St. John’s Hospital Department of Radiology Vascular & Interventional Radiology Delineation of Clinical Privileges and Procedures Basic Education: MD or DO Basic Requirement: Possession of Core Privileges in the Department of Radiology. Training: Successful completion of an ACGME-accredited residency in diagnostic radiology, followed by either: A) Successful completion of an ACGME-accredited fellowship training program in vascular and interventional radiology. OR B) Adequate post residency training and clinical experience in Interventional Radiology procedures approved by the Department of Radiology Chairperson. OR C) Adequate training meeting criteria for the American Board of Radiology Certificate of Added Qualification in Interventional Radiology. Experience: This can be demonstrated in one of the following ways: An applicant who has just completed a residency or fellowship shall provide his/her residency or fellowship log. OR An applicant who is not applying directly out of a residency or fellowship shall provide a quality profile from hospital(s) where he/she currently has privileges showing his or her clinical activity for the past 12 months, including numbers of procedures performed, morbidity, mortality rates and other complications. OR If a quality profile is not available from the hospital(s) where the applicant currently has privileges, documentation of the applicant's hospital-based clinical activity for the past 12 months. OR An applicant with clinical experience that satisfies requirements for the American Board of Radiology Certificate of Added Qualification in Interventional Radiology. Certification: Within five years of completion of an approved residency, certification in diagnostic radiology by the American Board of Radiology or the American Osteopathic Board of Radiology.

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Specialty Description: Evaluation and management of patients potentially requiring diagnostic vascular imaging guided interventional procedures. Procedures – these are in addition to core radiology image guided procedures • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Adrenal Venous Sampling Angioplasty/Vascular Stent Carbon Dioxide Angiography Catheter Directed Thrombolysis Central Venous Access * Chemoembolization Intra-arterial Chemotherapy Infusion Diagnostic Ateriography * Dialysis Access Interventions including Thrombectomy, Angioplasty, and Stents Direct Percutaneous Jejunostomy Embolotherapy Inferior Vena Cava Filter Insertion Intravascular Foreign Body Removal Intravascular Ultrasound Mechanical Thrombectomy Neuroangiography * Parathyroid Venous Sampling Percutaneous Abscess and Fluid Drainage Procedures * Transvenous Biopsy Percutaneous Biliary Drainage * Percutaneous Cecostomy Percutaneous Cholecystostomy * Percutaneous Drainage for Diagnosis and Treatment of Infections and Other Fluid Collections * Percutaneous Gastrojejunostomy Percutaneous Gastrostomy Percutaneous Image-guided Biopsy * Percutaneous Ablation of Neoplasms and Cysts (including RF Ablation, Cryotherapy) Percutaneous Nephrostomy * Percutaneous Stone Extraction Percutaneous Transhepatic Cholangiogram (PTC) * Percutaneous Vertebroplasty Peripheral and Visceral Arteriography * Pulmonary Arteriography Paracentesis * Thoracentesis * Transjugular Intrahepatic Portosystemic Shunt (TIPS) * Transcatheter Infusion Therapy Ureteral Stenting Uterine Artery Embolization (UAE) Vascular Access Devices and Catheters Insertion (including Tunneled Catheters, Subcutaneous Implanted Ports, PICC Lines, and Central Lines Vascular Stenting Venography * 2

*These procedures are considered Core Radiology privileges in Image Guided Procedures.

DATE___________________

________________________________________ Signature of Applicant

DATE___________________

________________________________________ Approval of Department Chairman

Approved by Department: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

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St. John’s Hospital Criteria for Privileges in CAROTID STENTING I. Definition: Carotid artery stenting is a procedure in which your physician/surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque. http://www.vascularweb.org/_CONTRIBUTION_PAGES/Patient_Information/NorthPoint/Carotid_Stenting.html Note: Physicians representing multiple subspecialties with diverse backgrounds and varying levels of expertise will seek training in carotid intervention. Training and credentialing requirements must recognize this diversity, acknowledge the relevant background experience of individuals from each specialty, and be tailored to the particular needs of the individual seeking training. This approach will lead to comparable and acceptable outcomes for patients 1 treated by physicians from different backgrounds. II. Eligibility: Core privileges in cardiology, interventional cardiology, neurosurgery, radiology, surgery, vascular & 1 interventional radiology, or vascular surgery; FIRST PATHWAY Training in the performance of carotid stenting as part of an accredited residency or fellowship training program in conjunction with peripheral angioplasty training that is inclusive of the carotid territory. SECOND (PRACTICE) PATHWAY Training in the performance of carotid stenting in a supervised clinical practice environment with a mentor/supervisor scrubbed alongside. Throughout the entire process the trainee/primary operator, is personally directing the guidewires, placing the sheath, positioning and retrieving the distal protection device and balloons and deploying the stent. AND Current privileges in vascular medicine and catheter-based peripheral vascular interventions and actively performing 1, 2 a variety of endovascular procedures; AND Demonstrate proficiency in the cognitive elements including the fund of knowledge regarding cerebrovascular 1 disease, its natural history, pathophysiology, diagnostic methods, and treatment alternatives; AND Documentation of current clinical competence by meeting the technical requirements for performance of carotid stenting with a minimum number of 30 diagnostic cervico-cerebral angiograms (> half as primary operator) and 25 carotid stent procedures (> half as primary operator). Angiograms and stenting procedures may be performed in the same setting provided that one perform 15 angiograms as primary operator BEFORE performing the first stent as 1 primary operator.

AND Demonstrate proficiency in the clinical elements, including the ability to manage inpatients and outpatient care.

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III. Required Documentation: An evaluation from the director/proctor of the applicant’s accredited residency OR fellowship training program that included peripheral angioplasty and carotid stenting; OR An evaluation from the department chair at another hospital where the applicant is/was granted privileges to perform carotid stenting OR from another professional colleague who has direct knowledge of the applicant’s competence to perform carotid stenting;

AND Reevaluation on regular long-term basis, with multidisciplinary peer review.

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Note: If privileges in carotid stenting are granted, the exercise of the privileges shall be proctored as outlined in the hospital’s provisional appointment policy. IV. Reappointment: Demonstration of continuing competence in the performance of carotid stenting reflected in the applicant’s quality profile. AND Evidence of continuing medical education related to carotid intervention.

_____________________________________ Applicant’s Signature

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_____________________________________ Department Chair’s Signature

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These are the minimum volume requirements for a physician to establish proficiency in performing this procedure that were recommended by the Journal of the American College of Cardiology, Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine and Biology (SVMB), and the Society for Vascular Surgery (SVS), “Clinical Competence Statement on Carotid Stenting: Training and Credentialing for Carotid Stenting-Multispecialty Consensus Recommendations” http://content.onlinejacc.org/cgi/content/full/45/1/165 2

These are the minimum volume requirements for a physician to establish proficiency in performing vascular medicine and catheter-based peripheral vascular interventions that were recommended by the American College of Cardiology, the American Heart Association, the American College of Physicians Task Force on Clinical Competence (ACC/ACP/SCAI/SVMB/SVS Writing Committee to Develop a Clinical Competence Statement on Peripheral Vascular Disease), “ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions” http://www.scai.org/PDF/Carotid%20competency%20document%20(updated%20file).pdf

Approved by Department Chair: 10/02/12 Approved by Credentials Committee: 10/26/12 Approved by Medical Executive Committee: 11/03/2012 Approved by Board of Directors: 12/5/2012

St. John’s Hospital Criteria for Privileges in KYPHOPLASTY I. Definition: A minimally invasive procedure designed to stop pain caused by bone fracture, to stabilize the bone, and to restore some or all of the lost body height due to the compression fracture. A small incision is made in the back through which a narrow tube is placed. Using fluoroscopy to guide it to the correct position, a path is created through the back into the fractured area of the involved vertebrae. Using x-ray images, a special balloon (KyphX Inflatable Bone Tamp, manufactured by Kyphon Inc.) is inserted into a tube and into the vertebrae, then gently inflated, returning the pieces to a more normal position. The balloon is removed and a specially designed instrument under low pressure is used to fill the cavity with a cement-like material called polyethylmethacrylate (PMMA). After being injected, the pasty material hardens and stabilizes the bone. http://www.spine-health.com/research/kyph/kyph02.html II. Eligibility: Core privileges in neurological surgery, neuroradiology, orthopaedic surgery, spine surgery or radiology or vascular radiology. AND Training in the performance of kyphoplasty as part of a residency training program; OR Successful completion of an appropriate training program in the performance of kyphoplasty; AND Demonstration of current clinical competence by performance of a minimum of 10 balloon kyphoplasty procedures 1 during the last 12 months. III. Required Documentation: An evaluation from the director of the applicant's residency training program that included kyphoplasty OR from the director of another appropriate training program in kyphoplasty; AND An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform kyphoplasty OR from another professional colleague who has direct knowledge of the applicant's competence to perform kyphoplasty; AND Documentation of CMEs related to knowledge and technical skill in kyphoplasty. Note: If privileges in kyphoplasty are granted, the exercise of the initial privileges shall be as outlined in the hospital’s FPPE appointment policy. IV. Reappointment: Demonstration of continuing competence by performance of at least 10 balloon kyphoplasty 1 procedures during the past 24 months; AND Evidence of continuing medical education related to kyphoplasty procedures.

Date___________________

Signature of Applicant_____________________________________________

Date___________________

Signature of Department Chair______________________________________

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These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by physicians who are qualified and experienced in this procedure.

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in ENDOVASCULAR AORTIC STENT GRAFT PLACEMENT

I. Definition:

An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. The stent graft seals tightly with the artery above and below the aneurysm. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms. The procedure requires a small incision in an artery or vein, through which the vascular surgeon inserts catheters, which carry the devices through the blood vessels to the location of the aneurysm. http://www.vascularweb.org/_CONTRIBUTION_PAGES/Patient_Information

II. Eligibility: Core privileges in cardiology, cardiovascular surgery, endovascular surgical neuroradiology, interventional cardiology, vascular and interventional radiology or vascular surgery. AND Training in the performance of endovascular grafting procedures as part of a residency or fellowship training program. AND Demonstration of current clinical competence by performance of a minimum of 10 aortic aneurysm endografts with 5 as the primary operator.1 Note: Beginning in 2004 each vascular fellow will be required to perform a minimum of 100 diagnostic and 50 therapeutic endovascular procedures plus 5 to 10 aortic aneurysm endovascular grafting procedures.1 III. Required Documentation An evaluation from the director of the applicant’s residency training program that included endovascular grafting procedures OR from the director of another appropriate training program in endovascular grafting procedures. AND An evaluation from the department chair at another hospital where the applicant is/was granted privileges to perform endovascular grafting procedures OR from another professional colleague who has direct knowledge of the applicant’s competence to perform endovascular grafting procedures. IV. Reappointment: Demonstration of continuing competence by performance of at least 25 endovascular grafting procedures during the past 24 months.1 AND Evidence of continuing medical education related to the cognitive and technical skills of abdominal aortic aneurysm repair.

Date_________________

Signature of Applicant____________________________________________________

Date_________________

Signature of Department Chair_____________________________________________

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These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by Creager MA. Goldstone J, Hirshfeld JW, Kazmers A, Kent CJ, Lorell BH, Olin JW, Pauly RR, Rosenfield K, Roubin GS, Sicard GA, and White CJ, "ACC/ACP/SCAI/SVMB/SVS "Clinical Competence Statement on Vascular Medicine and CatheterBased Peripheral Vascular Interventions: A Report of the American College of Cardiology/American Heart Association/American College of Physicians Task Force." http://www.acc.org/qualityandscience/clinical/competence/pvd/index.pdf

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in ENTERAL STENTING I. Definition: Enteral stenting is the process of relieving obstructions in the digestive tract which cause discomfort and digestive problems. These can be secondary to cancers in the stomach, small intestine, bile duct, pancreas and colon. A stent is an expandable mesh or wire tube inserted into the body through an endoscope and placed in the narrow opening of the obstruction and is expanded to relieve the obstruction II. Eligibility: Core privileges in gastroenterology, general surgery, interventional radiology or thoracic surgery; Demonstrate successful completion of an accredited fellowship training program that included endoscopic enteral stent (esophageal, gastric/duodenal, and colon) deployment; AND Demonstrate a procedural case log of a minimum 10 successful enteral stent insertions in a supervised setting.

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III. Required Documentation: An evaluation from the director of the applicant's training program that included 10 successful enteral stent insertions; AND An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform enteral stent insertions OR from another professional colleague who has direct knowledge of the applicant's competence to perform enteral stent insertions. Note: If privileges in enteral stent insertions are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence in performance of enteral stent insertions as reflected in the applicant's quality profile; AND Evidence of continuing medical education related to enteral stent insertions and new technology.

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_____________________________________ Applicant’s Signature

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_____________________________________ Department Chair’s Signature

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These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by directors of an American Society for Gastrointestinal Endoscopy (ASGE) Advanced Endoscopy Fellowship training program. 2

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). www.sages.org

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in INTRAVASCULAR BRACHYTHERAPY I. Definition: Brachytherapy is a method of treatment in which sealed radioactive sources are used to deliver radiation by interstitial, intracavitary, surface, or more recently, by intravascular brachytherapy (IVBT) application…At the present time; various methods exist to deliver the ionizing radiation from the brachytherapy source to peripheral or cardiac vessels. Broadly speaking, intravascular radiation delivery ensues from either catheter-based systems deploying either gamma or beta emitters or the implantation of radioactive stents…This procedure is usually carried out in the cardiac catheterization laboratory or interventional radiology setting using a team approach. http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/MedicalPhysics/ACRTechnicalStandardf orthePerformanceofBrachytherapyPhysicsIntravascularApplicationsUsingCatheter-BasedSystem(IVBT)Doc10.aspx Minimally, the team responsible for the intravascular radiation delivery consists of a radiation oncologist, an interventional cardiologist or interventional radiologist, and a medical physicist…The interventional cardiologist or interventional radiologist, a radiation oncologist, and a medical physicist should all be physically present during the treatment. The role of the interventional cardiologist or interventional radiologist is to manage and monitor the patient; the radiation oncologist treats the patient; and the medical physicist is in charge of radiation safety, dosimetry, and documentation. The ACR recommends that the Qualified Medical Physicist be certified in the appropriate subfield(s) by the American Board of Radiology (ABR). The appropriate subfield(s) of medical physics for this standard are Therapeutic 1 Radiological Physics and Radiological Physics. The US Nuclear Regulatory Commission (NRC), or other Agreement States enforce hospital licensing and safety 2 requirements of radioactive sources. II. Eligibility: Core privileges in interventional cardiology, medical physicist, radiation oncology or vascular & interventional radiology. Intravascular brachytherapy treatment is a core privilege for radiation oncology.

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AND If residency training in radiation oncology did not include (intravascular) brachytherapy, then specific training in (IVBT) 4 as mandated by the FDA should be obtained prior to performing any vascular brachytherapy procedures. III. Required Documentation: An evaluation from the director of the applicant’s fellowship training program that included intravascular brachytherapy OR from the director of another appropriate program that included intravascular brachytherapy. AND An evaluation from the department chair at another hospital where the applicant is/was granted privileges to perform intravascular brachytherapy OR from another professional colleague who has direct knowledge of the applicant’s competence to perform intravascular brachytherapy. Note: If privileges in intravascular brachytherapy are granted, the exercise of the privileges shall be proctored as outlined in the hospital’s provisional appointment policy. IV. Reappointment: Demonstration of continuing competence in performance of intravascular brachytherapy as reflected in the applicant’s quality profile; AND Evidence of continuing medical education related to intravascular brachytherapy.

_____________________________________ Applicant’s Signature

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_____________________________________ Department Chair’s Signature

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The guidelines on Intravascular Brachytherapy were recommended by the American College of Radiology, “ACR Technical Standard for the Performance of Brachytherapy Physics: Intravascular Applications Using Catheter-Based System (IVBT)”. http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/ivbt.aspx 2

Nuclear Regulatory Commission: SECY-00-0118 – Final Rules – 10 CFR Part 35, “Medical Use of Byproduct Material” and 10 CFR Part 20, “Standards for Protection Against Radiation: http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2000/secy2000-0118/20000118scy.html 3

These are the minimum requirements suggested for a radiation oncologist to establish proficiency in performing this procedure recommended by ACGME-accredited radiation oncology training programs. http://www.acgme.org/acWebsite/downloads/RRC_progReq/430_radiation_oncology_07012007.pdf 4

The information on Coronary Vascular Brachytherapy, including minimum physician requirements, was recommended by the American College of Radiology, “ACR Practice Guideline for the Performance of Coronary Vascular Brachytherapy (CVBT). http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/RadiationOncology/ACRPra cticeGuidelineforthePerformance ofCoronaryVascularBrachytherap0y(CVBT)Doc5.aspx

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 12/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in TM MICRODELIVERY STENT SYSTEM NEUROFORM I. Definition: The Neuroform™ Microdelivery Stent System is designed to prevent the rupture of an aneurysm in the brain (an intracranial aneurysm). An aneurysm is formed by an abnormally weakened area in an artery wall. As time passes, the weak area stretches to form a balloon-like bulge in the artery wall. Without treatment, the weakened area 1 could rupture and hemorrhage. The delivery system carries and delivers the stent to the aneurysm site. The stent is placed across the neck of the aneurysm. When the stent expands in place to conform to the inside of the artery wall, the delivery catheter is withdrawn. The physician then passes another catheter through one of the small openings in the mesh of the stent and slides small metal coils (called embolic coils) through this second catheter into the aneurysm. The coils block blood from going into the aneurysm to help prevent the aneurysm from rupturing, and the stent keeps the coils from falling out of the aneurysm sac. The Neuroform™ Microdelivery Stent System is for use with embolic coils for the treatment of wide neck intracranial aneurysms that cannot be treated by placing a metal clip around the aneurysm neck (surgical clipping). http://www.fda.gov/cdrh/mda/docs/h020002.html II. Eligibility: Core privileges in endovascular neuroradiology, interventional neuroradiology, interventional radiology or neurosurgery;

AND Training in the treatment of intracranial aneurysms as part of a residency or fellowship training program;

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AND Completion of a NeuroformTM Microdelivery Stent System Physician Training Program which includes a minimum of 2 proctored cases by an approved Boston Scientific Proctor;2 III. Required Documentation: An evaluation of the applicant’s proctored cases from the Boston Scientific Physician Proctor; AND TM

An evaluation from the director of the applicant’s Neuroform Microdelivery Stent System Physician Training Program and a copy of the applicant’s Certificate of Completion; TM

Note: If privileges in Neuroform Microdelivery Stent System are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence by performance of Neuroform System as reflected in the applicant’s quality profile during the past 24 months;

TM

Microdelivery Stent

AND Evidence of continuing medical education related to the treatment of aneurysms. _____________________________________ Applicant’s Signature

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_____________________________________ Department Chair’s Signature

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The FDA has outlined specific indications for use in the “Summary of Safety and Probable Benefit” http://www.fda.gov/cdrh/pdf2/H020002.pdf. Further information can be obtained at http://www.fda.gov/cdrh/mda/docs/H020002.html. 2

These are the minimum requirements for a physician to establish proficiency in performing this procedure that are required by the device manufacturer, Boston Scientific Corporation’s TM “Neuroform Microdelivery Stent System Physician Training Program” http://www.bostonscientific.com/neuro.

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in PERCUTANEOUS TRANSLUMINAL PERIPHERAL ANGIOPLASTY (PTPA or PTA) I. Definition: Minimally invasive procedure to insert an inflated, small balloon inside a narrowed blood vessel. The balloon helps widen the blood vessel and restore normal blood flow. Stents may be inserted in order to support the artery wall and keep the vessel open. The procedure is usually done through a small incision or puncture in the skin. The physician inserts a catheter, and guides the catheter through the blood vessels to the blocked area. The tip of the catheter carries the angioplasty balloon or stent. Society for Vascular Surgery http://www.vascularweb.org/_CONTRIBUTION_PAGES/Patient_Information/NorthPoint II. Eligibility: Core privileges in cardiology, interventional cardiology, interventional radiology or vascular surgery; AND Training in the performance of percutaneous transluminal peripheral angioplasty (PTPA) as part of a residency or fellowship training program; OR Successful completion of an appropriate training program in the performance of percutaneous transluminal peripheral angioplasty (PTPA); AND Demonstration of current clinical competence by performance of a minimum of 100 peripheral arteriography procedures and 50 peripheral/renal PTPA procedures with 25 as primary operator and 10 cases of peripheral 1 thrombolysis cases with 5 as primary operator. III. Required Documentation: An evaluation from the director of the applicant's residency training program that included percutaneous transluminal peripheral angioplasty (PTPA) OR from the director of another appropriate training program in percutaneous transluminal peripheral angioplasty (PTPA); AND An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform percutaneous transluminal peripheral angioplasty (PTPA) OR from another professional colleague who has direct knowledge of the applicant's competence to perform percutaneous transluminal peripheral angioplasty (PTPA); AND Documentation of 50 CME category 1 credits in diagnostic peripheral angiography and percutaneous peripheral 1 vascular interventional techniques. Note: If privileges in percutaneous transluminal peripheral angioplasty (PTPA) are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence in performance of percutaneous transluminal peripheral angioplasty (PTPA) as reflected in the applicant's quality profile; AND Evidence of continuing medical education related to percutaneous transluminal peripheral angioplasty (PTPA) privileges.

Date_________________________ Applicant’s Signature______________________________________________

Date__________________________ Department Chair’s Signature_______________________________________

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These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by the Society of Interventional Radiology (SIR), the American College of Cardiology (ACC), American College of Radiology (ACR), and American Heart Association (AHA). "Credentialing Statements: Training Standards for Physicians Performing Peripheral Angioplasty and other Percutaneous Peripheral Vascular Interventions." http://www.sirweb.org/clinical/cpg/S359.pdf

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in SILVERHAWK™ PERIPHERAL PLAQUE EXCISION SYSTEM I. Definition: The SilverHawk™ Plaque Excision System is an FDA-cleared device for the treatment of de novo and restenotic lesions in the peripheral arteries. laque excision is a minimally invasive procedure performed through a tiny puncture site in the leg or arm. The SilverHawk System uses a tiny rotating blade to shave away plaque from inside the artery. As it is excised, the plaque collects in the tip of the device and then is removed from the patient. http://www.foxhollowtech.com/wt/page/plaque_excision The system is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in 1 coronary or carotid vasculature. II. Eligibility: Core privileges in interventional cardiology, interventional radiology or vascular surgery;

AND Training in the performance of peripheral catheter-based interventions as part of a residency or fellowship training 2 program;

AND Participation in a SilverHawk™ Peripheral Plaque Excision System preceptorship course under the direction of an 3 experienced physician interventionalist with the opportunity for hands on experience in 3 cases; III. Required Documentation: An evaluation from the director of the applicant's fellowship training program that included peripheral catheter-based interventions;

AND An evaluation from the applicant’s clinical educator/preceptor of the SilverHawk™ Peripheral Plaque Excision System.

Note: If privileges in the use of the SilverHawk™ Peripheral Plaque Excision System are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence in performance of the SilverHawk™ Peripheral Plaque Excision System procedure as reflected in the applicant's quality profile;

AND Evidence of continuing medical education related to peripheral catheter-based interventions.

Date__________________

Applicant’s Signature_______________________________________________

Date__________________

Department Chair’s Signature________________________________________

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FDA SilverHawk Peripheral Plaque Excision System, 510(k) Summary, Indications for Use, http://www.fda.gov/cdrh/pdf5/k053460.pdf 2

These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by the American College of Cardiology, American College of Physicians, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and biology, and the Society for Vascular Surgery, "Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions", http://www.cardiosource.com/guidelines/competence/pvd/index.pdf 3

For additional information on training options and availability, contact FoxHollow Technologies, Inc., http://www.foxhollowtech.com/wt/page/contact_company

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital Criteria for Privileges in STEREOTACTIC BREAST BIOPSY I. Definition: A procedure where the physician passes a hollow needle through the skin into the suspicious lesion with the help of special breast x-rays that use computerized mammography with intersecting coordinates to pinpoint the area of tissue change. The sample of breast tissue obtained in this way can show whether the lesion is malignant or benign. http://www.radiologyinfo.org/en/info.cfm?pg=breastbixr II. Eligibility: Core privileges in general surgery, pediatric surgery, interventional radiology, diagnostic radiology or radiology;

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Training in the performance of stereotactic breast biopsy as part of a residency training program ; AND Meet the initial qualification specified in the ACR Practice Guideline for the Performance of Screening Mammography 2

and the ACR Practice Guideline for the Performance of Diagnostic Mammography 3 or should review the mammographic finding with a MQSA-qualified physician.1

OR In addition to the qualification requirements stated above, successful completion of an appropriate training program in the performance of stereotactic breast biopsy that includes 3 hours of Category 1 CME didactic instruction in stereotactically guided biopsy and performance of at least three stereotactic breast biopsy procedures under the 1 supervision of a qualified physician ;

AND Demonstration of current clinical competence by performance of a minimum of 12 stereotactic breast biopsy 1 procedures during the last 12 months. III. Required Documentation: An evaluation from the director of the applicant's residency training program that included stereotactic breast biopsy OR from the director of another appropriate training program in stereotactic breast biopsy;

AND An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform stereotactic breast biopsy or from another professional colleague who has direct knowledge of the applicant's competence to perform stereotactic breast biopsy;

AND Documentation of CMEs related to knowledge and technical skill in stereotactic breast biopsy.

Note: If privileges in stereotactic breast biopsy are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence by performance of at least 12 stereotactic breast 1 biopsy procedures during the past 12 months ;

AND Evidence of continuing medical education ( 3 hours Category 1 CME) in stereotactic breast biopsy procedures every 1 3 years.

_____________________________________ Applicant’s Signature

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_____________________________________ Department Chair’s Signature

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These are the minimum requirements for a physician to establish and maintain proficiency in performing this procedure that were recommended by the American College of Radiology in "ACR Practice Guideline for the Performance of Stereotactically Guided Breast Interventional Procedures". http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/breast/stereotactically_guide d_breast.aspx 2

These recommendations can be found in the American College of Radiology document, "ACR Practice Guideline for the Performance of Screening Mammography". http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/BreastImagingandInterventio n/ACRPracticeGuidelineforthePerformanceofScreeningMammographyDoc4.aspx 3

These recommendations can be found in the American College of Radiology document, "ACR Practice Guideline for the Performance of Diagnostic Mammography". http://intranet.alemana.cl/lac_intraclinica/Mbe/GPC/Guidelines/Radiologia/diagnostic_mammo.pdf

Approved by Department: 8/00; 10/12 Approved by Credentials Committee: 10/00; 10/12 Approved by Medical Executive Committee: 11/00; 11/12 Approved by Board of Directors: 12/00; 12/12

St. John’s Hospital Criteria for Privileges in THORACIC AORTA ANEURYSM REPAIR (GORE TAG THORACIC ENDOPROSTHESIS) I. Definition: The GORE TAG Thoracic Endoprosthesis is used for endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who have appropriate anatomy including: • Adequate iliac/femoral access • Aortic inner diameter in the range of 23-37 mm • >2 cm non-aneurysmal aorta proximal and distal to the aneurysm http://www.fda.gov/cdrh/pdf4/p040043a.pdf The GORE TAG Thoracic Endoprosthesis is used to repair aneurysms of the aorta in the chest. It is an endovascular graft made of ePTFE (expanded polytetrafluoroethylene), with an outer metallic support structure. Each endovascular graft is compressed into the end of a long, thin, tube-like device called the delivery catheter. The delivery catheter containing the endovascular graft is inserted into the artery in the groin through a small surgical incision. It is carefully guided within the artery through the abdomen into the chest to bridge the site of the aneurysm in the aorta. The endovascular graft is then deployed and self-expands o the diameter of the aorta, to exclude the aneurysm and reline the artery wall. This can prevent further growth and possible rupture of the aneurysm. New Device Approval, GORE TAG Thoracic Endosprosthesis-P04003 http://www.fda.gov/cdrh/mda/docs/p040043/html II. Eligibility: Core privileges in vascular/endovascular surgery or vascular and interventional radiology or vascular surgery; AND Demonstrate experience in one of the following ways prior to the GORE TAG Thoracic Endoprosthesis physician 1 training program;

Physician Experience PRIOR to Course

Number of Post Course Training Cases Required

Participated as a partner in at least 3 Gore TAG device procedures & 5 endo-AAA procedures (or 8 Gore TAG Device cases) within the past 2 years.

1

Listed as a Clinical Investigator in a thoracic endograft trial other than the Gore TAG device. Participated in 5 or more thoracic endograft procedures within the past 2 years (no compassionate use or cuff usage)

1

Participated in 25 or more endo-AAA procedures within the past 2 years

3

Entering into training by partnering with a physician who has met one of the criteria above

5

III. Required Documentation: An evaluation from the certified Gore Associate of the applicant’s formal GORE TAG 1 Thoracic Endoprosthesis training program; Note: If privileges in the GORE TAG Thoracic Endoprosthesis procedure are granted, the exercise of the privileges shall be proctored as outlined in the hospital’s provisional appointment policy. IV. Reappointment: Demonstration of continuing competence in performance of the GORE TAG Thoracic Endoprosthesis procedure as reflected in the applicant’s quality profile during the past 24 months; AND

Evidence of continuing medical education related to thoracic aorta aneurysm repair procedures. Date______________

Applicant Signature_______________________________________________

Date______________

Department Chair Signature________________________________________

1 The GORE TAG Thoracic Endoprosthesis training is an FDA-mandated, two-day course that includes didactic instruction, viewing two videos and one live thoracic aorta aneurysm repair case, film reading and case planning. Individuals who complete the two-day course are required to complete training cases that meet the criteria in the Instructions for Use (IFU) and must be performed with a certified Gore Associate. Please note: The IFU document, page 15 states: Clinical Use Information WARNING: Always have a surgical team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary. WARNING: The GORE TAG Thoracic Endoprosthesis should only be used by physicians experienced in vascular interventional techniques, and who have successfully completed the appropriate physician training program. The recommended skill-knowledge requirements for physicians using the GORE TAG Thoracic Endoprosthesis are outlined below: Patient Selection · Knowledge of the natural history of thoracic aortic disease and co-morbidities associated with endovascular repair of the descending thoracic aorta. · Knowledge of radiographic image interpretation, device selection and sizing. A multi-disciplinary team that has combined procedural experience with: · Vascular access techniques · Guidewire and catheter techniques · Fluoroscopic and angiographic image interpretation · Embolization · Angioplasty · Endovascular stent placement · Snare techniques · Appropriate use of contrast agents · Techniques to minimize radiation exposure · Expertise in necessary patient follow-up modalities http://www.fda.gov/cdrh/pdf4/P040043c.pdf

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12

St. John’s Hospital VISUALASE THERMAL THERAPY (VTT™) (LASER-INDUCED INTERSITIAL THERMAL THERAPY- LITT) I. Definition: Visualase Thermal Therapy (VTT™) is an integrated solution for real-time monitoring and control of LITT using magnetic resonance imaging (MRI). MRI images of the treatment allow the user to monitor the progress of the therapy. Built-in control for the laser included in the workstation eliminates the need to toggle controls on multiple instruments during the treatment. Laser-induced interstitial thermal therapy (LITT) is a minimally invasive therapy for the treatment of solid tumors that uses laser light to destroy the affected tissue through heat. In LITT, fiber optics are placed directly into the tumor to deliver laser light energy within the desired region of treatment. After proper positioning of fibers target tissues are irradiated using infrared light. Absorption of light energy by the tissue volume results in volumetric heating which ultimately leads to thermal destruction of the tumor. http://www.visualase.net/products.html Indications for Use: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nosethroat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected 1 points may be monitored and/or displayed over time. http://www.fda.gov/cdrh/pdf8/K081656.pdf II. Eligibility: Core privileges in general surgery, interventional radiology, neurosurgery, or urology;

2

AND Current working knowledge of laser, laser operation and laser safety; AND Successful completion of a required Visualase Thermal Therapy (VTT™) System training course by approved 2 company engineers and sales professionals at the physician’s site during installation and testing of equipment. AND Documented supervision of initial 3 VTT™ procedures by an approved Visualase clinical site engineer and sales 2 professional. III. Required Documentation: Documentation of successful completion of the Visualase Thermal Therapy (VTT™) System training under the supervision of approved clinical site engineers and sales professionals. Note: If privileges to perform the VTT™ procedure are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence in performance of the VTT™ procedure as reflected in the applicant’s quality profile; AND Evidence of continuing medical education as related to current technology in laser therapy.

Date________________ Applicant’s Signature__________________________________________________ Date________________ Department Chair’s Signature___________________________________________ 1

FDA 510(k) Summary, Visualase® Thermal Therapy System Indications for Use http://www.fda.gov/cdrh/pdf8/K081656.pdf 2

These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by Visualase. For further information please contact Visualase [email protected].

Approved by Department Chair: 10/12 Approved by Credentials Committee: 10/12 Approved by Medical Executive Committee: 11/12 Approved by Board of Directors: 12/12