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The IAC Standards and Guidelines
for Vein Center Accreditation:

Superficial Venous Evaluation and Management

 

Click here for a printer-friendly PDF of the Vein Center Standards

Part B:
Process

Section 1B: Procedures

STANDARD – Procedure Overview

 

1.1B           These Standards include, the minimum requirements for the performance of the following superficial venous procedures:

 

1.             Sclerotherapy

2.             Ambulatory phlebectomy/powered phlebectomy

3.             Saphenous vein ablation

a.        may include surgical, endovenous thermal, endovenous non-thermal and/or ultrasound-guided chemical ablation

4.             Non-operative management of chronic venous insufficiency with ulceration (CEAP Clinical classification C6)

a.        wound care

b.       debridement/bandaging and compression therapy

 

1.2B           General Required Documentation

 

1.2.1B            Pre-Treatment Documentation

 

1.2.1.1B             A clinical evaluation of each patient being considered for treatment must be performed and documented in their medical record and must include, but is not limited to:

 

i.               a histo­­ry of the venous disorders

·         clinical class score (CEAP) and Venous Clinical Severity Score (VCSS) at baseline for the affected limb or limbs, repeat at completion of treatment or as indicated

·         a review of past medical history

o    medications

o    allergies

·         venous history

o    family history of venous disease

·         prior venous treatments, including outcomes of those treatments

o    include prior use of compression

·         previous venous imaging studies, if available for review

ii.             additional laboratory, imaging and/or consultations, as indicated

iii.           a directed physical exam

iv.           functional (reflux) ultrasound of the superficial, perforator and deep veins

v.             treatment plan

vi.           pre-treatment photographs

 

1.2.1.2B             Any changes in medical history, medications, allergies must be documented with each encounter.

1.2.1.3B             Must use accepted nomenclature for anatomy.

 

1.2.1.4B             Duplex ultrasound imaging of the venous system must be performed prior to treatment for all patients with C2 or higher disease and as indicated in selected patients with C0 or C1 disease.

 

i.               Must use an IAC or American College of Radiology (ACR) accredited facility for venous duplex ultrasound diagnostic testing.

 

1.2.2B            Lower extremity venous duplex for reflux must include:

 

1.2.2.1B             Transverse grayscale images without and with transducer compressions (when anatomically possible or not contraindicated) must be documented as required by the protocol and must include at a minimum:

 

i.              common femoral vein;

ii.            saphenofemoral junction;

iii.           proximal femoral vein;

iv.           mid femoral vein;

v.            distal femoral vein;

vi.           great saphenous vein;

vii.           popliteal vein;

viii.         small saphenous vein;

ix.             additional images to document areas of suspected reflux and as required by the protocol.

 

1.2.2.2B             Spectral Doppler waveforms with the extremity(s) in a dependent position (refer to section 1.2.2.5B), demonstrating baseline flow and response to distal augmentation and if reflux is present, duration of retrograde flow must be measured with calipers and documented as required by the protocol and must include at a minimum:

 

i.              common femoral vein;

ii.            saphenofemoral junction;

iii.           great saphenous vein at proximal thigh;

iv.           mid femoral vein at knee;

v.             femoral vein mid thigh;

vi.           popliteal vein;

vii.         anterior accessory saphenous vein (when identified);

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

ix.            perforator vein waveforms in the setting of active or healed venous ulcers, as required by the protocol;

x.             additional waveforms as required by the protocol.

 

1.2.2.3B             Transverse grayscale images of diameter measurement must be documented with the extremity(s) in a dependent position and must include at a minimum:

 

i.               saphenofemoral junction;

ii.             great saphenous vein at proximal thigh;

iii.           great saphenous vein at knee;

iv.           anterior accessory saphenous vein (when identified);

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

 

1.2.2.4B             Proper measurements as required by the protocol:

 

i.               vein diameter measurements must:

·         be acquired with the extremity(s) in a dependent position;

·         be acquired in transverse anterior wall to posterior wall, consitently, or as required by the protocol;

·         as required by the protocol for active or healed venous ulcers, perforator vein diameter measurements must be acquired where the perforator traverses the deep fascia;

·         assure that no external pressure is applied to the vein.

1.2.2.5B             Proper patient positioning:

 

                                                            i.               The limb must be placed in a dependent position. Standing in the preferred position if not constrained by the patient's physical condition. Sitting or reverse Trendelenburg may be used if the patient cannot stand. Patient position must be noted in the final report.

STANDARD – Procedure Requirements

 

1.3B           Required Pre-Procedure Documentation:

 

1.3.1B            Must be documented in the medical record:

 

1.3.1.1B             Procedure-specific informed consent

 

1.3.1.2B             Assessment and documentation of the correct patient, site and procedure immediately before initiation of the procedure

 

1.4B           Required Procedure Documentation:

 

1.4.1B            Must include and be documented in the medical record:

 

1.4.1.1B             a summary of the procedure;

 

i.               Documentation may be facilitated by recording a diagram of the extremity treated.

 

1.4.1.2B             any immediate complications or adverse events;

 

1.4.1.3B             the patient’s status at the end of the procedure;

 

1.4.1.4B             total volume of sclerosants(s);

 

1.4.1.5B             sclerosant concentration(s);

 

1.4.1.6B             ultrasound-guidance (if used);

 

1.4.1.7B             veins treated (spider, reticular, varicose tributaries, great saphenous, small saphenous, perforator, etc.);

 

1.4.1.8B             laterality and site(s).

 

1.5B           Required Post-Procedure Documentation and Patient Instructions:

 

1.5.1B            Must include and be documented in the medical record:

 

1.5.1.1B             procedure performed;

 

1.5.1.2B             post-procedure care and expectations;

 

1.5.1.3B             possible adverse events or complications which may require contact with a health care provider;

 

1.5.1.4B             directions for contact to provider or covering medical team at any hour

 

1.5.1.5B             contact information to access the health care team;

 

1.5.1.6B             dressings and wound care;

 

1.5.1.7B             type and duration of compression;

 

1.5.1.8B             patient activity, ambulation and exercise;

 

1.5.1.9B             air and car travel restrictions;

 

1.5.1.10B          management of post-procedure pain;

 

1.5.1.11B          follow-up duplex ultrasound exam appointment, if appropriate;

 

1.5.1.12B          A follow-up appointment (as required by the facility's protocol) either in person, by telephone, or electronic communication with a medical staff member, Advanced Practice Provider, or nursing staff member must be documented and include outcomes.

 

1.5.2B            A record of specific complications post-procedure complications:

 

1.5.2.1B             allergic reactions;

 

1.5.2.2B             deep vein thrombosis;

 

1.5.2.3B             extension of thrombus into the deep veins, Endovenous Heat Induced Thrombus (EHIT);

 

1.5.2.4B             skin burns and parasthesias;

 

1.5.2.5B             wound infections.

 

1.6B           Sclerotherapy:

 

1.6.1B            Prior to Performance of the Procedure:

 

1.6.1.1B             Appropriate pharmacologic agents, as defined by the procedure:

 

i.               an adequate supply of sclerosants;

ii.             if an FDA-approved liquid sclerosant is available, it must be used rather than a compounded version of the same agent.

·         Compounded sclerosants may be used when a higher concentration is needed for an individual patient than is available in an FDA-approved sclerosant.

iii.           premixed solutions must be dated and marked to identify the sclerosant and the sclerosant concentration;

iv.           must follow manufacturer recommendations regarding agent expiration date.

 

1.6.1.2B             Multiuse vials must be marked with the drug name, concentration, date of creation, initials of who made it and expiration date.

 

i.               A new needle and syringe must be used for every entry into the vial.

ii.             The vial stopper must be disinfected with an alcohol swab or equivalent antiseptic prior to entry.

iii.           To avoid contamination, venting needles or other objects may not be left in the stopper.

 

1.6.1.3B             Appropriate supplies, as defined by the procedure:

 

i.               lighting, magnification, gauze, syringes, needles, gowns, gloves, eye protection, etc.;

ii.             ultrasound imaging equipment.

 

1.6.2B            During the Performance of the Procedure:

 

1.6.2.1B             Sclerotherapy technique procedure must be performed using clean technique.

 

1.6.2.2B             During ultrasound-guided chemical ablation, visualization of proper needle placement and sclerosant delivery must be observed into the target vein.

 

1.6.3B            Sclerotherapy Procedure-Specific Documentation:

 

1.6.3.1B             Required procedure-specific documentation must include:

 

i.               total volume of sclerosants(s);

ii.             sclerosant concentration(s);

iii.           ultrasound-guidance (if used).

 

1.7B           Ambulatory Phlebectomy:

 

1.7.1B            Prior to Performance of the Procedure:

 

1.7.1.1B             Appropriate surgical instruments, as defined by the procedure.

 

1.7.1.2B             Appropriate supplies, as defined by the procedure:

 

i.               gauze, syringes, needles, gowns, gloves, mask, eye protection, sterile drapes, etc.

 

1.7.1.3B             Appropriate pharmacologic and anesthetic agents, as defined by the procedure:

 

i.               premixed pharmacologic and/or anesthetic agents must be labeled with content, concentration and expiration date if not prepared immediately before use.

 

1.7.1.4B             Ultrasound imaging equipment or transillumination device, as defined by the procedure.

 

1.7.1.5B             Varicose veins must be marked immediately prior to the procedure. 

 

1.7.1.6B             Sterile prep of the treatment area.

 

1.7.2B            During the Performance of the Procedure:

 

1.7.2.1B             Appropriate ambulatory phlebectomy technique using hemostatic compression.

 

1.7.3B            Ambulatory Phlebectomy Procedure-Specific Documentation:

 

1.7.3.1B             Required procedure-specific documentation must document:

 

i.               any use of ultrasound-guidance;

ii.             location of varicosities;

iii.           number of incisions;

iv.           pharmacologic and/or anesthetic agents used, including the volume and concentration of tumescence.

 

1.8B           Endovenous Thermal Ablation (EVTA)

 

1.8.1B            If endovenous LASER is performed, the LASER must be U.S. Food and Drug Administration (FDA) cleared.

 

1.8.1.1B             Eye protection for the specific LASER wavelength must be used by all staff in the room and the patient.

 

1.8.1.2B             LASER safety signage must be displayed in accordance with Occupational Safety and Health Administration (OSHA) and state regulations.

 

 

1.8.2B            If endovenous radiofrequency is performed, the radiofrequency generator with appropriate catheters must be FDA approved.

 

1.8.3B            Prior to Performance of the Procedure:

 

1.8.3.1B             Appropriate surgical instruments and supplies to include, but are not limited to:

 

i.               sterile thermal ablation tools;

ii.             associated generator equipment.

 

1.8.3.2B             Appropriate supplies as defined by the procedure:

 

i.               gauze, syringes, needles, gowns, gloves, mask, eye protection, sterile drapes, etc.

 

1.8.3.3B             Appropriate pharmacologic and anesthetic agents and supplies:

 

i.               premixed pharmacologic and/or anesthetic agents must be clearly labeled.

 

1.8.3.4B             Ultrasound imaging equipment as defined by the procedure.

 

1.8.3.5B             Sterile prep of the treatment area.

 

1.8.4B            During the Performance of the Procedure:

 

1.8.4.1B             Adherence to IFU (instructions for use) or published guidelines for the performance of all ablation procedures. 

 

1.8.4.2B             Visualization of proper catheter placement into the target vein with ultrasound-guidance. 

 

1.8.5B            EVTA Procedure-Specific Documentation:

 

1.8.5.1B             Required procedure-specific documentation must include:

 

i.               pharmacologic and/or anesthetic agents used, including the volume and concentration of tumescence;

ii.             use of ultrasound-guidance;

iii.           the starting and ending time of treatment;

iv.           the length of vein treated;

v.             catheter insertion site(s);

vi.           the energy deposited, RF cycles used or RF time; LASER Joules.

 

Comment: If concurrent ambulatory phlebectomy or sclerotherapy is performed all elements of their protocols and documentation need to be maintained as well.

 

1.9B           Endovenous Non-Thermal Non-Tumescent Ablation (NTNT) Procedure

 

1.9.1B            If endovenous non-thermal non-tumescent ablations are performed, the method, product and required instrumentation must be U.S. Food and Drug Administration (FDA) cleared, or used with an appropriate Investigational Device Exemption (IDE) or in a clinical trial.

 

1.9.2B            Prior to Performance of the Procedure:

 

1.9.2.1B             Appropriate instruments and supplies to include, but are not limited to:

 

 

i.               sterile ablation tools;

ii.             associated equipment.

 

1.9.2.2B             Appropriate supplies as defined by the procedure:

 

i.               gauze, needles, gowns, gloves, mask, sterile drapes, etc.

 

1.9.2.3B             Appropriate pharmacologic agents and supplies:

 

i.               ultrasound imaging equipment as defined by the procedure;

ii.             sterile prep of the treatment area.

 

1.9.3B            During the Performance of the Procedure:

 

1.9.3.1B             Adherence to the manufacturer recommendations and/or IFU (instructions for use) or published guidelines for the performance of all non-thermal non-tumescent ablation procedures. 

 

1.9.3.2B             Visualization of proper catheter placement into the target vein with ultrasound-guidance.

 

1.9.4B            NTNT Ablation Procedure-Specific Documentation:

 

1.9.4.1B             Required procedure-specific documentation must include:

 

i.               pharmacologic agents, if used including the volume and concentration;

ii.             use of ultrasound-guidance;

iii.           the starting and ending time of treatment;

iv.           the length of vein treated;

v.             catheter insertion site(s).

 

1.10B        Non-operative Management of Chronic Venous Insufficiency with Ulceration (CEAP Clinical Classification C6)

 

·         wound care including:

o    debridement/bandaging and compression therapy

 

1.10.1B         Prior to Performance of the Procedure:

 

1.10.1.1B          Appropriate supplies as defined by the procedure:

 

i.               wound care, debridement and dressing supplies;

ii.             compression;

iii.           therapeutic support stockings and other compression devices.

 

1.10.1.2B          Appropriate pharmacologic agents.

 

1.10.2B         During the Performance of the Procedure:

 

1.10.2.1B          Standard treatment technique(s) must be used.

 

1.10.3B         Management of Chronic Venous Insufficiency Procedure-Specific Documentation:

 

1.10.3.1B          Post-procedure specific required documentation must include, but is not limited to:

 

i.               dressing utilized;

ii.             medications;

iii.           a description of the ulcer.

STANDARD – Procedure Volumes

1.11B        The procedure volume must be sufficient to maintain proficiency in procedure performance.

 

1.11.1B         The facility must have performed at least 75 superficial venous procedures over the preceding one-year period in at least two of the four categories. There must be a minimum of 25 cases per category to be considered eligible for accreditation:

 

1.11.1.1B          Superficial venous categories:

 

i.               Sclerotherapy

ii.             Ambulatory phlebectomy/powered phlebectomy

iii.           Saphenous vein ablation

·         may include surgical, endovenous thermal, endovenous non-thermal and/or ultrasound-guided chemical ablation

iv.           Non-operative management of chronic venous insufficiency with ulceration (CEAP Clinical classification C6)

·         wound care including:

o    debridement/bandaging and compression therapy