by Neil Khilnani, MD
The History Behind Venous Practice Accreditation
The care of venous disorders of the lower extremities has changed significantly in the last 25 years. Treatment for nearly all chronic superficial and a growing fraction of deep venous disease now involves minimally invasive procedures that can be done with no sedation and immediate ambulation. This has been a tremendous improvement for patients and transformative for the care they can now receive. Many patients who were reluctant to undergo treatment in the past are now benefitting from these simpler, more targeted and easier to tolerate treatments performed in less intimidating and more efficient environments.
Unfortunately, these advances have brought new and often not obvious risks for these same patients. Increasingly, providers from multiple specialties who had no prior background in vein disease have become involved in vein care. Although such physicians can provide excellent care, 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. When venous care was done in hospitals, the professionals involved and the process by which their care was delivered were monitored using a variety of quality control measures. As venous care has moved out of the jurisdiction of hospital oversight, there has been little way for patients to determine which caregivers and organizations are providing quality care. It has also made it challenging for qualified organizations to distinguish themselves and for referring physicians to know where to send their patients.
These potential risks to patient safety and quality of care have been discussed in this journal before. As previously noted, credentialing of practitioners, one way to address this issue, is a very challenging endeavor. The primary issue-is the difficultly to develop a consensus on what constitutes adequate training and experience. We know that many of the advances in vein care have evolved from the participation of physicians from diverse primary disciplines. In fact, it is the diversity of backgrounds that has moved vein care so far forward in such a short time. The problem is that there are venous practitioners from every specialty that do not have the necessary understanding of the entire disease process or the necessary experience with the diagnostic and therapeutic tools required for caring for these patients. Moreover, simply certifying providers still does not ensure quality care, as it does not assess patient care processes or outcomes. Finally, standards developed for physician certification have associated legal issues related to restriction of practice that are vulnerable to challenge.
Accreditation of treatment facilities gets past many of the hurdles that have challenged certification. Accreditation looks at the overall organization: the physical space and equipment, processes, protocols and outcomes and, in addition, the practitioners. This has been an effective and established model for ensuring patient safety and minimal standards of care. There are many examples of highly successful and widely accepted health-care related accreditation programs including the Joint Commission.
The “Vein Center”
The leadership of the American College of Phlebology and Society for Vascular Medicine had their first conversations about developing a voluntary vein care accreditation in 2010. The group felt strongly that the process needed to be inclusive of all specialties involved in vein care. It should utilize standards created by vein care experts from all of the disciplines treating venous disease and utilize an independent accrediting organization. After careful consideration, the Intersocietal Accreditation Commission (IAC) was selected for this purpose. This organization had over 20 years of success with forming consensus standards amongst multidisciplinary board memberships, and possessed the required structure and oversight resources and capabilities. It also had the necessary recognition by the medical community, government and the insurance industry. It began in 1990 with the accreditation of vascular diagnostic centers. At that time it was known as ICAVL (Intersocietal Commission for the Accreditation of Vascular Labs) and developed its reputation in this area. More recently, it has diversified and, as an example, has become the dominant accrediting body for echocardiography and also accredits a large number of nuclear medicine facilities as well. It has 36 different sponsoring medical societies including the ACP, AVF and SIR.
The first function of the IAC in developing the venous for vein treatment centers was to create an inclusive Board. The IAC sent letters to all societies involved in vein care and invited them to participate on the Board, recognizing that the validity of the accreditation was dependent on securing the buy-in of all of the groups involved in vein care. Any society that was interested could have up to two seats on the Board. Each society made a financial commitment to start the development of the program. Follow-up communications in the form of letters, emails and phone calls were made to stakeholders who did not initially respond to the IAC’s requests. The result of this process was the Board whose names and sponsoring organizations are listed in Table 1.
The Board had its first face-to-face meeting in June of 2012. The first line of business was to determine what the scope of the accreditation would be, as well as the name of the accreditation, which would reflect its scope. When discussing the scope of the accreditation, the group universally accepted that superficial, deep and lymphatic diseases are clinically intertwined, and that it is often difficult for less initiated physicians and patients to distinguish between them. In addition, it was evident that creating a single standard to cover all aspects of venous care would be challenging to write. Moreover, the capabilities to care for all of these disease entities would be challenging to meet by a sufficient number of vein care practices as they exist today, which would render the accreditation process useless. Ultimately it was decided that 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. Given the large scope of developing these standards, the Board decided to begin by developing the superficial standards first. After some debate, the name Vein Center was adopted along with a definition of the entity we were describing.
It was universally accepted that the goal was to create minimal standards of care that would identify a safe and effective care facility and emphasized that the accreditation process was not designed to identify centers of excellence. It was recognized that the Board was responsible for monitoring the progress of care in this clinical area and had the opportunity to elevate the standards of care by consensus when the standards are reconsidered by IAC protocol at a minimum of every two years.
The first draft of the standards was completed in June of 2013. The draft of the IAC Standards for Vein Center Accreditation: Superficial Venous Evaluation and Management was forwarded to each of the sponsoring organizations for comment. After review of the comments, revisions were made and the final Standard was completed at the UIP in September 2013 and published October 1, 2013. The online application for accreditation for Vein Center- Superficial Venous Evaluation and Management launched on November 4, 2013
Vein Center Standards- Superficial Venous Disease
As an overview, the Standards consider three basic elements of a Vein Center’s practice. The first relates to the organization and includes description of the necessary personnel, facility and equipment. The second considers the process, looking specifically at the capabilities and volumes of the Center. Finally, the standards specify requirements for the Center’s Quality Improvement program.
Each Center is required to have a Medical Director (MD) who is responsible for ensuring the Center’s compliance with the Standards. The criteria for who is eligible to be a Medical Director are included in Table 2.
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 are required
• Two years of clinical experience beyond GME training
• Basic life support certification
• Case volumes:
- 200 over the prior 3 years
- 50 in two of the four required Center capabilities (Table 3)
- 100 cases over the prior 3 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 5 years)
Vein Center Capabilities:
2. Ambulatory phlebectomy
3. Saphenous vein ablation
a. Surgical, thermal, chemical or endoscopic ablation
4. Non-operative management of C5 and C6 Chronic Venous insufficiency
a. Compression therapy
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). Required training and experience standards were also created for nurse practitioners, doctors of nursing practice, physician assistants, nursing staff and ultrasound technologists.
Each Center needs to have the capability to perform at least two of the four capabilities listed in Table 3. In addition, 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 in Table 3. This volume level and distribution was an area of controversy for the Board and these will likely be readdressed with the next cycle of review of the standards. It is possible these requirements may increase.
The Standards require the organization to use an American College of Radiology or IAC accredited diagnostic ultrasound facility for diagnostic studies utilized by the Center. This could be accomplished by accreditation of the Veins Center’s venous ultrasound program or by patient referral to an accredited venous ultrasound facility for their diagnostic examinations.
The Standards also outline requirements for the physical facilities, equipment, administrative policies and protocols for procedures and venous care. Specific items worth mentioning are the presence of emergency equipment and drugs, adequate ultrasound equipment, autoclave and sterilization procedures for Vein Centers that use nondisposable instruments for ambulatory phlebectomy and wound care, as well as protocols for the use and maintenance of all medical equipment.
The standards require the use of the clinical component of CEAP and the VCSS score for grading the severity of disease prior to and at some point following treatment. The use of a patient reported outcome (PRO) measure before and after treatments was recommended. Although PRO use is not required, this later metric of patient status was recognized as a valuable assessment of facility performance. The requirement of its use is likely to be reconsidered at the next review of the standards.
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. 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.
Finally, the Standards require a QI program that conducts documented internal reviews every six months including a review of the appropriate indications for treatment for consecutive procedures that results in review of at least 5% of the annual volume of cases or 30 consecutive cases which ever is higher. These meetings need to include peer review of outcomes and of complications.
The IAC has an online application for initiating the process of accreditation through completion of qualifying questions and documentation. Each applicant Vein Center will be required to submit a case and complication log for review. For practices meeting the Vein Center eligibility, the IAC will request the medical records for all encounters for three patients they select for more detailed review. This is likely to include a case identified from the complication log. A group of IAC Vein Center Board members will then review the medical records to determine if the Standards of care are being adhered to. After this, a request for more records or recommendations for process improvement may be required for situations where the reviews need more information or if the center has not clearly documented compliance with the Standards. For those who pass this stage, a site visit is performed of each applicant Vein Center by a member of the IAC clinical staff and one additional trained medical professional with vein care expertise. During the site visit, the facility and equipment will be examined, the MD and staff interviewed and protocols and procedures may be requested for examination.
A few weeks after the site visit, the results are again reviewed by the IAC Vein Center Board and a decision is rendered. The accreditation of the Center is for three years. The current application fee is $6000 and is inclusive of the site visit and any required midcycle audits or site visits over the three year period.
IAC Vein Center accreditation for Superficial Diagnosis and Management is now a reality. It is a voluntary means by which a Center can demonstrate to referring physicians and patients its commitment to quality venous care and thus distinguishing itself from other practices. It is based on minimal standards for quality developed by an inclusive multidisciplinary group of vein experts. It is hoped that this accreditation will elevate the standard of vein care. It may become a benchmark by which patients and potentially their insurance carriers determine which providers are offering the type of care they want to purchase.