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The IAC Standards and Guidelines Superficial Venous Evaluation and Management |
Click here for a printer-friendly PDF of the Vein
Center Standards |
1.1A The
Medical Director must be a licensed physician (MD or DO) in the state or
jurisdiction of the vein center. The license must be current and unrestricted.
In addition, they must be or have been certified by the American Board of Medical
Specialties, American Osteopathic Association, the Royal College of Physicians
and Surgeons of Canada or Le College des Medicins du Quebec. If board
certification is not current, additional documentation will be required that
must include the following:
· Three
letters of recommendation from physicians who practice in the community and are
familiar with the practice, based on referral and observation.
· If
this Medical Director has hospital privileges, one of the three letters must come
from the Chief of the Service.
(See Guidelines
below for further recommendations.)
1.1.1A Medical Director Required Training and Experience:
At
the time of the initial application for accreditation or at the time of
appointment to the medical staff, he/she must have at least three years of clinical experience post-residency
or fellowship training in the management and treatment of venous disease and
must meet either 1.1.1.1A or 1.1.1.2A:
1.1.1.1A Performed
a minimum of 200 cases over the previous three years in at least two of the
four categories with a minimum of 50 cases per category:
· Sclerotherapy
· Ambulatory phlebectomy/powered phlebectomy
· Saphenous vein ablation
o may include surgical, endovenous thermal, endovenous non-thermal and/or
ultrasound-guided chemical ablation
· Non-operative management of chronic venous
insufficiency with ulceration (CEAP Clinical classification C6)
o wound care including:
s debridement/bandaging
and compression therapy
i. The cases must be documented with a case log.
OR
1.1.1.2A If the Medical Director has successfully completed
an Accreditation Council for Graduate Medical Education (ACGME) approved
residency or fellowship for which venous disease, venous interventional treatment
and venous ultrasound training was included in the core curriculum within three years prior to the
application date.
i. Performed
a minimum of 100 cases over the previous three years in at least two of the
four categories with a minimum of 50 cases per category:
· Sclerotherapy
· Ambulatory phlebectomy/powered phlebectomy
· Saphenous vein ablation
o may include surgical, endovenous thermal, endovenous non-thermal
and/or ultrasound-guided chemical ablation
· Non-operative management of chronic venous
insufficiency with ulceration (CEAP Clinical classification C6)
o wound care including:
s debridement/bandaging
and compression therapy
ii. The
cases must be documented with a case log.
iii. A letter from the program director may be required to confirm completion of the fellowship and case log accuracy.
OR
1.1.1.3A American Board of Vein and Lymphatic Medicine (ABVLM) Certification
1.1.1.4A
Comment:
If a meeting was not solely dedicated to venous disease, venous
interventional treatment and/or venous ultrasound, only the related
hours are to be included in the application for accreditation.
1.1.1.5A Qualifying
and Continuing Medical
Education (CME) Requirement:
i. The Medical Director must obtain a minimum of 30 Category 1 CME credit hours related to venous disease, venous interventional treatment and/or venous ultrasound, in the past three years.
Comment:
If a meeting was not solely dedicated to venous disease, venous
interventional treatment and/or venous ultrasound, only the related
hours are to be included in the application for accreditation.
ii. If the Medical Director has successfully completed an
Accreditation Council for Graduate Medical Education (ACGME) approved residency
or fellowship for venous disease, interventional treatment and ultrasound
training within three years prior to the application date, the CME
requirement will be waived.
iiii. Documentation of CME credits must be kept on file and available for inspection.
1.1.1.6A The
Medical Director must have current Basic Life Support certification, and if moderate/IV sedation is utilized,
Advanced Cardiac Life Support certification is required.
1.1.2A Medical Director Responsibilities:
1.1.2.1A The
Medical Director is responsible for implementing measures to achieve and
maintain compliance with the Standards for all services provided, including
compliance, radiation safety, outcomes, quality control and quality of care and
appropriateness of care provided. The Medical Director responsibilities include
but are not limited to:
i. The Medical Director must
provide oversight of patient safety.
ii. The
Medical Director (or their designee) must review all updates to all
manuals at least annually and as new policies are introduced. This review must
be documented via signature (or initials) and date on the reviewed document or
manual.
iii. The
Medical Director must review quality improvement (QI) documentation that
includes at a minimum those requirements listed in Part C: Quality Improvement.
iv. The
Medical Director may supervise the entire operation of the facility or delegate
specific operations, but is responsible for assuring compliance of medical and
other staff to the Standards outlined in this document.
v. If the Medical Director is
off-site, he/she must have at least a weekly physical presence in the vein
center to participate in regular QI meetings, case study review conferences,
personnel interviews and other facility operations.
1.2A The medical staff member must be a licensed physician
(MD or DO) in the state or jurisdiction of the vein center. The license must be
current and unrestricted. In addition, they must be or have been certified by
the American Board of Medical Specialties, American Osteopathic Association,
the Royal College of Physicians and Surgeons of Canada or Le College des
Medicins du Quebec. If board certification is not current, additional
documentation will be required that must include all of the following:
· Three letters of recommendation from physicians who practice in the community and are familiar with the practice based on referral and observation.
· If this medical staff member has hospital privileges, one of the three letters must come from the Chief of the Service.
(See Guidelines
below for further recommendations.)
1.2.1A Medical Staff Required Training and Experience:
At the time of initial application for accreditation or at the time of appointment to the medical staff, he/she must have clinical experience in the management and treatment of venous disease and must meet either 1.2.1.1A, 1.2.1.2A or 1.2.1.3A:
1.2.1.1A Performed
a minimum of 100 cases over the previous three years in at least one out of the
four categories:
· Sclerotherapy
· Ambulatory phlebectomy/powered phlebectomy
· Saphenous vein ablation
o may include surgical, endovenous thermal, endovenous non-thermal
and/or ultrasound-guided chemical ablation
· Non-operative management of chronic venous
insufficiency with ulceration (CEAP Clinical classification C6)
o wound care including:
s debridement/bandaging
and compression therapy
ii. The
cases must be documented with a case log.
OR
1.2.1.2A If
the medical staff member has successfully completed an Accreditation Council
for Graduate Medical Education (ACGME) approved residency or fellowship for
which venous disease, venous interventional treatment and venous ultrasound
training was included in the core curriculum within three years prior to the application date.
i. Performed
a minimum of 50 cases over the previous three years in at least one out of the
four categories:
· Sclerotherapy
· Ambulatory phlebectomy/powered phlebectomy
· Saphenous vein ablation
o may include surgical, endovenous thermal, endovenous non-thermal
and/or ultrasound-guided chemical ablation
· Non-operative management of chronic venous
insufficiency with ulceration (CEAP Clinical classification C6)
o wound care including:
s debridement/bandaging
and compression therapy
ii. The
cases must be documented with a case log.
iii. A letter from the program director may be required to confirm completion of the fellowship and case log accuracy.
OR
AND
1.2.1.5A Qualifying and Continuing Medical Education (CME) Requirements:
i. The medical staff must obtain a minimum of 30 Category I CME credit hours related to venous disease, venous interventional treatment and/or venous ultrasound, in the past three years.
Comment:
If a meeting was not solely dedicated to venous disease, venous
interventional treatment and/or venous ultrasound, only the related
hours are to be included in the application for accreditation.
ii. If the medical staff member has successfully completed an Accreditation Council for Graduate Medical Education (ACGME) approved residency or fellowship for venous disease, interventional treatment and ultrasound training within three years prior to the application date, the CME requirement will be waived.
AND
1.2.1.6A All
medical staff must have current Basic Life Support certification, and if moderate/ IV sedation is utilized,
Advanced Cardiac Life Support certification is required.
1.2.2A Provisional Medical Staff:
1.2.2.1A The
qualified Medical Director
may appoint a qualified staff member(s) as provisional staff who meets all of
the above criteria with the exception of the required procedure performance volumes. The
Medical Director will be responsible for review of the provisional staff member
including biannual review of case log including outcomes. The provisional
medical staff member must attain full medical staff status prior to reaccreditation.
1.2.3A Medical Staff Responsibilities:
1.2.3.1A The
medical staff is responsible for performing venous evaluation, management and
treatment. Responsibilities may include, but are not limited to:
i. The
medical staff must comply with all of the facility’s policies,
procedures, and/or protocols and to the Standards outlined in this document.
ii. The
medical staff must be responsible for equipment training and inspection to
ensure safe operating conditions as specified by the manufacturer’s
guidelines and the Medical Director.
iii. The
medical staff must participate in the facility’s comprehensive Quality
Improvement (QI) program.
All non-physician personnel within
the facility must have a specific job description on file and must be evaluated
annually for performance and competency.
1.3A The Advanced Practice
Provider works under the
direction of the Medical Director or a medical staff member who is listed in
the application. The Advanced Practice Provider must be a licensed
professional who possesses knowledge in the treatment of venous disorders and
meets the required certification and experience qualifications as outlined in
this document and the required certification and experience qualifications
determined by local, state and/or federal regulations within the scope of
practice of an Advanced Practice Provider.
(See Guidelines
below for further recommendations.)
1.3.1A Advanced Practice
Provider Required
Training and Experience:
1.3.1.1A The
APP
must meet one of the following criteria for required certification:
i. Physician
Assistant (PA)
ii. Nurse
Practitioner (NP)
1.3.1.2A
The APP must obtain a minimum of 30 Category I CME credit hours related
to venous disease, venous interventional treatment and venous
ultrasound, in the prior three years.
Comment: If a meeting was not solely dedicated to venous disease,
venous interventional treatment and/or venous ultrasound, only the
related hours are to be included in the application for accreditation.
1.3.1.3A The
APP must have current Basic Life Support certification, and if
performing procedures with moderate/IV sedation, Advanced Cardiac Life
Support certification is required (even if another provider
participating in moderate/IV sedation cases already possesses such
certification).
Comment: Additional credentials may be required as they become available.
1.3.1.4A APPs may perform the following superficial vein skills under the personal supervision1 of a qualified medical staff member:
i. patient evaluation and management;
ii. visual sclerotherapy;
iii. ambulatory phlebectomy;
iv. saphenous vein ablation.
1.3.1.5A APP
may perform certain skills with direct or general supervision within
the vein center after qualifying in at least one of three pathways
summarized below or as shown in Table 1.3.1.5A on page 10.
The APP must fulfill one of the following qualifying pathways for each
skill, based on their skill specific prior experience, in order to be
considered credentialed to practice that skill with less than personal
supervision:
i. New providers without prior experience:
• APP does not have prior experience in superficial vein disease/procedures.
OR
ii. Provider with experience in a facility other than the applicant facility:
• APP must have a case log of their prior experience
that includes outcomes and level of supervision. An attestation of
experience and level of supervision by a prior supervising physician
may also satisfy this requirement.
OR
iii. Provider with experience in the applicant facility:
• APP has experience and training in the treatment of
superficial vein disease/procedures under supervision of the current
Medical Director, or one of the medical staff.
• APP must have a case log of their prior experience
which include outcomes and level of supervision and an attestation of
the Medical Director of their prior experience.
| Table 1.3.1.5A |
|||
| Skill |
New providers without prior skill specific experience |
Provider with skill specific experience in a facility other than the applicant facility |
Provider with skill specific experience in the applicant facility |
| Evaluation and Management of Venous Disease |
A
minimum of 100* patients evaluated over the previous three years under
personal supervision1 of a qualified medical staff member. At least 30*
cases must include personal observation of that patient’s diagnostic
venous ultrasound examination(s). |
A minimum of 25* patients evaluated over the previous three years under personal supervision1 of a qualified medical staff member. | A
minimum of 25* patients evaluated over the previous three years under
personal1, direct2, or general supervision3 of a qualified medical
staff member. |
| Visual Sclerotherapy |
A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member. | A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member. |
A
minimum of 10* cases over the previous three years under personal1,
direct2, or general supervision3 of a qualified medical staff member. |
| Ambulatory Phlebectomy |
A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member. |
A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member. |
A minimum of 10* cases over the previous three years under personal1 or direct supervision2 of a qualified medical staff member. |
| Ultrasound-guided Foam Sclerotherapy |
A minimum of 150* cases over the previous three years under personal supervision1 of a qualified medical staff member. OR A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member if the APP holds an appropriate credential in vascular testing (RVT, RVS, RT(VS), RPhS). |
A minimum of 50* cases over the previous three years under personal supervision of a qualified medical staff member. |
A minimum of 50* cases over the previous three years under personal1 supervision2 of a qualified medical staff member. OR A minimum of 50* cases over the previous three years under direct supervision2 if the APP holds an appropriate credential in vascular testing (RVT, RVS, RT(VS), RPhs). OR A minimum of 50*cases over the previous three years under direct supervision2 if performed with a credentialed vascular sonographer (RVT, RVS, RT(VS), RPhs). |
| Wound Care |
A minimum of 20* cases over the previous three years under personal supervision1 of a qualified medical staff member. |
A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member. |
A
minimum of 10* cases over the previous three years under personal1,
direct2, or general supervision3 of a qualified medical staff member. |
| (*) Each
case performed in the current or prior vein center that is being
presented to fulfill a case volume requirement should be kept in a case
log which includes case, outcome, complications and level of
supervision. The log must be available for review upon request. |
|||
1.3.1.6A Ongoing
skill specific supervision requirements (once APP has been credentialed
in a specific skill(s) as described above in 1.3.1.5A):
i. Evaluation and management of venous disease must
be performed under personal1, direct2 or general supervision3 of a
qualified medical staff member.
ii. Visual sclerotherapy must be performed under
personal1, direct2 or general supervision3 of a qualified medical staff
member.
iii. Ambulatory phlebectomy must be performed under
personal1 or direct supervision2 of a qualified medical staff member.
iv. Ultrasound-guided foam sclerotherapy must be
performed under personal supervision1 of a qualified medical staff
member.
OR
Cases may be performed under direct supervision2 if the APP holds an
appropriate credential in vascular testing (RVT, RVS, RT(VS), RPhS).
OR
Cases may be performed under direct supervision2 if performed with a
credentialed vascular sonographer (RVT, RVS, RT(VS), RPhS).
v. Saphenous
vein ablation must be performed under personal supervision1 of a
qualified medical staff member.
vi. Wound
care must be performed under personal1, direct2 or general supervision3
of a qualified medical staff member.
1.3.1.7A In addition to fulfilling the necessary requirements above, a case log must be maintained that documents skills performed, including the level of supervision, clinical outcomes and complications in each case. The case log must be reviewed by the Medical Director during the bi-annual QI meeting.
1.3.2.1A The
qualified Medical Director may appoint a qualified APP as provisional
staff who meets all of the above criteria with the exception of the
required procedure performance volumes and CME. All procedures for each
applicable skill must be performed under the personal supervision1 of a
qualified medical staff member until a qualifying pathway and CME
requirements are met. The Medical Director will be responsible for
review of the provisional APP including bi-annual review of the case
log including outcomes at the bi-annual QI meeting. The provisional APP
must attain full APP status prior to reaccreditation.
1.4A A nurse works under the direction of the Medical
Director or a medical staff member who is listed in the application. The nurse must be a licensed
registered nurse (RN) or licensed practical/vocational nurse (LPN/LVN) who
possesses knowledge in the treatment of venous disorders and meets the required
certification and experience qualifications as outlined in this document.
(See Guidelines
below for further recommendations.)
1.4.1A Nursing Staff Required Training and Experience:
1.4.1.1A If
performing visual sclerotherapy, a minimum of 50 cases must be documented over
the previous three years.
1.4.1.2A If performing wound care,
superficial debridement, bandaging and compression therapy, a minimum of 20 cases
must be documented over the previous three years.
1.4.1.3A Attestation or a case log
that documents evidence of supervised training in the above procedures must be
available for review upon request.
1.4.1.4A All
nursing staff must maintain current Basic Life Support certification.
1.4.2A Provisional Nursing Staff:
1.4.2.1A The qualified Medical Director may appoint a qualified nurse as provisional staff who meets all of the above criteria with the exception of the required procedure performance volumes. The Medical Director will be responsible for review of the provisional nurse including biannual review of case log including outcomes. The provisional nursing staff member must attain full nursing status prior to reaccreditation.
Comment: If a meeting was not solely dedicated to venous disease, venous interventional treatment and/or venous ultrasound, only the related hours are to be included in the application for accreditation.
1.4.3A Nursing Staff
Qualifying and
Continuing Education (CE/CME) Requirements:
1.4.3.1A The
nurse must obtain a minimum of 30 contact hours/Category 1 CME with at least 15 CE/CME related to venous disease
in the past three years. All CE hours must be approved.
(i.e., AMA Category I, SVU, SDMS, American Nurses Credentialing Center
(ANCC-Category I).
1.4.3.2A The
CE/CME requirement will be waived if, in the previous three years the nurse
has:
i. completed
formal training;
ii. acquired
an appropriate vascular credential (Registered Vascular Technologist (RVT),
Registered Vascular Specialist (RVS), Registered Technologist Vascular
Sonography [RT(VS)], Registered Phlebology Sonographer (RPhS);
iii. been
employed in the facility less than one year.
1.4.3.3A Documentation
of CME credits must be kept on file and available for inspection.
1.5A The ultrasound technologist/sonographer is a
credentialed professional who possesses advanced ultrasound knowledge about the
diagnosis of acute and chronic venous disorders and works under the direction
of the Medical Director. A technologist must meet the required training and
experience qualifications as outlined in this document.
1.5.1A Ultrasound Technologist Required Training and
Experience:
1.5.1.1A Must have an appropriate level of training and
experience and must have a valid appropriate credential in vascular testing:
i. Registered Vascular Technologist (RVT)
ii. Registered Vascular Specialist (RVS)
iii. Registered Technologist Vascular Sonography
[RT(VS)]
iv. Registered Phlebology Sonographer (RPhS)
1.5.1.2A Each
technologist must have performed a minimum of 100 diagnostic peripheral venous
duplex examinations (half of which must be complete examinations for reflux) in
the previous three years.
1.5.2A Ultrasound Technologist Responsibilities:
1.5.2.1A Ultrasound
technologist responsibilities may include, but are not limited to:
i. performance
and documentation of clinical examinations;
ii. demonstration
of appropriate sterile technique knowledge and skills for use when assisting a
physician with a sterile procedure.
1.5.3A Ultrasound Technologist Continuing Medical Education
(CME) Requirements:
1.5.3.1A The
technologist must obtain at least 15 CME credit hours every three years
relevant to venous disease, venous interventional treatment and/or peripheral
venous ultrasound. All hours must be approved CME (i.e., AMA Category I, SVU,
SDMS).
1.5.3.2A Documentation
of CME credits must be kept on file and available for inspection.
1.5.3.3A The CME requirement will be waived if:
i. the technologist acquired an appropriate vascular
credential within the previous three-year period.
1.6A The facility must ensure that adequately supervised
ancillary personnel are available to perform safe and effective patient care
appropriate for the level of service, as designated by the Medical Director.
1.6.1A Ancillary Personnel Required Training and Experience:
1.6.1.1A Ancillary
personnel may consist of, but are not limited to:
i. technical/medical
assistants;
ii. clerical
and administrative assistants;
iii. computer
support staff;
iv. equipment
support staff (i.e., biomedical).
1.7A There must be a written protocol for:
1.7.1A Each procedure performed in the facility with
indications, contraindications, pretreatment evaluation and reporting outcomes.
1.7.2A Adherence to National Patient Safety Goals must be documented.
1.7.3A Treatment and or referral of patients with superficial
venous thrombosis evaluation and management.
1.7.4A Treatment and/or referral of patients with DVT,
arterial disease and complications of treatments provided in the vein center.
1.7.5A Treatment
of allergic reactions or toxicity that results from the use of any administered
medications during the procedure and/or during recovery ensuring patient safety,
including supplies to be used, staff to be present and medications for
administration (refer to Standards 2.2.4A, 2.2.5A and 2.2.6A).
1.7.6A The referral of patients who present with wounds that
cannot be managed in the vein center.
1.7.7A Routine supply inventory of disposable supplies (e.g.,
catheters, LASER fibers, guide wires, sheaths, needles, syringes, contrast
agent, medications) based on facility volume to assure that these supplies are
readily available during a procedure.
1.7.8A Proper disposal of used or expired supplies.
1.8A There must be written
guidelines for:
1.8.1A Intravenous access and administration of fluids and
medications, if used.
1.8.2A Monitoring
patients undergoing procedures using mild sedation (anxiolysis), if used.
1.8.3A Use
of moderate sedation or greater, and must be in compliance with state
regulations and American
Society of Anesthesiology (ASA) Guidelines
1.8.3.1A There
must be at least one person in the procedure room with Advanced Cardiac Life
Support (ACLS) certification.
Section 1A: Personnel and Supervision
Guidelines
1.1A and
1.2A Participation
in a venous registry is encouraged, but is not mandatory.
1.1.1.3Aii and 1.2.1.3Aii Comment:
If a meeting was not solely dedicated to venous disease, venous interventional
treatment and/or venous ultrasound, only the related hours are to be included
in the application for accreditation.
1.3A Advanced Practice Provider
responsibilities may include, but are not limited to:
· obtaining
a record of anatomical, pathological and/or physiologic data (CEAP
classification);
· participation
in vein center safety practices including, but not limited to, safe use of
equipment and review of patient outcomes and complications;
· knowledge
and maintenance of sterile technique;
· knowledge
regarding compression techniques, including stockings and bandaging;
· wound
care, fitting patients for elastic compression, and inelastic bandaging;
· visual
sclerotherapy;
· medication
administration;
· post-procedure
discharge instructions;
· phone
triage;
· patient
education;
· assisting
a staff physician with image-guided sclerotherapy, ambulatory phlebectomy,
endovenous ablation and other invasive procedures;
· performing
other procedures and duties, as assigned.
1.4A Nursing
staff responsibilities may include, but are not limited to:
· reviewing
and/or recording pertinent patient history and supporting clinical data;
· obtaining
a record of anatomical, pathological and/or physiologic data (CEAP classification);
· participation
in vein center safety practices including but not limited to safe use of
equipment and review of patient outcomes and complications;
· knowledge
and maintenance of sterile technique;
· visual
sclerotherapy;
· medication
administration;
· wound
care;
· fitting
patients for elastic compression;
· application
of inelastic compression and patient education;
· post-procedure
discharge instructions;
· phone
triage;
· patient
education;
· assisting
a staff physician with image-guided sclerotherapy, ambulatory phlebectomy,
endovenous ablation and other invasive procedures;
· other
procedures and duties, as assigned