Agency for Health Care Administration (AHCA) Pediatric and Congenital

Transcription

1 (Note: Still awaiting guidance for adding or removing this language.) Add Language: This Committee shall be consulted for Certificate of Need applications for new programs under the advisement of the Secretary of AHCA. The appointment of the Panel s Chair and Vice Chair shall be 2 year terms with a maximum of 4 years. The membership will be determined by local hospital CEOs, with the approval of the Secretary having designation of formal alternatives for voting members. The process of site review and issue of sovereign immunity will be addressed. (Note: This language was discussed at the 11/29/18 meeting as a potential edit for this document. Members will continue to discuss at the 12/13/18 meeting.) This Committee recommends for volume that the Pediatric Cardiology and Congenital Programs shall maintain a two star rating as determined by the STS. If the program drops below a two star rating, they are subject to a corrective action plan as determined by the PCTAP. Agency for Health Care Administration Agency for Health Care Administration (AHCA) Pediatric and Congenital Cardiovascular Centers undergo a quality assurance process that ensures such Pediatric and Congenital Cardiovascular Centers (PCCC) meet established minimum standards deemed necessary for the provision of quality cardiac services to children with special health care needs. AHCA supports the creation of policies to foster growth of Centers of Excellence. 1

2 The following standards are required for entering into, and continuing in, an agreement with AHCA as a PCCC. An AHCA Pediatric and Congenital Cardiovascular Center will consist of the following co-located components: I. Pediatric and Congenital Cardiology Clinic 35 II. Pediatric and Congenital Echocardiography Laboratory 36 III. Pediatric and Congenital Cardiac Catheterization Laboratory 37 IV. Pediatric and Congenital Cardiac Electrophysiology (EP) Program 38 V. Pediatric and Congenital Cardiovascular Surgery Program 39 VI. Advanced Congenital Cardiac Imaging An AHCA Pediatric and Congenital Cardiovascular Center must provide care for all PCCC enrolled individuals with congenital and acquired heart disease who require such expertise. For volume standard purposes, pediatric cardiac cases include children with congenital and acquired heart disease under age 21 years and adults 21 years or older with congenital heart disease For the purposes of AHCA Pediatric and Congenital Cardiovascular Center program evaluation, development and review, each distinct facility component will be surveyed 2

3 individually within a multi-site Pediatric and Congenital Cardiovascular Center. Each of its individual components must meet or exceed standards; that is, each hospital-based team must perform the minimum number of echocardiograms, catheterizations, electrophysiologic studies and surgeries specified herein. Each component in the AHCA Pediatric and Congenital Cardiovascular Center shall be evaluated based on its own merits. All AHCA Pediatric and Congenital Cardiovascular Centers must: 1. Be located within a healthcare facility that maintains accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or the National Committee for Quality Assurance (NCQA). 2. Be HIPAA (Health Insurance Portability and Accountability Act) compliant. 3. Provide limited English proficiency services, in accordance with Federal guidelines. 4. Have quality assurance and quality improvement processes in place that continuously enhance the clinical operation and patient satisfaction with services. 5. Actively participate in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. 6. Participate in the STS Congenital Heart Surgery Database Anesthesia Module. 3

4 Participate when fully developed in the Improving Pediatric and Adult Congenital Treatments (IMPACT) databases. 9. Collect and submit the following quality assurance data annually, from their annual STS Congenital Heart Surgery Database Report: 71 Number of patients/operations submitted and an analysis of operative 72 mortality, and complexity information, by year 73 Number of patient/operations in analysis, operative mortality, and complexity 74 information, by age group 75 Primary Procedure Operative Mortality 76 STS-EACTS (STAT) (European Association of Cardio-Thoracic Surgery) 77 Mortality Category Operative Mortality, by year 78 STS-EACTS (STAT) Mortality Category Operative Mortality, by age group All AHCA Pediatric and Congenital Cardiovascular Centers must implement electronic medical record technology. All AHCA Pediatric and Congenital Cardiovascular Centers with birthing centers must have a neonatal screening program using pulse oximetry to detect critical congenital heart disease. Data from such a screening program will be transmitted annually, by the involved institutions, to the AHCA. The Secretary of the AHCA shall request the 4

5 Surgeon General/Secretary of the Department of Health to forward to the Agency, the annual finding of this screening program. A multidisciplinary cardiac team must include pediatric cardiology, cardiovascular surgery, cardiovascular anesthesia, nursing, ancillary and support staff associated with pre-operative patient selection and preparation, the surgical or catheterization procedure, and post-operative care and follow-up All physicians and other licensed healthcare professionals that require credentialing through the Department of Health (DOH) or the Department of Business and Professional Regulation (DBPR) credentialing process and are providing care at an AHCA Pediatric and Congenital Cardiovascular Center must be credentialed providers, as specified in rule 64C Florida Administrative Code (F.A.C.) Facilities requesting to be involved as a AHCA Pediatric and Congenital Cardiovascular Center must submit a formal request to the Secretary of AHCA or designee, following the established Certificate of Need (CON) process

6 A. Each center shall submit at least two metrics to the American College of Cardiology ACPC Quality Network on a quarterly basis, or a frequency as designated by Qnet. Cardiac centers shall designate appropriate personnel for data collection and submission C. A pediatric cardiology clinic must be able to perform diagnostic evaluations including, but not limited to, echocardiographic recording, Holter monitoring, exercise testing, and serial pacemaker monitoring. They must either be able to perform fetal echocardiograms or have access to a fetal echocardiography facility. Each center must annually perform at least 50 procedures each for Holter monitor recordings and serial pacemaker monitoring procedures. Each center must annually perform at least 50 exercise testing studies. D. Fetal echocardiograms performed by a physician outside the physical boundaries of an IAC approved facility may be counted toward the required Facility Volume Standards so long as all of the following criteria are met: 1. The physician performing the fetal echocardiogram is on the medical staff of the hospital facility and affiliated with the hospital s pediatric cardiology program; 2. The physician performing the fetal echocardiogram is a credentialed pediatric cardiologist with training in or documented experience in fetal 6

7 echocardiography; Maternal-fetal medicine physicians in a PCTV shall involve the pediatric cardiology team prenatally in order to establish the continuum of care for the infant postnatally and to enable a relationship with the parents. 3. The program provides evidence that the physician maintains appropriate times of operation and protocols, including proper affiliation agreements to ensure availability and appropriate referrals in the event of emergencies; and 4. The fetal echocardiographic laboratory is accredited by IAC I. Pediatric and Congenital Cardiology Clinic 1. Pediatric and Congenital Cardiology Clinic: i) Physicians The physician in charge of a Pediatric Cardiology Clinic must be board-certified by the Sub-board of Pediatric Cardiology of the American Board of Pediatrics. Recertification or maintenance of competency (MOC) certificates of such a physician will be an integral component of all future program evaluations and development reviews. Board eligibility as an equivalent for board certification will not be considered as a criterion for credentialing beyond 5 years of eligibility unless a specific exception is made by the Secretary of AHCA or designee, upon the recommendation of the PCTAP. 7

8 Holter Monitoring Laboratory: A physician who is board certified in pediatric cardiology. 1. Personnel must have medical record access to previous Holter monitor studies and full print out of arrhythmias for comparison. 3. Exercise Treadmill Laboratory: a) A physician who is board certified in pediatric cardiology. b) A Basic Life Support (BLS) certified cardiology technologist or respiratory care practitioner immediately available. c) Pediatric Advanced Life Support (PALS) or ACLS trained personnel in close proximity when a pediatric study <15 years of age is being performed. d) The exercise treadmill lab must include a remote code button and telephone. e) Each center should have access to a metabolic exercise laboratory, in which oxygen utilization and the anaerobic threshold can be determined, as an adjunct to detecting early failing cardiopulmonary function. 8

9 f) All licensed PCCC institutions should follow the guidelines set forth in the American Heart Association Scientific Statement on "Clinical Stress Testing in the Pediatric Age Group" (Circulation. 2006; 113: ). g) Specifically, licensure as a PCCC requires that involved institutions: a) Maintain an appropriate pediatric exercise physiology laboratory, including 1) Age- and size-appropriate treadmill and/or cycle ergometer 2) Age- and size-appropriate blood pressure cuffs 3) Age- and size-appropriate oxygen saturation monitor 4) EKG recording equipment 5) An emergency resuscitation cart that includes emergency drugs, a defibrillator, supplemental oxygen, and a portable suction unit 6) A log demonstrating periodic testing of the defibrillator and oxygen supply, and periodic inspection of emergency drug expiration dates 9

10 b) Conduct all stress tests with at least one person trained in pediatric advanced life support (PALS) in the room at all times with the patient during the test c) Conduct all stress tests with a pediatric cardiologist immediately available (i.e. in the building) d) Perform a minimum of 50 pediatric exercise stress tests per year e) Obtain meaningful written consent for the stress test (which may be a hospital-wide standard consent form filled out specifically for stress testing) h) Licensed PCCC institutions are recommended to: a) Have oversight of the laboratory and testing procedures provided by a physician trained in exercise testing and exercise physiology b) Be able to perform spirometry/pulmonary function testing c) Be able to perform metabolic stress tests d) Be able to perform or refer patients for stress echocardiography e) Be able to perform or refer patients for pharmacologic stress testing 10

11 f) Be able to perform or refer patients for nuclear myocardial blood flow imaging 4. Serial monitoring and management of implanted electronic devices, such as pacemakers and defibrillators should be an integral component of any center. 5. Adult Congenital Heart Clinic- Each licensed PCCC must have a specific adult congenital heart clinic, listed by the Adult Congenital Heart Association (ACHA). Such a clinic should have a physician clinic director with special skills and expertise in dealing with adults with congenital heart disease. 6. Adult Congenital Heart Programs: i) All adults with congenital heart disease deserve access to appropriate care. ii) Each Pediatric and Congenital Cardiovascular Center must have as a goal to provide care in alignment with national standards, utilizing as guidelines those of the Adult Congenital Heart Association (ACHA). Each program, within 3 years, shall request a formal site visit by the staff of the AHCA. 11

12 iii) AHCA accredited Comprehensive Adult Congenital Heart Programs and regionalization of expertise are encouraged. iv) Existing national and international guidelines, which outline the care provided in adult congenital heart programs, should be utilized. v) All ACHD programs must be registered with the Adult Congenital Heart Association and submit required data at established intervals. vi) Personnel a) The program must be directed by a physician with special skills and training in caring for the adult patient with congenital heart disease. b) ACHD program directors shall be board certified by the ABIM ACHD sub-board. c) Congenital Heart Surgeon(s) with expertise in the unique surgical aspects and challenges of the adult congenital heart patient. d) Social Worker who is available to the adult patient to provide counseling and support services. 12

13 e) A health professional (ARNP or PA) whose role includes coordinating care for ACHD patients. f) Availability of Adult Medicine sub-specialty physicians to provide consultative care. g) All physicians caring for the adult congenital heart disease patient be ACLS certified. h) All staff performing exercise testing on adult congenital heart disease patient be ACLS certified. vii) Clinic Physical Space a) The clinic space used for evaluation of adult patients must be in accordance with their specific needs. b) Facility must be accessible to handicapped Individuals. c) Availability of EKG, X-Rays, MRI studies, Echocardiography, and exercise/metabolic stress testing d) Availability of a conference room for multi-disciplinary meetings. viii) Hospital and Inpatient Facilities a) The admitting facility must have expertise in the care of adults with congenital heart disease. 13

14 b) The ACHD Program must have access to a fully equipped cardiac catheterization laboratory with appropriately trained personnel. c) The ACHD Program must meet national standards in all cardiac catheterization interventional and electrophysiology procedures. d) The ACHD Program must offer a comprehensive cardiovascular surgical program, with established commitment from cardiac intensivists, anesthesiologists, and other adult medical and surgical subspecialties. ix) Patient Care Characteristics Specific to an ACHD Program Recommendations and Specific Requirements: a) Complete transition into the ACHD clinic should be individualized by the treating pediatric cardiologist, taking into account patient age, maturity, special psychosocial needs, and wishes of the parent(s). b) Adult female patients with congenital heart disease must have access to professional staff expert in the management of contraception and pre-pregnancy counseling. In addition, 14

15 Genetic Counseling and Fetal Echocardiography studies must be available. c) Pregnant patients with moderate to high complexity congenital heart disease must be evaluated as a High-Risk Pregnancy and referred to Maternal-Fetal Medicine Physicians. d) Health maintenance programs for adolescents and adult patients with CHD should be initiated by providing each patient with information related to, but not limited, to recommendations on endocarditis prophylaxis, anticoagulation therapy, diet, weight control, contraception, pregnancy risk and exercise limitations. e) There must be a major educational component that forms the foundation of the ACHD program that will advance public awareness, educate the medical and health care community and empower those individuals with adult CHD to have opportunities to be successful contributing adults to their respective communities. f) The ACHD program is strongly encouraged to develop partnership with sister institutions to do collaborative research, 15

16 cultivate working relationships and form advocacy groups to support their patients with CHD. 7. Annual updates on information submitted by each center to the ACHA regarding adult congenital heart disease activities should be forwarded to the AHCA program staff within 30 days of such submission. 8. High Risk Obstetrical Cases with Fetal Cardiac Anomalies- Each Pediatric and Congenital Cardiovascular Center must have an established protocol to address the needs of such patients, usually high-risk obstetrical cases having a cardiac fetal anomaly diagnosed by fetal echocardiography and/or ultrasound. F. Physical Facility General requirements for licensed and new PCCC outpatient clinics: 1. The area must be suitable for performance of a high quality cardiovascular examination. 2. Examination areas must be adequately lighted, have adjustable temperature, and offer privacy to patients. 3. A conference room must be available for discussing cases. G. Equipment - All clinic equipment must be monitored and maintained in accordance with manufacturers recommendations. 16

17 H. Radiological equipment- Access to a Radiological facility at which chest x- rays and other indicated radiological studies can be expeditiously performed, including access to Magnetic Resonance Imaging (MRI) studies, particularly to evaluate the large vessels of the chest associated with the heart. I. Records 1. Permanent record of real time study must include, at a minimum, video, disk, chart, or digital or electronic medical records. 2. Permanent record of real time study of Holter Monitoring studies must include one or more of the following: cassette tape, disk, printed paper, or digital or electronic medical records. 3. Permanent record of real time study of exercise treadmill testing must include EKG and blood pressure recordings. 4. Permanent record of real time study of serial pacemaker testing must be available. 5. Interpretation and final approval of study reports must be performed by a physician who is board certified in pediatric cardiology. 6. Medical records must be retained for a period of no less than seven (7) years in a locked area. 17

18 J. Initial Evaluation 1. Program evaluation and development review: If a request is received for involvement as a PCCC co-located Pediatric Cardiology Clinic, along with attestation of compliance with these standards, a program evaluation and development review may be requested by the Secretary of AHCA and performed by members or designees of the Pediatric Cardiac Technical Advisory Panel (PCTAP). A request for involvement shall not be deemed complete until the Secretary of AHCA or designee receives the recommendation of the PCTAP. 2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac cases within a specified time period must be available to warrant initial evaluation of any facility. 3. Facility and Practitioner Volume Standards: A facility requesting to participate as a licensed Pediatric and Congenital Cardiovascular Center must meet requirements for and have documentation of IAC accreditation. 4. Facility Criteria: include all standards in the PCCC co-located Pediatric Cardiology Clinic Component section. 5. The Secretary of AHCA or designee shall consider new facilities upon the completion of CON approval and requirements and the advisory 18

19 recommendation of the PCTAP and the criteria established above. The Secretary of AHCA or designee shall make the final decision on whether a facility may participate by entering into an agreement with the Agency for Health Care Administration. K. Re-evaluation of licensed Pediatric and Congenital Cardiovascular Centers 2. Facility and Practitioner Volume Standards: Meets requirements for IAC accreditation. 3. IAC Accreditation: By the initial or subsequent program evaluation and development review, all echocardiography laboratories, Transthoracic Echoes (TTE), Trans Esophageal Echoes (TEE) and Fetal Echoes (FE) must be accredited by the IAC, whether within the center or off-site. I. The Secretary of AHCA or designee considers existing facilities for continuing involvement upon the recommendation of the PCTAP and the criteria established above. The Secretary of AHCA or designee shall make the final decision on whether or not a facility may continue such an agreement with the Agency. 359 II. Pediatric and Congenital Echocardiography Laboratory A. Congenital Echocardiographic Imaging Laboratory Echocardiographic Imaging is a vital tool often relied upon by all of the other components of a Pediatric Cardiovascular Center. A Congenital 19

20 Echocardiographic Imaging Laboratory must be accredited (and reaccredited when accreditation expires) for Pediatric Echocardiography by the Intersocietal Accreditation Commission (IAC) in order to perform Transthoracic Echoes (TTE), Trans Esophageal Echoes (TEE) and Fetal Echoes (FE). The IAC accreditation process is a rigorous process that is constantly being improved and revised by national experts in this field. The IAC standards and guidelines spell out responsibilities for Echo Lab Medical Director, Technical Director, Medical Staff, Technical Staff, and for Support services. As well the IAC spells out standards and guidelines for the Echo Lab Facility, Echo examination reports and records, and Echo Lab safety. The IAC also mandates the facility must have a written Quality Improvement (QI) program for all imaging procedures. The IAC makes some accommodations for its standards and guidelines that may be a challenge for smaller Pediatric Cardiovascular Centers. The IAC standards and guidelines will not be separately listed here, details can be found at III. Pediatric Cardiac Catheterization Laboratory Component 381 A. The Pediatric Cardiac Catheterization Laboratory must be co-located within 382 a facility completely equipped to accommodate all aspects of the medical 383 and surgical care of the patient American College of Cardiology Foundation/Society for 385 Cardiovascular Angiography and Interventions Expert Consensus Document 20

21 on Cardiac Catherization Laboratory Standards Update. J Am College Cardiology. 2012; Vol. 59 No B. Cardiac Team 1. Physician in Charge The physician in charge of the procedure must be board-certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics. Pediatric cardiologists either trained in other countries or for any reason not eligible for certification by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics and have completed additional 12 months fellowship in interventional pediatric cardiology may be credentialed as a DOH physician by the Secretary of AHCA or designee, as a special situation after a review and in-depth evaluation by the Pediatric Cardiac Technical Advisory Panel, which recommended such approval. 2. Consulting Physicians In addition to the physician listed above, in interventional cardiac catheterizations, an anesthesiologist and a thoracic surgeon, each with advanced training in the cardiovascular aspects of their specialty, must be immediately available within the facility or in close proximity for 21

22 consultation, assistance, emergency and elective surgical procedures and peri-operative care. 3. Nurse Each laboratory must have a registered nurse, with special training in cardiovascular techniques and in the care of children, as a full time member of the team. This nurse must have special skills in precatheterization evaluation and instruction of the patient and family, care of the patient post-catheterization, and discharge teaching for the patient and family. 4. Cardiovascular Technologist Each laboratory must have a cardiovascular technologist with special training in cardiac catheterization laboratory techniques. 5. Dedicated Trained Cardiovascular Recorder Each laboratory must have a dedicated trained cardiovascular recorder who has no other responsibilities during procedures. 6. Each laboratory must have immediate access to personnel trained in equipment repair and maintenance. 7. Although the above required functions are well defined, it is not necessary for one person to fulfill each separate job category. Well defined adequate 22

23 cross training for other personnel classifications permits 24-hour coverage of essential team functions. 8. All technologists in a cardiovascular laboratory must be certified by the Cardiovascular Credentialing Institute as a Registered Cardiovascular Technologist (RCVT) and licensed by the State of Florida under the Clinical Laboratory law, when applicable. C. Equipment: Radiological, electronic, and computer-based systems are integral components of the equipment in a catheterization laboratory. These systems all require a program of rigorous maintenance and troubleshooting. For pediatric patients, biplane angiography, higher frame rates (30-60 fps), and higher injection rates (up to 40 ml/s) are required to help define abnormal intra-cardiac anatomy. The catheterization laboratory must be able to perform procedures in a patient supported by extracorporeal membrane oxygenation (ECMO) American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catherization Laboratory Standards Update. J Am College Cardiology. 2012; Vol. 59 No D. Electrical Safety and Radiation Protection 23

24 Electrical safety and radiation protection shall be followed in accordance with the manufacturer s recommendations and applicable State and Federal regulations. E. Records 1. Permanent record of real time study must include, at a minimum, video, disk, chart, or digital / electronic recordings. 2. Interpretation and final approval of study reports must be performed by a physician who is board certified in pediatric cardiology. 3. Medical records must be retained for a period of no less than seven (7) years in a secure locked area. F. Initial Evaluation 1. Program Evaluation Review: When a request is received for participation as an AHCA licensed Cardiac Catheterization Laboratory facility, along with attestation of compliance with all these standards, a program evaluation and development review may be requested by the Hospital CEO and the Secretary of AHCA to be performed by members or designees of the PCTAP and scheduled as the final component of the application process. A request for participation shall not be deemed 24

25 complete until the Secretary of AHCA or designee receives the recommendation of the PCTAP. 2. Facility Volume Standards: The minimum annual number of pediatric cardiac catheterizations in a facility requesting to participate as an AHCA Pediatric and Congenital Cardiovascular Center is 150 per facility (with a minimum of 50 interventional) American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catherization Laboratory Standards Update. J Am College Cardiology. 2012; Vol. 59 No Practitioner Volume Standards: The minimum annual number of pediatric cardiac catheterizations performed by each practitioner in a facility requesting to participate as an AHCA licensed Pediatric and Congenital Cardiovascular Center is 50 per year. Practitioners doing interventional procedures must do a minimum of 25 interventional catheterizations per year American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus 25

26 479 Document on Cardiac Catherization Laboratory Standards Update. J Am 480 College Cardiology. 2012; Vol. 59 No Facility Criteria: include all standards in the AHCA Pediatric Cardiac 482 Catheterization Laboratory Component section The Secretary of AHCA or designee considers new facilities for 484 involvement upon the recommendation of the Pediatric Technical 485 Advisory Panel (PCTAP) and all the criteria established above for 486 pediatric cardiac catheterizations. The Secretary of AHCA or designee 487 shall make the final decision on whether or not a facility may continue 488 such entering into an agreement with the Agency. 489 IV. Pediatric and Congenital Cardiac Electrophysiology (EP) Program 490 A Pediatric Cardiac Electrophysiology (EP) Program is an integral part of an 491 AHCA Pediatric and Congenital Cardiovascular Center. The EP program has 492 two main components: (1) An Interventional program in a Pediatric Cardiac 493 Electrophysiology Laboratory and (2) A non-invasive inpatient and outpatient 494 arrhythmia evaluation and management service. 495 An institution participating as an AHCA Pediatric and Congenital 496 Cardiovascular Center, may elect not to participate in both components of 497 these EP Standards. 26

27 All AHCA designated centers must participate in the outpatient arrhythmia evaluation, management, and consultation services. If an institution elects not to participate in the EP interventional program in a pediatric cardiology electrophysiology laboratory, it must have a written format establishing an effective triage to another AHCA EP facility as defined below. Such a protocol must include a formal document signed by the CEO s of both involved institutions and approved by the Secretary of AHCA or designee A. Laboratory Component: The Pediatric Cardiac Electrophysiology Laboratory must be co-located within a facility completely equipped to accommodate all aspects of the medical and surgical care of the pediatric patient. 1. Cardiac Team i) Physician in Charge: The physician in charge of the laboratory must be board-certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics and must be a pediatric electrophysiologist as defined below: 27

28 a) Pediatric Electrophysiologist is a Pediatric Cardiology Board Certified physician, whose primary clinical practice is dedicated to pediatric electrophysiology activities. b) In addition, the individual to be credentialed by DOH as a pediatric electrophysiologist must meet the International Board of Heart Rhythm Examiners (IBHRE) board eligibility criteria by meeting or exceeding the requirements outlined by one or both of the tracks outlined below: International Board of Heart Rhythm Examiners. Eligibility Requirements Policy: IBHRE Board Certification Examination in Cardiac Electrophysiology for the Physician Pediatric Electrophysiologist: Credentials 1) Track 1: Training Completed After July 1, 2005 (i) Successful completion of a pediatric and congenital cardiovascular medicine fellowship program and boardcertified in Pediatric Cardiology by the American Board of Pediatrics. (ii) Successful completion of a minimum of 1 additional year of cardiac electrophysiology training in a pediatric 28

29 electrophysiology fellowship program. The training program must meet the minimum criteria set forth by the task force in pediatric cardiology training. ACCF/AHA/AAP Recommendations for Training in Pediatric Cardiology. A Report of the American College of Cardiology Foundation/American Heart Association/American Committee to Develop Training Recommendations for Pediatric Cardiology) College of Physicians Task Force on Clinical Competence Circulation. 2005; 112: And Recommendations for Advanced Fellowship Training in Clinical Pediatric and Congenital Electrophysiology Walsh, Edward P. et al. Heart Rhythm, Volume 10, Issue 5, (iii)in addition, the electrophysiologist must monitor on a continuing basis at least 30 patients with cardiovascular implanted electronic devices (CIEDs). However, the 29

30 involved pediatric electrophysiologist does not necessarily have to perform all such device implantations 2) Track 2: Training Completed Before July 1, 2005 (i) Pediatric EP applicants completing training prior to July 1, 2005 may qualify either by satisfying Track 1 requirements above, or by demonstrating a minimum level of practice experience consisting of at least 5 years of active pediatric electrophysiology experience, in which the applicant s primary clinical interest is pediatric electrophysiology. The candidate must be actively involved in the management and care of pediatric arrhythmia patients. (ii) Past Experience: (a) A minimum 5 year history of practicing pediatric electrophysiology as his or her primary clinical interest. (b) In that 5 year span, performance of a minimum of 150 EP studies of which at least 90 or 60% of the total must have been catheter ablation procedures. ACCF/AHA/AAP Recommendations for Training in Pediatric Cardiology. A Report of the American College 30

31 of Cardiology Foundation/American Heart Association/American Committee to Develop Training Recommendations for Pediatric Cardiology) College of Physicians Task Force on Clinical Competence Circulation. 2005; 112: And Recommendations for Advanced Fellowship Training in Clinical Pediatric and Congenital Electrophysiology Walsh, Edward P. et al. Heart Rhythm, Volume 10, Issue 5, (c) In addition, the individual must monitor on a continuing basis at least 30 patients with (CIEDs). However, the involved pediatric electrophysiologist does not necessarily have to perform any or all such (CIED) implantations (d) All Pediatric Electrophysiologists must be Board Certified by IBHRE. 31

32 ) Foreign Trainees: Pediatric cardiologists either trained in other countries, or for any other reason not eligible for certification by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics may be credentialed as a DOH physician specializing in electrophysiology by the Surgeon General/Secretary of the Department of Health or designee as a special situation after a review and in-depth evaluation by the Pediatric Cardiac Technical Advisory Panel, which recommended such credentialing. ii) Consulting Physicians: In addition to the physician listed above, during interventional EP cardiac catheterizations, an anesthesiologist and a thoracic surgeon, each with advanced training in the cardiovascular aspects of their specialty, must be immediately available within the facility, or in close proximity, for consultation, assistance, emergency and elective surgical procedures and perioperative care. iii) Nurse: Each laboratory must have a registered nurse, with special training in cardiovascular techniques and in the care of children, as a full time member of the team. This nurse must have special skills in 32

33 pre and post catheterization evaluation, and management. In addition, this individual must be skilled in the coordination of patient and family education and provision of instructions pre and post procedure. iv) Cardiovascular EP Technologist: Each laboratory must have a cardiovascular EP technologist with special training in cardiac EP laboratory techniques. v) Dedicated Trained Cardiovascular EP Recorder: a) Each laboratory must have a dedicated trained cardiovascular EP recorder who has no other responsibilities during such procedures. b) Each laboratory must have immediate access to personnel trained in equipment repair and maintenance. c) Although the above-required functions are well defined, it is not necessary for one person to fulfill each separate job category. Adequate cross training for other personnel classifications permits 24-hour coverage of essential team functions. d) All technologists in a cardiovascular laboratory must be certified by the Cardiovascular Credentialing Institute as a Registered 33

34 Cardiovascular Technologist (RCVT) and licensed by the State of Florida under the Clinical Laboratory law, when applicable Equipment: i) Radiological, electronic, and computer-based systems are integral components of the equipment in a catheterization laboratory. These systems all require a program of rigorous maintenance and troubleshooting. A pediatric electrophysiology laboratory must have: a) Multi Channel EP recording system b) External Defibrillation system c) Cardiopulmonary monitoring system d) Radiofrequency Energy Source e) It is strongly recommended that Pediatric Electrophysiology laboratories also have: 1) 3 Dimensional Mapping System 2) Cryo ablation System ii) Electrical Safety and Radiation Protection: Electrical safety and radiation protection shall be followed in accordance with the manufacturer s recommendations and applicable State and Federal regulations. 3. Records 34

35 i) Permanent record of real time study must include, at a minimum, video, disk, chart, or digital / electronic recordings. ii) Interpretation and final approval of such EP study reports must be performed by a physician who is board certified in pediatric cardiology and meets the standards to be qualified as a pediatric electrophysiologist, as defined previously. iii) Medical records must be retained for a period of no less than seven (7) years in a secure locked area. 4. Initial Evaluation i) Program Evaluation and Development Review: When a request is received for participation as an AHCA Pediatric Cardiac Electrophysiology Laboratory facility, along with attestation of compliance with all these standards, a program evaluation and development review by members or designees of the Pediatric Cardiac Technical Advisory Panel may be scheduled as the final component of the application process at the request of the Hospital CEO and the Secretary of AHCA. An application shall not be deemed complete until the Secretary of AHCA or designee receives the recommendation of the Pediatric Cardiac Technical Advisory Panel. ii) Medical Records Review: 35

36 a) A minimum of 12 consecutive pediatric cardiac catheterization electrophysiologic studies within a year must be available to warrant initial inspection of any facility. b) A minimum of 7 consecutive pediatric implantable device insertions (pacemakers and / or Implantable Cardioverter Defibrillators) studies within a year must be available to warrant initial inspection of any facility. iii) Facility Volume Standards: Facilities shall be evaluated independently for two separate areas of expertise within a pediatric electrophysiology program: EP studies with ablations and device insertions. a) EP studies and ablation: The minimum annual number of pediatric electrophysiologic studies in an applicant facility is recommended to be at least 30 per facility with a minimum of 18 ablations, or 60% of the total number of studies per year. Source: PACES SURVEY, 2012 b) CIED implantations: Pacemaker and Implantable - Cardioverter defibrillators (ICD) insertions. The minimum number of combined CIED implantations (pacemakers and ICD s) in an applicant facility is recommended to be at least 10 per year. For the purpose of facility 36

37 volume standards, CIED insertions may be performed by either a credentialed AHCA pediatric and congenital cardiovascular surgeon and /or a credentialed DOH pediatric electrophysiologist. iv) Practitioner Volume Standards: a) Pediatric electrophysiologists shall be evaluated independently for two separate areas of expertise within a pediatric electrophysiology program: EP studies with ablations and CIED Insertions b) A practitioner may choose to be credentialed to perform EP studies / ablations and CIED insertions, or both. 1) The minimum annual number of pediatric cardiac electrophysiologic studies performed by each practitioner in an applicant facility is recommended to be at least 30 per year, of which at least 18, or 60% of the total number of studies per year, are catheter ablation procedures. 2) If the Pediatric Electrophysiologist is the physician performing CIED insertions, the minimum annual number of pediatric device implants (pacemaker and/ or ICD) performed by each practitioner in an applicant facility is recommended to be at least 10 per year. 37

38 Electrophysiology Society Clinical Competency Statement: Training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients. Developed in collaboration with the American College of Cardiology and the American Heart Association. J. Philip Saul, MD, FHRS, Victoria L. Vetter, MD, Heart Rhythm, Vol 5, No 6, June 2008 (i) Practitioners whose volume falls below 10 per year must then demonstrate that they have an established working relationship with either a credentialed DOH pediatric and congenital cardiovascular surgeon or a credentialed DOH pediatric electrophysiologist performing CIED implants or an adult electrophysiologist trained in CIED implantation, and demonstrate that such physicians are available in case they are needed. v) Outcomes Standards: The members of the AHCA PCTAP Cardiac Technical Advisory Panel s EP Task Force will develop and recommend that all AHCA Cardiac Centers participate in a database into which the involved EP physicians 38

39 would report the outcomes of their EP Studies and device insertions. Such database recommendations will be submitted to the AHCA PCTAP Cardiac Technical Advisory Panel and implemented if the Panel supports such recommendations. a) Outcomes Reporting Standards (i) All Electrophysiologic studies must be reported to IMPACT i. Procedural data must be entered in the report within a week of the procedure. The data shall be submitted to the IMPACT registry at intervals no less frequent than quarterly. ii. Long term success and complication data shall be reported at IMPACT-between 3 months and 12 months of the procedure date (ii) Endocardial Device Insertion Procedures. Acceptable success and complication rates are not yet defined in the pediatric population. However, outcomes will be reported in databases currently under development for outcomes analysis. 39

40 (iii)epicardial Device Insertion procedures are considered cardiac surgeries and outcomes evaluated in the context of the involved cardiovascular surgical program. b) Outcomes Standards- Second Phase: 1) When national outcome standards are defined, they will be submitted to the PCTAP as the new outcome standards for Florida AHCA pediatric electrophysiology centers. 2) Once procedural success and complication rates are measured and published, the PCTAP Task force shall recommend that acceptable program and or practitioner volume and outcomes are within two standard deviations from the national mean. vi) Facility Criteria: Includes all standards in the AHCA Pediatric Cardiac Catheterization Laboratory Component section. 5. Re-evaluation of AHCA Centers: a) Program Evaluation and Development Review: Each AHCA Pediatric Cardiac Electrophysiology Laboratory Facility may be evaluated on-site by members or designees of the Pediatric Cardiac Technical Advisory Panel at a minimum of once every three (3) years at the request of the hospital CEO and the Secretary of AHCA. The re-evaluation process is not complete until the 40

41 Secretary of AHCA or designee receives the recommendations of the Pediatric Cardiac Technical Advisory Panel. b) Medical Record Review: A minimum of 12 consecutive pediatric cardiac electrophysiologic studies must be available within a specified time period for review at the time of the re-evaluation. Volume Standards are as follows: c) Facility Volume Standards: The minimum annual number of pediatric electrophysiologic studies in an applicant facility is recommended to be at least 30 per facility with a minimum of 18 ablations, or 60% of the total number of studies per year. d) Practitioner Volume Standards: (i) By the first or subsequent three-year review, the minimum annual number of pediatric cardiac electrophysiologic studies performed by each practitioner in an applicant facility is recommended to be at least 30 per year, of which at least 18, or 60% of the total number of studies per year are catheter ablation procedures. (ii) Pediatric electrophysiologists performing CIED implantations are recommended to perform at least 10 CIED implantation procedures per year. 41

42 e) During the initial phase of the development of outcomes standards, defined in Section III.A.4.v) a), EP facilities will be evaluated by examining their completeness of data submission. During this initial phase, the primary evaluative assessment will be procedural outcomes as deemed acceptable based on existing literature. f) The second phase of outcomes evaluation, Section III.A.4.v)b), will be completed once national standards are derived IMPACT- into which all Florida EP programs are expected to submit their data outcomes, then the facility will be reviewed by the Pediatric Cardiac Technical Advisory Panel which may recommend that the facility be placed on probationary status for one year. Probationary status may be extended one (1) additional year if the facility documents a positive trend in meeting the outcomes standard. If the facility has not achieved the acceptable outcomes standard at the end of the second year of probationary status, the facility shall be provided with a notice of intent to end the agreement between the AHCA Pediatric and Congenital Cardiovascular Center and the Agency. After a 90 day transition period, the facility will receive a formal notice to end the agreement between the AHCA Pediatric and Congenital Cardiovascular Center and the Agency. B. Outpatient Clinic Component 42

43 Facility Criteria: include all standards, as outlined in the outpatient clinic section. In addition, an outpatient electrophysiology program must have the following components: i) Personnel: a) The physician in charge of this clinic is to be board eligible or board certified by the IBHRE and Basic Life Support and have special expertise in arrhythmias and device management. The physician must be IBHRE certified within 5 years of becoming Board eligible. b) The involved nurse/technician is to have special expertise in CIED management and be certified in both Basic Life Support and Pediatric Advanced Life Support. ii) Device Management: Pacemaker, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) device monitoring is performed by combining both in-clinic and remote (home) monitoring. Criteria for intervals for CIED follow-up must recognize that the complexity of the underlying heart disease dictates the intervals for such surveillance. A reasonable guide for inclinic monitoring is as follows: 43

44 a) Antibradycardia devices: At a minimum, the patient will be seen in the clinic one week and then 3 months post implant. Then the patient should be seen no less frequently than annually as long as clinic visits are supplemented by remote monitoring from home no less frequently than every three months, and more frequently as may be clinically indicated. Complexity of the issues managed or CIED related issues may require a more intensive and frequent monitoring schedule. Evaluation of surgical site may be performed by physicians in the patient s local community when deemed appropriate. b) ICD and CRT devices: At a minimum, the patient will be seen in the clinic within one week and then 3 months post implant. Then the patient should be seen no less frequently than bi-annually as long as clinic visits are supplemented by remote monitoring from home no less frequently than every three months, and more frequently as may be clinically indicated. Complexity of the issues managed; or device related issues, may require a more intensive and frequent monitoring schedule. Evaluation of surgical site may 44