Standardizing Venous Ultrasound

Diagnostic testing, in any field, by definition, is used to detect, confirm or rule out the presence of a problem. Its purpose includes the ability to be reproducible and reliable. These characteristics put a heavy burden on diagnostic testing. In venous ultrasound, this picture becomes even more complicated; the testing requires a human to perform the test and testing is done on ever-changing human subjects. Not every patient presents the same. Not every patient has the same findings. Therefore, not every treatment is the same.

Given these circumstances, there has been a huge push to standardize venous ultrasound and care. Standardizing venous nomenclature, venous mapping and treatments have initially contributed to discrepancies in the care of venous disease. Unfortunately, this has also delayed care for patients. Primary care providers are lagging in knowledge; the standard of care in venous disease is impaired where early recognition suffers.

There have been many initiatives to close these gaps from professional societies, accreditation organizations and patient advocacy/education pieces via social media, podcasts, TV commentaries, and radio appearances. Despite these advances and ongoing research, the heart of the matter seems to come down to diagnostic testing in venous disease: the ultrasound. The same critique cannot be said for MRI, CT scan, PET scan, DEXA scan or even the simple thermometer. Though we need humans to perform these standardized tests, there is, perhaps arguably, less possible human error. There is some automation to many diagnostic testings. Venous ultrasound, however, is heavily dependent on the performer. Therefore, there is perhaps a stronger argument to standardize venous ultrasound, including venous mapping.

Many colleagues have discussed the wide range of venous mappings seen between hospitals and private practices. Patients may be sent to the outpatient radiology department to rule out a deep vein thrombosis (DVT); the superficial venous thrombophlebitis is not mentioned in the report or even imaged/investigated. Standardizing reports is essential in diagnostic testing, making the test more reliable and reproducible. However, deciding on what the standard should be, especially in venous mapping, is more challenging than just the report wording.

Changes in nomenclature, which have been more so over the last two decades, have left some reports still calling the Small Saphenous Vein, the Lesser Saphenous Vein, and the Great Saphenous Vein, the Greater Saphenous Vein. Newer nomenclature that includes less historical perforator vein nomenclature and more location-based has allowed more specificity to ultrasound findings.

In addition to nomenclature, mapping details have included the presence or absence of junctional reflux. There also has been literature to support vessel size and correlation to probable reflux.

Nomenclature, location of incompetent veins and vessel size, to name a few, are easy targets to beat up the diagnostic testing of venous ultrasound. However, there also lies an opportunity to standardize venous ultrasound and mapping.

The Role of the Intersocietal Accreditation Commission

Accreditation, like the Intersocietal Accreditation Commission (IAC), allows standardization from multiple angles. Not only are there staff requirements and continuing education requirements; there are also documentation requirements when it comes to vascular and vein center protocols. Minimal requirements for documentation give a base for standardizing reporting.

In addition to venous mapping protocols, the IAC can serve many practices as a guide to set up protocols for venous procedures including sclerotherapy, ambulatory phlebectomy, endovenous laser ablation and more. Guidelines for OSHA logs and assuring practices are following manufacturer guidelines for autoclaving are just two examples that are commendable in the requirements for standardizing venous medicine. IAC accredited labs also maintain nomenclature and reporting standards that are supported by the literature.

Hurdles to Overcome

Despite the many “perks” of accreditation, a few hurdles also exist for many practices. Though now officially most physicians are employed, many are still maintaining costs of an electronic medical record, image storage, staff CME and many other expenses. Just as many hospitals have taken these burdens away from physicians, many phlebologists have also joined large vein center conglomerates to lose those same burdens. Image storage solutions are not cheap and many do not communicate with EHRs to allow a seamless chart for a patient. Practices are then left with server expenses or cloud storage expenses. Perhaps accreditation organizations like the IAC can push companies to create solutions for image storage.

Aside from those burdens, staffing burdens exist as well. Many ultrasonographers are not trained in venous mapping and reflux studies. Schooling does involve vascular/venous ultrasound – to rule out a DVT. On the job training oftentimes fine-tunes these skills for sonographers and their skill set is far more comprehensive and clinically significant. The protocols set forth in accreditation allow, again, a base for the sonographer to learn and then finesse the study depending on the patient’s presentation and protocols developed in the laboratory they are involved/employed with. In addition to these standards set forth for mapping and reporting, there is still room for labs to create additional protocols and reporting to meet the needs of their patients.

Vein Center accreditation also requires on-site visitation where ultrasound images, reports and procedures can all be observed and evaluated. This allows immediate feedback and assessment of processes in some regards (official delinquencies are outlined in a letter later after the visit) in a non-threatening environment.

Conclusion

In the end, the work for accreditation does allow standardization across staffing, facility, reporting, and quality, giving practices tools for success. It is time-consuming and is not tied to reimbursement amounts. However, many insurance companies are requiring accredited labs perform vascular and vein mapping studies. The extra meetings and quality measures required are not reimbursable energy spent. However, the moral obligation seems undeniably satisfied when accredited facilities are closing the gap on diagnostic testing in venous disease.

Basic Outline of Vein Center Accreditation Requirements*

*Details of each requirement can be found on the IAC website, https://www.intersocietal.org/. What's here is a rough outline that does not include every requirement in detail.

Part A: Organization

Personnel and Supervision

Section 1A

Medical Director

3 years of experience/training

200 cases in at least 2 out of 4 categories with case log of 50 in each of the 4 categories

If ACGME approved residency, 100 cases in at least 2 out of 4 categories with a case log and 50 in each of the 4 categories

100 cases of diagnostic ultrasounds documented

CME requirements

BLS (ACLS with IV sedation)

Administrative duties to ensure protocols are followed and Quality Improvement (QI)

Medical Staff

Similar to Medical Director requirements, but less case volume/log

Must be involved in QI

Can be provisional while case volume is met

Advanced Practice Provider (PA, NP, DNP)

Similar requirements to the Medical Staff

BLS (ACLS with IV sedation)

QI

Nursing

50 cases of sclerotherapy over 3 years documented

20 cases of wound debridement over 3 years documented

Provisional staff is allowed as case log is achieved

CME

Sonographer

Registered Vascular Technologist (RVT)

Registered Vascular Specialist (RVS)

Registered Technologist Vascular Sonography (RTVS)

Registered Phlebology Sonographer (RPhS)

100 cases over 3 years (½ reflux, ½ diagnostic venous)

CME

Sterile technique

Ancillary

Ensuring they can provide care in your facility

Part A: Facility
Section 2A

Physical Space

Bathroom

Waiting Area

Exam Rooms

Procedure Rooms

Equipment and Instrumentation

Crash Cart

Ultrasound

Part A: Administrative
Section 3A

Patient confidentiality

Protocol

Patient Complaints

Protocol

Primary Source Verification

Protocol

Record Retention

Five years of charts

Part B: Processes

Pre-Procedures

Veins to be examined:

  • great saphenous vein
  • popliteal vein
  • small saphenous vein

Additional images to document areas of suspected reflux and as required by the protocol

Spectral Doppler waveforms with the extremity(s) in a dependent position and documented as required by the protocol and must include at a minimum small saphenous vein at the saphenopopliteal junction if visualized

common femoral vein

saphenofemoral junction

great saphenous vein at proximal thigh

great saphenous vein at knee

femoral vein mid-thigh

popliteal vein

small saphenous vein at saphenopopliteal junction if visualized; if not visualized there, the small saphenous vein at the proximal calf must be documented

additional waveforms as required by the protocol

Transverse grayscale images of diameter measurement must be documented as required by the protocol and must include at a minimum: saphenofemoral junction; great saphenous vein at proximal thigh; great saphenous vein at the knee.

Procedure Documentation

Procedure language/wording requirements for each type (sclerotherapy, ambulatory phlebectomy, EVTA, NTNT

Procedure Volumes

75 cases in one year with 2 out of the 4 categories

25 in each of the 4 categories

Part C: Quality Improvement

General measures

Performance of procedure, appropriateness, patient safety

Oversight

Medical Director and Technical Director

QI meetings

Documented

Dr. Manu B. Aggarwal, MHSA, MD heads the Vein Care Center in Lima, Ohio, and she brings an amazing combination of precise skill and experience to the practice. Her compassionate nature shines through, and her friendly care has allowed patients to be relieved of their discomfort while eliminating the risks that are associated with chronic vein disease.