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Vein Center Accreditation allows practices to share their commitment to venous care with comprehensive evaluation and treatment. This year, Blue Cross Blue Shield (BCBS) of Massachusetts was the first state to require endovenous laser treatments to be performed only in Vein Center Accredited facilities. They had required this accreditation to be achieved by September 1, 2015; however, they have now extended it to Jan. 1, 2016.

An accredited Vein Center is defined as a center where venous evaluation and management and/or treatment procedures are performed. The Intersocietal Accreditation Commission (IAC) accredits facilities that provide venous evaluation and management and/or treatment procedures. IAC accreditation is a voluntary process by which vein centers can evaluate and demonstrate the level of patient care they provide.

Tips and pearls we found helpful for and during our accreditation process:

1. Have a recoverable and reviewable image storage database.
Like a lot of older practices, our ultrasound images started with printing. We then moved to storing them on a server. The server died. Then someone hacked into our server. We are now finally using a HIPAA-compliant cloud-based image storage system.

Yes, this was an expensive process to say the least; however, we could have saved a lot of money by skipping the servers. Servers break, last an average of 5 to 7 years and require maintenance throughout their life. All of these costs are the practice’s responsibility. Last we checked, physicians do not specialize in computer information systems. For our practice, our state medical association (Ohio), for a nominal fee (with a third-party organization) also confirmed for us that our cloud-based storage was HIPAA-compliant.

2. Use a calendar to remind you of important dates/task list.
If you use an online calendar, place all annual/monthly checks in the calendar and label the calendar IAC Vein Center Accreditation. Most calendars can now be synced with your tablet and phone. This keeps your To Do list at your fingertips. Share the calendar with your key people (practice manager, technical and medical director, ultrasound technicians, etc.) so they all are updated on meetings, peer review due dates, etc.

3. Engage your entire staff so they are aware of changes/rules to follow.
Keeping your nonclinical staff aware of changes and rules allows them to have confidence in the practice and the services you provide to patients. Have your front desk staff sit in on an initial consult, ultrasound, procedure and follow-up visit. When patients call and ask questions about their appointment, the staff will be better able to answer questions and even boast about your accreditation.

4. Use a consultant.
An accreditation consultant can be very helpful in making sure all the details have been met. The consultant is very helpful in correcting and providing solutions to shortcomings in documentation, procedural policies and more. They also can contact IAC to clarify questions prior to the application submittal and then again prior to the site visit. Though you can contact IAC yourself, the consultant can serve as a great liaison through the accreditation process from start to finish.

5. Keep organized records.
Don’t underestimate the power of documentation. Document your procedures (sclerotherapy, endovenous treatments, ambulatory phlebectomy, ultrasound guided sclerotherapy) at the end of each week. We use a simple binder and handwrite any small nuances that may have occurred to review at our biannual quality meeting. This also makes it easy when doing monthly peer reviews of procedures.

In addition, keep records of your patient surveys to review at quality meetings. Designate a non-clinical staff member for such records. Binders are very easy to flip through when trying to find something quickly and easily. It is also easy to organize your policies and procedures based on IAC standards when kept in the same order as the standards. VTN

Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio, with a satellite office in Celina, Ohio.

Ashley Watercutter, BS, RVT, CCT, is a registered vascular technologist and technical director of the IAC Accredited Ultrasound Laboratory.


AngioDynamics, a provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, is shipping the BioFlo Midline catheter indicated for short-term intravenous therapies. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the BioFlo Midline catheter earlier this year.

The BioFlo Midline catheter often delivers the same medications, including a variety of antibiotics, as a peripheral intravenous catheter (PIV.) However, Midlines can provide access for up to 30 days while PIVs typically need to be replaced every couple of days, usually due to performance failure. Midline catheters are ideal for patients who may require more than five days of intravenous therapy.

"The BioFlo Midline catheter is a logical extension of the BioFlo product line, bringing the clinically relevant thrombus reduction properties to patients needing shorter term vascular access to deliver infusion therapies," said Chuck Greiner, AngioDynamics' senior vice president, Global Franchise Leader. "Its increased period of functionality improves patient satisfaction by lowering the number of needle sticks and interruptions to treatment. Similarly, it offers health care providers an expanded range of patient treatment options that help to increase staff efficiency and reduce the overall cost of care. We see BioFlo as the future of intravenous therapy delivery and our customers agree."

The BioFlo Midline catheter with Endexo Technology is indicated for short-term or up to 30 days of peripheral access to the venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood and for power injections of contrast media.

Joseph M. DeVivo, AngioDynamics' president and CEO, said BioFlo product line sales grew at a double digit rate last fiscal year. “And the Midline's launch, along with continued account wins and market penetration, position us for additional solid BioFlo growth this fiscal year."


The U.S. Food and Drug Administration (FDA) has approved Merz North America’s injectable dermal filler Radiesse for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4. "Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year," a company spokesman said. Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation — and is approved in 52 countries for that indication.

Data to support FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks.

The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) — validated by the company in another study — and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results.

According to the scale, 75 percent of Radiesse patients experienced at least a one-point improvement at three months compared with 3 percent of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.

In addition, 98 percent of treated patients reported improvement in the appearance of their hands at three months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the spokesman said.

Most adverse events were injection site reactions such as swelling, redness, pain and bruising, which were usually mild to moderate, short in duration (lasting about a week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company.

Radiesse is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.


The third stage of the Meaningful Use program could leave even tech-savvy providers unable to meet requirements, as they must depend on the health IT adoption of others, says Niam Yaraghi, a fellow at the Brooking Institution's Center for Technology Innovation.

Stage 3 of Meaningful Use requires that providers send electronic summaries for patients they refer to other providers, receive summaries for patients referred to them and reconcile former patient data with newer reports, Yaraghi wrote in a U.S. News and World Report. However, if other providers do not have the ability to send or receive those summaries, which is required to meet Meaningful Use Stage 2, the second and third requirements of Stage 3 cannot be completed, he says.

In addition, the rule requires that providers ask new patients to say who their previous physicians were in order to obtain the care summaries, which "ignores that fact that in many critical instances patients are unable to recall all the medical providers whom they have previously visited," Yaraghi stated.

"Given the distance between the proposed rules of the Meaningful Use program and the reality of the healthcare market, the program's success should be considered a miracle," he writes. "Even if this miracle happens, we will not achieve much in terms of quality or efficiency in the healthcare system."

Yaraght isn't the only critic of the third and final stage of the program. The American Medical Association (AMA) and the Medical Group Management Association (MGMA), among others, are calling for a delay to the rule. AMA says the program "will create significant challenges for physicians, patients, and vendors." In addition, MGMA says Stage 3 could result in a failure to meet the goals outlined in the American Recovery and Reinvestment Act of 2009. It should be delayed, MGMA says, until it is known what the impact of Medicare Access and CHIP Reauthorization Act of 2015 will be.


Baxter International Inc. is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.

Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

The lot being recalled, C964601, was distributed to customers and distributors nationwide between Jan. 22 and Feb. 12. For further information, contact Baxter Healthcare Center at 1-888-229-0001, email or see

Featured Contributor

Deborah Manjoney, MD, FACS, RPVI

Deborah Manjoney, MD, FACS, RPVI, opened the Wisconsin Vein Center and MediSpa in 2002, and in 2004 she left her 18-year practice in cardiovascular and thoracic surgery to devote herself to fulltime practice of phlebology. She was one of the first in the area to add the “medispa” concept to her practice. Please see her comprehensive aticle on what has happened to all the government regulations this year on Page 1.

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