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"Open Heart Surgery


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  • 1. Open Meeting on Rules Redevelopment Illinois Health Facilities Planning Board April 12, 2006 “Open Heart Surgery” “Cardiac Catheterization” REFERENCE MATERIAL Harold Washington College Community Room #203 30 E. Lake StreetRules Chicago, ILRedevelopment Teleconference: Illinois Department of Public HealthIllinois 2nd Floor Conference RoomHealth Facilities 525 West. Jefferson StreetPlanning Board Springfield, IL 1
  • 2. Reference Topics Definitions Program Requirements Proposed Requirements for ICC, DCC, and Cardiac Surgery ACC/SCAI Requirements for CC in Freestanding Settings Utilization Standards for Other States Necessity of On-Site Surgical Component On-Site Surgical Component Unnecessary On-Site Surgical Component Necessary Follow-Up Cardiac Catheterization Databases Database Tools/Systems Options Follow-Up Procedures for Other StatesRulesRedevelopmentIllinoisHealth FacilitiesPlanning Board 2
  • 3. Definitions Angioplasty – medical procedure in which a balloon is used to open narrowed or blocked blood vessels of the heart. It is not considered to be a type of surgery. Medline Plus Medical Encyclopedia Elective PCI – PCI techniques used to treat patients in stable conditions. American College of Cardiology PCI (Percutaneous Coronary Intervention) – Initially limited to balloon angioplasty; also known as Percutaneous Transluminal Coronary Angioplasty (PTCA); includes new techniques capable of relieving coronary narrowing, such as: rotational atherectomy, directional atherectomy, extraction atherectomy, laser angioplasty, implantation of intracoronary stents and other catheter devices for treating coronary atherosclerosis. American College of Cardiology Primary PCI – PCI techniques used to treat severely ill patients, experiencing diagnoses of acute atherosclerosis, acute MI, etc. American College of CardiologyRulesRedevelopmentIllinoisHealth FacilitiesPlanning Board 3
  • 4. Discussion of Requirements for DCC, ICC, and Cardiac Surgery * DIAGNOSTIC INTERVENTIONAL CARDIAC SURGERY Need Limited to Adult Patients; Applicant facility is located > Provide evidence that at least 60 min from existing facilities 1,000 DCC services were performed Determination providing ICC and cardiac w/in the latest 12-month period at Applicant located > 45 min from existing facility; surgery; applicant facility; OR OR Establishment of ICC is done Document a historical volume of All existing facilities in conjunction w/ the at least 200 patients directly w/in 45 min travel time establishment of cardiac referred following DCC at operate > 400 DCC/yr; OR surgery –AND- at least 1,000 applicant facility to other DCC have been performed institutions for cardiac surgery for w/in the latest 12-month each of the last 2 yrs. Establishment is period. necessary to alleviate excessively high demands on an existing facility’s “DCC” lab Minimum At least 200 DCC At least 150 cardiovascular During 2nd year of operation, will examinations annually interventions based on: perform at least 150 cardiac Utilization - At least 1,000 DCC w/in the surgeries and during 3rd year of last 12 months; OR operation, at least 300 cardiac - Historical data re: transferred surgeries will be performed. to other facilities for thisRules service; ORRedevelopment - Evidence of sufficient number of potential patients who will need the service and would NOT use other facilities.IllinoisHealth FacilitiesPlanning Board * American College of Cardiology 4
  • 5. Discussion of Requirements for DCC, ICC, and Cardiac Surgery * DIAGNOSTIC INTERVENTIONAL CARDIAC SURGERY Continuity of Written transfer Must document on-site cardiac None Stated agreements established surgery capability; OR Care w/ facilities providing ICC and cardiac surgery Written transfer agreement for seriously ill patients assuring access w/in one hour to a cardiac surgery “OR” in a nearby facility for the transfer of seriously ill or emergency patients Support Must document the None Stated Must be available on 24-hr basis and following support how services will be mobilized in Services services: Nuclear emergencies: Surgical and cardiology Medicine; team; cardiac surgical ICU or Electrocardiography; dedicated post-op ICU beds; ER w/ Pulmonary function unit; full-time director staffed 24-hrs for Blood bank; Hematology cardiac emergencies; DCC & ICC; lab-coagulation lab; Nuclear med lab; Cardiographics lab Microbiology lab; Blood including all non-invasive testing; Gas lab; Clinical echocardiography service; hematology Pathology lab w/ facilities lab; microbiology lab; blood gas and for blood chemistry; CT or electrolyte lab w/ microtechniques for other diagnostic imaging ped patients; electrocardiographic lab; services blood bank and coagulation lab; pulmonary function lab; installation ofRules pacemakers; organized Must be available on 24-Redevelopment hr basis on-site or w/in 30 cardiopulmonary resuscitation team min travel time or capability; preventative biomedical maintenance program; and renal dialysisIllinoisHealth FacilitiesPlanning Board * American College of Cardiology 5
  • 6. Discussion of Requirements for DCC, ICC, and Cardiac Surgery * DIAGNOSTIC INTERVENTIONAL CARDIAC SURGERY Staffing None Stated At least 1 interventional 2 Cardiologists w/ special competence cardiologist available on a full- in cardiology; time basis residing w/in 30 min O.R. nurse personnel (RN, LPN, Surgical travel time of the facility Technician); Lab director and staff who Bd. Certified or eligible possess qualifications consistent Anesthesiologist; w/ latest published ACC Adult Cardiologists (Bd. Certified or guidelines eligible); Staff meeting requirements of Physician (Bd. Certified or eligible) in 77 ill. Adm. Code 1110.1230©. anatomic and clinical pathology w/ special expertise; Pump Technician w/ in-depth experience; Radiology Technologist Assurances Must Certify: Lab Same as required for DCC Must certify: Implementation of Peer Director and staff per Review program to evaluate the quality of guideline of ACC; cardiac surgeries, outcomes, technical Implementation of Peer aspects of service; Participation in Review Group prior to cardiovascular surgery data registry; No 1st exam; Participation in cardiac surgeries performed on Peds NCDR; Report to State patients; Periodic reports re: volume, Board of any ICC or comparison of outcomes to latest cardiac surgery published results of Society of ThoracicRules performed; No exams Surgeons Semi-annual report;Redevelopment performed on Peds acknowledgement that failure to comply patient; Submission of w/ all constitutes abandonment of the periodic reports re: Cardiac Surgery category of service volume & comparison ofIllinois outcomes for exams;Health FacilitiesPlanning Board * American College of Cardiology 6
  • 7. Discussion of Requirements for DDC, ICC, and Cardiac Surgery * Diagnostic Interventional Cardiac Surgery Performance Document compliance Document compliance w/ assurance Document compliance w/ w/ assurance standards standards assurance standards Requirements 200 exams performed Perform >150 cardiovascular W/in 2 yrs of initial cardiac for latest 12 mo period, interventions for latest 12 mo period, surgery, >100 surgeries w/in 2 yrs after date of w/in 2 yrs after date of initial performed for latest 12 mo initial exam cardiovascular intervention period Verify patient outcome Perform >400 cardiovascular During 3 rd year after initial consistency w/ latest intervention and cardiac surgeries surgery, >400 interventions and ACC guidelines; OR (combined), consisting of >150 surgeries performed Document interventions and >150 surgeries, or if (combined) consisting of >150 implementation of CQI not performing surgeries, >200 interventions and >150 program, providing for interventions, all w/in 3rd year after surgeries periodic review every 6 date of initial intervention Verify patient outcome mo by professionals w/ Verify patient outcome consistency consistency w/ latest ACC & expertise in DCC with latest ACC guidelines Society of Thoracic Surgeons guidelines Abandonment Failure to comply with Same as required for DCC Same as required for DCC requirements prior to project completion shall constitute failure to proceed w/ due diligence and result in abandonment ofRules category of service,Redevelopment unless Board approves otherwise.Illinois * American College of CardiologyHealth FacilitiesPlanning Board 7
  • 8. ACC/SCAI * Req. for CC in Freestanding Settings IN-HOSPITAL w/o MOBILE AMBULATORY CARDIAC SURGERY FREESTANDING FREESTANDING Diagnostic catheterization procedures Apply same criteria and review As of now, outpatient coronary can be performed safely/efficiently standards as in-hospital w/o cardiac intervention or cardiac Interventional procedures of any kind surgery lab catheterization in the ambulatory should not be performed setting is not approved by Must have a formal relationship with To be eligible for study in mobile cath ACC/SCAI at least 1 tertiary referral hospital to labs, patients must meet same criteria as establish written plan for emergency traditional environments transfer or patients Must have equipment for intubation and ventilatory support Physicians must be capable of performing endotracheal intubation and intra-aortic balloon pump insertion Quality Assurance and Quality Improvement programs must be documentedRulesRedevelopmentIllinoisHealth Facilities * SCAI = The Society for Cardiovascular Angiography and InterventionPlanning Board 8
  • 9. CON Utilization Standards for Other States STATES DCC ICC SURGERY ALASKA Adult – 750/yr Adult – 750/yr 1st year – 100 Pediatric – 250/yr Pediatric – 250/yr 5th year - 250 FLORIDA Adult - 300/yr Adult - 300/yr Adult – 300/yr Pediatric -150/yr Pediatric – 150/yr Pediatric – Determination on regional basis GEORGIA 1st year – > 100 1st year – > 100 N/A 2nd year – > 200 2nd year – > 200 3rd year - > 200 3rd year - > 200 ILLINOIS 200/yr w/ in 2 years after 200/yr w/ in 2 years after Adults – 200/yr w/in 3 yrs initiation initiation of initiation Pediatrics – 75/yr w/in 3 yrs of initiation IOWA Adult – 300/yr Adult – 300/yr Adults – 350/yr Pediatric -150/yr Pediatric -150/yr Pediatric – 75/yr KENTUCKY > 500 in past 12 mo >1,100 in the past 12 mo Adult - > 400 in 3rd year Peds - > 100 in 3rd year MICHIGAN Adult – > 300 in 2nd year Adult – > 300 in 2nd 12 mo Adult – 300/yr after date of first procedure Pediatric - > 150 in 2nd 12 Pediatric – 100/yr Peds – > 450 in 2nd year mo after date of first procedureRules NEW HAMPSHIRE > 250/yr > 250/yr > 350/yrRedevelopment NEW JERSEY Adult - At least 400/yr Adult - At least 200/yr Adult – 350/yr; Ped – 150/yrIllinoisHealth Facilities N/A: Information not availablePlanning Board Other States CON Standards Not Available 9
  • 10. CON Utilization Standards for Other States STATE DCC ICC SURGERY NEW YORK Adult - > 400/yr N/A Adult – 500 w/in 3rd year Pediatric – > 100/yr Pediatric – 50/yr TENNESSEE Adult – 500/yr Adult – 500/yr Adult – > 200 w/ in 3 years Pediatric – 200/yr Pediatric – 200/yr of service initiation Pediatric – > 100 w/ in 3 years or service initiation VIRGINIA Adult – 1st year: 200; 2nd year: Adult – 1st year: 200; 2nd year: Adult – 1st year: 150; 2nd year: 500; 3rd year: 800 500; 3rd year: 800 250; 3rd year: 400 Pediatric – 1st year: 100; 2nd year: Pediatric – 1st year: 100; 2nd Pediatric – N/A 200; 3rd year: 400 year: 200; 3rd year: 400 WEST VIRGINIA > 1000/yr w/ in 3 yrs after date > 1000/yr w/ in 3 yrs after > 250/yr w/in 3 yrs after of service initiation date of service initiation date of service initiationRulesRedevelopmentIllinoisHealth FacilitiesPlanning Board N/A: Information not available Other States CON Standards Not Available 10
  • 11. Necessity of On-Site Surgical Component Position #1: On-Site Surgical Component Unnecessary Intracoronary Stenting has decreased the need for bypass surgery by .4% to 2% Bypass surgery for a severely ill patient is more often associated with a higher mortality rate than elective surgery Emergency surgical procedures is also associated w/ higher rates of perioperative infarction and less frequent use of arterial conduits Utilization and success of DCC and ICC to treat acute MI questions the need for on-site cardiac surgery Survival rates following emergency angioplasty for heart attack are the same regardless of the availability of on-site cardiac surgery Primary PCI w/o On-Site Cardiac Surgery * Different phases in MI may require a more highly skilled staff with more experience • If highly skilled staff not available, transferring patient to surgical center will be more effective, efficient ACC/AHA Committee approves primary PCI in hospitals w/o an on-site surgery component,Rules • However, it should be restricted to institutions capable of performingRedevelopment 36 angioplasty procedures/year with a proven plan for rapid and effective elective PCI as well as timely access to cardiac surgical center in a nearby facilityIllinoisHealth Facilities * ACC/AHA Guidelines for Percutaneous Coronary InterventionPlanning Board 11
  • 12. Necessity of On-Site Surgical Component Position #2: On-Site Surgical Component Necessary Elective PCI w/o On-Site Cardiac Surgery * Expressed concern still exists due to several issues: management of ischemic complications, adequacy of post- interventional care, logistics for managing cardiac surgical or vascular complications and operator/laboratory volumes, and accreditation Complications can create a need for surgical emergency ACC/AHA Committee recommends that elective PCI should not be performed in facilities w/o on-site cardiac surgeryRulesRedevelopmentIllinoisHealth FacilitiesPlanning Board * ACC/AHA Guidelines for Percutaneous Coronary Intervention 12
  • 13. Cardiac Catheterization Databases • DATABASE TOOLS/SYSTEMS OPTIONS ACC-NCDR * ACC-CathKIT A confidential quality measurement Web-based interactive resource w/ key program for cardiac and vascular facilities info and tools needed to improve quality of care Provides quarterly institutional reports containing national and peer group stats Knowledge repository of cath lab info, relating to DCC and ICC procedures including regulations, guidelines, benchmarks, tools/templates, and standards Contains key performance indicators, i.e. patient demographics, history/risk factors, cardiac status, treated lesions, intracoronary Designed for cath lab care team to device utilization, adverse outcomes improve systems, processes, and patient outcomes. Includes data from more than 500 institutions and over 1.6 million patient dischargesRulesRedevelopment •OTHER OPTIONS: •C-PORT: Cardiovascular Patient Outcomes Research TeamIllinois •Medicare Outcome/Performance DatabaseHealth FacilitiesPlanning Board * ACC-NCDR: American College of Cardiology – National Cardiovascular Data Registry 13
  • 14. Cardiac Catheterization Databases • KEY FEATURES ACC-NCDR * ACC-CathKIT Benchmarking –accurate data to use for ACC/AHA Practice Guidelines internal, peer hospital and national Updated info on regulatory challenges benchmarking Performance benchmarks Timely reports – quarterly and annual Info regarding facility/environment outcome reports requirements Useful clinical data – standardized clinical Budgetary/financial planning info elements and definitions Job descriptions, training requirements, Networking – annual user-group meetings and credentialing and training materials Clinical practice tools and templates Educational support – training materials and specially trained clinical and technical Guidance on building relations with state staff regulators and JCAHO Tutorials on implementing CQI programsRules Self-evaluation checklist reportsRedevelopment Receive CME and CE through the ACCFIllinoisHealth FacilitiesPlanning Board * American College of Cardiology – National Cardiovascular Data Registry 14
  • 15. Follow-Up Procedures for Other States STATE FOLLOW UP PROCEDURES ALASKA Failure to comply with review standards set forth by the Department of Health and Social Services will result in suspension or revocation of license depending on degree of noncompliance FLORIDA Noncompliance w/ the standards set forth by the Agency for Healthcare Administration will subject the facility to a fine of up to $1,000 per day and revocation of license. ILLINOIS Failure to comply w/ the standards set forth by the Health Facilities Planning Board will result in service abandonment KENTUCKY Failure to comply with the review criteria set forth by the Kentucky Cabinet for Health and Family Services will result in a fine to be determined by degree of noncompliance MISSOURI Any person/facility failing to comply with the review standards set forth by the Department of Health and Senior Services will be subjected to a fine to be determined NEW JERSEY Failure to comply with the requirements set forth by the Department of Health and Senior Services can result in revocation of facility license for up to 12 months unless an appeal is filed w/in 60 days OHIO Failure to comply with standards presented by the Department of Health will result in notification of facility of license withdrawal TENNESSEE Failure to comply w/ the Department of Health Services and Development Agency review standards will result in revocation of license VIRGINIA Failure to document compliance or progress w/ the Department of Health will result in license revocationRulesRedevelopmentIllinoisHealth FacilitiesPlanning Board N/A: Information not available Other State CON Standards Not Available 15