatments was recommended as a valuable assessment of facility performance but not required at this point. Entering data into a national registry, as they become available, and comparing the outcomes of the vein center (such as VCSS and PRO and vein ablation rates) with national benchmarks was recommended but also not required at this point. At the current time, there are no accepted metric thresholds to define a standard of care. However, as data is accumulated in registries, thresholds may become defined and should be used by each center to determine their performance.
A policy for adherence to National Patient Safety Goals must be documented and include accuracy of patient identification, medication safety, infection control in accordance with CDC and OSHA guidelines and the use of a universal protocol.
Participation requires a quality improvement program that conducts documented internal reviews every six months including a review of the appropriate indications for treatment for consecutive procedures that result in review of at least 5 percent of the annual volume of cases or 30 consecutive cases whichever is higher. These meetings need to include peer review of outcomes and of complications.
The vein center accreditation: Conclusions
At this point, the IAC-Vein Center accreditation for Superficial Diagnosis and Management is a voluntary means by which a center can demonstrate to referring physicians and patients its commitment to quality venous care and it allows centers to distinguish themselves from others in their communities. This accreditation, like many before it, may become a benchmark for quality care accepted by insurance carriers to determine who they will work with.
