ADVANCED AORTIC TRANS CATHETER VALVE PLACEMENT CLINICAL PRIVILEGES Delineatin f Clinical Privileges Criteria fr granting privileges: Maintain clinical privileges at the facility in an apprpriate specialty. Participate in the structured MHMH TAVR prgram. Applicants will be requested t prvide dcumentatin f practice and current clinical cmpetence as defined n the attached cmpetency grid. Applicants have the burden f prducing infrmatin deemed adequate by the hspital fr a prper evaluatin f current clinical cmpetence and ther qualificatins and fr reslving any dubts. Current Clinical Cmpetence - MLH In additin t the required educatin, experience and/r training specified n each DOP (Delineatin f Privilege) frm, dcumentatin f current clinical cmpetence is required. Current clinical cmpetence is described as having perfrmed the privilege recently and perfrmed it well. Current clinical cmpetence is assessed prir t granting privileges initially and is reassessed when renewing privileges at reappintment fr maintenance f privileges. Current Clinical Cmpetence (CCC) may be lcatin specific (acute hspital care, surgery center) and/r age specific (adult, pediatric, nenatal). This shuld nt be cnfused with Fcused Prfessinal Practice Evaluatin (FPPE) FPPE: an evaluatin f clinical cmpetence f all new privileges as perfrmed at the specific licensed MLH facility (MHMH, MHOBH) fr which they have been initially granted. This applies t privileges fr all new applicants as well as t new/additinal privileges fr current members. Bth FPPE and current clinical cmpetence assessments are privilege-specific. FPPE is cnducted during the perid after granting new/additinal privileges. FPPE must ccur at the MLH facility(ies) where privileges/membership are held. Current clinical cmpetence may be evaluated frm case lgs prvided by nn-mlh facilities. Current Clinical Cmpetence: Requirements fr New Applicants If applying directly frm training, r based n the training received in a frmal training prgram, prvider shuld submit case* lgs frm the prgram authenticated by the prgram directr alng with their recmmendatin attesting t the cmparable training, experience and qualificatins relative t the criteria fr the clinical privileges requested. If applying mre than 1 year after training cmpletin, submit the fllwing: Aggregate data frm acute care r surgery center facility fr the previus 12 mnth time perid, identifying the tp 10 diagnsis cdes and the number f patients per cde. Any cmplicatins/pr utcmes shuld be delineated and accmpanied by an explanatin. Prcedure list frm acute care r surgery center facility fr the previus 12 mnth time perid, identifying the tp 10 CPT/ICD cdes and the number f prcedures per cde. Any cmplicatins/pr utcmes shuld be delineated and accmpanied by an explanatin. Case lgs (see specificatins belw) fr any special privileges requested that meet the criteria specific fr the number f prcedures defined fr current clinical cmpetence. 1
Current Clinical Cmpetence: Maintenance f Privileges fr Current Members Fr active staff members: MLH surce data will be aggregated t review cases and prcedures perfrmed. and/r special privileges, the practitiner will be required t submit additinal case lgs frm ther facilities. If this des nt meet the minimum requirement fr cre Fr curtesy staff members with lw activity and fr certain active staff with activity that has diminished and is nw lw: Department chair recmmendatin shuld be btained frm their primary facility; and the practitiner shuld submit the fllwing: Aggregate data frm acute care r surgery center facility fr the previus 12 mnth time perid, identifying the tp 10 diagnsis cdes and the number f patients per cde. Any cmplicatins/pr utcmes shuld be delineated and accmpanied by an explanatin. Prcedure list frm acute care r surgery center facility fr the previus 12 mnth time perid, identifying the tp 10 CPT/ICD cdes and the number f prcedures per cde. Any cmplicatins/pr utcmes shuld be delineated and accmpanied by an explanatin. Case lgs (see specificatins belw) fr any special privileges requested that meet the specific number f prcedures defined fr current clinical cmpetence. Case Lgs All required case lgs and/r prcedure lists must cntain the fllwing infrmatin at a minimum: Date, patient identifier, CPT/ICD prcedure cde, diagnsis, cmplicatins, and dispsitin, and the facility name, name/title f the persn authenticating the lg, signature, date signed, and cntact infrmatin. If the infrmatin requested is nt available, please prvide an explanatin. *A case is defined as an episde f care either cgnitive r prcedural. Fr interpretive care, case is interpretatin f ne diagnstic study. Onging Prfessinal Perfrmance Evaluatin (OPPE) OPPE is evaluated peridically (mre frequently than annually) in the facility where membership/privileges are held. T assure OPPE requirements are satisfied, the practitiner must peridically exercise the privileges in the MLH facility(ies) where he/she has membership. OPPE must ccur regularly n patient encunters in the MLH facility(ies) where privileges/membership are held. 2
Advanced Artic Trans Catheter Valve Placement Privileges Indicatins fr Use: Severe, symptmatic artic stensis >20% perative mrtality risk Severe ascending arta calcificatin (prcelain arta) that prevents artic cannulatin r crss-clamping Severe radiatin damage t the chest r ther severe chest defrmities that wuld preclude a sterntmy (transcatheter apprach used because radiatin damage may als prevent a transapical apprach) Patients willingness t cmply with fllw-up evaluatins t assist with nging develpment f this new technlgy and ethics bards that apprve studies with these valves Cntraindicatins fr transcatheter and transapical artic valve replacement: Previusly untreated crnary disease (the valve may prevent access fr percutaneus crnary interventins althugh successful stent placement after implantatin f a transcatheter valve has been reprted) N cncmitant crnary artery bypass surgery with transapical artic valve replacement because the expsure wuld be inadequate Infective endcarditis r intracardiac tumr (excisin n bypass is the nly accepted treatment fr intracardiac tumr) Estimated life span f less than 1 year (wuld limit fllw-up f investigatinal valves) Recent active gastrintestinal bleeding that wuld prhibit use f heparin r antiplatelet therapies such as aspirin r clpidgrel Patients with a cntraindicatin t transesphageal echcardigraphy (used preperatively t assess artic annulus size and t psitin the valve) Artic annulus size nt amenable t use with the currently available valve sizes (valve sizing is critical t avid paravalvular regurgitatin) Anmalus crnary stia (valve culd ptentially interfere with flw int anmalus crnary stia) r an unusually bulky crnary leaflet Renal failure with creatinine clearance <20 ml/min Fr transcatheter artic valve replacement nly: severely calcified, diseased, small r trtuus iliac vessels that preclude passage f the delivery catheter r previus artbifemral grafting (these patients wuld qualify fr transapical artic valve replacement) r artic aneurysm Fr transapical artic valve replacement nly: left apical clt, aneurysm, r scar (these patients wuld qualify fr transcatheter artic valve replacement); left ventricular clt culd be a cntraindicatin fr transcatheter Patient ffered cnventinal artic valve replacement but refused surgery 3
Specialty/Prcedure Delineatin f Privilege Frm Educatin/Training Dcumentatin fr Initial Granting Initial Applicatin (Prf f current clinical cmpetence) FPPE Validatin f cmpetence after appintment and/r granting f a new r additinal privilege (T be cmpleted within ne year) Maintenance Requirements Advanced Artic Trans Catheter Valve Placement Privileges Maintain current clinical privileges at facility in either Cardi Thracic Surgery r Interventinal Cardilgy, CME including successful cmpletin f didactic training in Advanced Artic Trans Catheter Valve Placement as part f the structured TAVR training prgram and dcumented by a Certificate f Cmpletin frm Edwards LifeSciences Participatin in the structured TAVR prgram at MHMH Success and cmplicatin review t include 100% f cases. Case lg dcumenting the perfrmance f prcedures annually ver the reappintment cycle sufficient t maintain current clinical cmpetence and participatin in the structured TAVR prgram at MHMH, and adherence t established patient selectin criteria. Bard apprved: March 21, 2012, Revised 4/16/14
Advanced Artic Trans Catheter Valve Placement Clinical Privileges Check belw the particular privileges desired fr each facility: Privilege Descriptin Age Limitatins Advanced Artic Trans Catheter Valve Placement Limitatins Nenates (0-28 days) Please check ( ) applicable age categries fr each privilege requested. Methdist Healthcare Memphis Hspitals (MHMH) Germantwn, Le Bnheur Medical Center, Nrth, Suth & University, Outpatient Clinics & Diagnstic Facilities Infants Children & Adlescents (29 days 2 Years) (2-18 years) Adults & Adlescents (13 & Abve) Clinical privileges are granted nly t the extent privileges are available at each facility. Adults (18 & Abve) Darkly shaded areas represent privileges nt available t any practitiner due t the privilege nt being ffered by the facility. Acknwledgement f practitiner I have requested nly thse privileges fr which by educatin, training, current experience and demnstrated perfrmance I am qualified t perfrm and fr which I wish t exercise at the facilities indicated abve t the extent services are available at each facility; and I understand that: (a) in exercising any clinical privileges granted, I am cnstrained by facility and medical staff plicies and rules applicable generally and any applicable t the particular situatin (b) any restrictin n the clinical privileges granted t me is waived in an emergency situatin and in such situatin my actins are gverned by the applicable sectin f the medical staff bylaws r related dcuments Physician's Signature Date Printed Name Bard apprved: March 21, 2012, Revised 4/16/14