Riel: Scott Governor John H. In, State Surgeon General 8. Secretary To protect. promote improve the health of all people in Florida through integrated state. county community efforts. To be the Healthiest State in the Nation June 26, 2014 Davide M. Carbone Michael Black, MD Chief Executive Of?cer Director, Pediatric Cardiovascular Surgery Palm Beach Children's Hospital Palm Beach Children?s Hospital St. Ma ?5 Medical Center St. Ma ?3 Medical Center 901 45 Street 901 45 Street West Palm Beach, FL 33407 West Palm Beach, FL 33407 Dear Mr. Carbone and Dr. Black: Thank you very much for voluntarily accepting and participating in the program evaluation and development site visit of the Palm Beach Children's Hospital Pediatric Cardiac Program at St. Mary's Medical Center on April 8, 2014. We recognize your commitment to caring for Florida?s children. Enclosed are the reports generated by the participants of the site visit team. We hape each report provides additional guidance, as St. Mary's Medical Center continues to devel0p its Congenital Heart Program. Any Opinions expressed within the enclosed reports that are outside the stated objectives of the program evaluation are solely those of that team member, not the Florida Department of Health. If you have questions regarding those opinions, please contact that individual. The Department was pleased that all issues related to St. Mary's Certi?cate of Need were put to rest during the program evaluation. The October 6, 2009, modi?cation of the CON issued by the Agency for Health Care Administration to the St. Mary?s Medical Center Pediatric Open Heart Program, resolves any issues related to compliance with the initial CON application requirements. Thank you for your willingness to bring closure to this issue. The leadership and staff of CMS look forward to future collaboration with your institution's Pediatric Cardiovascular Program on CMS quality improvement initiatives. If you have any questions, please contact or at (850) 245-4200 extension 2247. Sin Philip, MD, MPH Deputy Secretary for Health Deputy State Health Of?cer for CMS Enclosures cc: Charlotte M. Curtis, RN, BSN, CPM, CMS Interim Director CMS Cardiac Technical Advisory Panel Members Christine Smith, RN, BSN, CCRN, C-NPT, PICU Cardiac Clinical Coordinator Don W. Chester, Assistant Administrator J. Curt Fudge, MD, Pediatric Cardiologist at UF Congenital Heart Center in Gainesville I'Iorlula Department oi mJlorklu?on?hm Division of Children?s Medical Services - Bureau of Network Operations 4052 Bald Cypress Way. Bin A06 - Tallahassee. FL 32399?1701 PHONE: 850345-4200 FAX 850l'488-3813 YOUTUBE: ltdoh Nemours Alfred I duPont Hospital for Children Wilmington. Delaware Nernours Dyslexia Initiative Nemours Center for Children's Health Media Nemours Children's Clinic Jacksonville. Florida Orlando. Florida Pensacola. Florida Wilmington Delaware Nelnours Health 8? Prevention Services Nernours l-lealth Clinic Wilmington. Delaware Nemours Mansion 8. Gardens Nernours Partnership for Children's Health Nemours Pediatrics Nemeurserg Kidsl?lealth Org PedsEducationorg Nemours Children?s Clinic Children's Medical Services Program Evaluation and Development Peer Review Palm Beach Children's Heepital (St. Mary?s Hospital) West Palm Beach, Florida 4/8114 Attendees: Mlliam B. Blanchard, MD, FAAP. FACC, FAHA, Associate Statewide Pediatric Cardiology Consultant, Lisa Rocheteau, Assistant Administrator, Patti Patrick. Director of Business Development, W. Jeffrey Davis, DO, FACEP, Chief Medical O?icer, Donna Small, RN, BSN, MBA, Chief Nursing Of?cer, Davide M. Carbone, FACHE, Chief Executive Of?cer, Don Chester, Assistant Administrator, Government and Community Relations, Chrishonda Jenkins, RN, BSN. Nursing Consultant, Kelli Stannard, RN, BSN. Specialty Program Director 1) 2) 3) When does St. Mary's Hospital predict the surgical case volume will be 100 cases in a twelve month period? Answer/Oman: Mr. Carbone is confident that given the birth statistics for their county (14,300 births this past year), there are more than adequate number of congenital heart cases currently born in the region. The dif?culties in growing program volume require changing traditional referral pattems as the community becomes faniliar with Dr. Black?s availability and surgical outcomes. it is anticipated that more patients in the Palm Beach area will be referred to the program in the future. Mention was made that there are cunent discussions amongst the CMS CTAP to increase required number of cases for new programs applying for CMS Cardiac Center designation be increased to 150 per year. The staff of St. Mary's hope we will focus on outcomes rather than volume. Question: Are there any format agreements between St. Mary?s and University of Miami's School of Medicine regarding af?liation and surgical backup when Dr. Black is not available? During the CON application process St. Mary's entered into discussions with the University of Miami and their Department of Surgery and with Dr. Rosencrantz of their Pediatric Cardiac Surgery program. The intent was to explore a mutually beneficial relationship for both programs and to provide back-up for their new pediatric cardiac surgeon. These discussions concluded without an agreement being reached. After CON approval and after recruiting their new pediatric cardiac surgeon (Dr. Black) to lead their program, St Mary?s also had discussions with Dr and the team at Joe DiMaggio Children's Hospital, but JDCH decided they did not want to enter into any format or informal relationsz with Since Dr. Burke and his team at Miami Children's Hospital strongly opposed the SMMC CON application, and after the CON approval, continued to demonstrate anger and anxiety over SMMC's new program, SMMC assumed contacting them for a possible af?liation would not be productive. Therefore SMMC did not approach Miami Children?s Hospital and MCH did not approach SMMC. Mr. Carbone stated an af?liation with an existing local program may have some bene?ts. but was get an intentional condition of their CON, and that was clari?ed by AHCA on October 6, 2009. St. Mary's remains very open to an af?liation with an established Pediatric Cardiac Surgical program and they continue to explore Options to develop an af?liation and back-up coverage and support Question: Does St. Mary's Hospital plan to apply for CON to do cardiac transplantation? Am There are no plans to apply for cardiac transplantation. Current congenital heart program is in its early beginnings and they do not see a need to offer 4) 5) 5) 7) cardiac transplantation any time in the future given the cunent existing programs at University of Miami and Joe DiMaggio Children's Heepital. What is the status of implementation of neonatal pulse oximetry screening to detect congenital heart disease? AnswerIDiscussion: Palm Beach Children's Hospital has been routinely screening all newborn infants in their nursery by pulse oximetry for greater than two years. When newborn screening forms are updated they will supply data to the State of Florida for all of their patients. Question: What is the format for handling adults with congenital heart disease? Answer/Discussion: There are Currently nine pediatric cardiologists with staff privileges at Palm Beach Children's Hospital. Six of these cardiologists are employed by Pediatrix Medical Group, three are employed by a local private group under Medical Services (KMS). individuals within these groups all continue to see adult age patients over 18 with congenital heart disease. Cardiac catheterization and interventional catheterization services continue to be offered by Dr. Jay Chandar and Dr. Michael Black has experience in surgery for adults with congenital heart disease. Additionally, some adult cardiologists do follow patients with congenital heart disease. Staff is planning to have an integrated adult congenital heart disease clinic in the future. Electrophysiology issues are handled by adult electrophysiologists. Children with congenital heart disease and cardiac disorders, however, are likely to be referred to University of Miami or Joe DiMaggio Children's Hospital programs or Miami Children's Hospital. Application is currently is in progress with the Adult Congenital Heart Association. Question: Is St. Mary's involved in data submission? A) Cardiac surgical data to STS currently ongoing B) Currently are ?lling out paper work for submission of data to the cardiac anesthesia module of STS C) Cardiac catheterization data to - not in progress but plan to pursue D) E-P procedures to since no E-P studies are done in children at Palm Beach Children?s Hospital, they will not participate in MAP-IT database until a program develops Question: Currently there are four pediatric cardiovascular center facilities in the immediate South Florida area. Will there be enough patients to meet surgical volume requirements? Answer/Discussion: Cunent census data indicate that there are 14,300 live births in Palm Beach County, 45% of which are sponsored by Florida Medicaid. It is envisioned that this provides a large number of children born with congenital heart defects. The general service area for St. Mary's NICU and Pediatric referral services goes north as far as lndian River County. Being the only hospital to provide these services between Ft Lauderdale and Orlando, having a program in this area serves those patients who many times are unable to or are inconvenienced by having to travel several counties south to Broward or Dade Counties. This is especially true for those families of Medicaid patients; which is the largest portion of Pediatric patients at St Mary's and their Palm Beach Children's Hospital. The primary problem has to do with traditional referral patterns. Currently the six cardiologists with Pediatrix have practices in Ft. Lauderdale, Boca Raton and Palm Beach at other centers. They may refer their cardiac patients to the three other existing pediatric cardiac CMS programs. The three cardiologists with KMS Group mainly practice at Palm Beach Children's Hospital. In addition, six matemal fetal medicine specialists are on staff at St. Mary?s Medical Center and direct their patients identi?ed in uretero to the program at St. Mary's. St. Mary?s remains optimistic that they will develop a clinical partnership with one of the three other existing pediatric congenital heart programs in South Florida in order to accommodate the volume of patients generated from Palm Beach County. 3) 9) Question: Are there plans to recmit a second onsite pediatric cardiovascular surgeon. AnswerlDiscussion: Currently the program is in its early development. It is anticipated when cardiac surgical volume increases, a second onsite pediatric cardiac surgeon will be recruited to assist Dr. Black, or coverage will be arranged through an af?liation with another program. Statement: CMS staff acknowledge that Dr. Michael Black has been attending the telephone meetings of the CMS CTAP as well as their legislative representative. We acknowledged the valuable input from Dr. Black and encouraged his continued congenial participation in the meetings of the committee. 10) Question: Are there existing CMS clinics affiliated with St. Mary's Medical Center? Answer/Discussion: Space is currently leased to an existing CMS clinic on the campus of St. Mary?s Medical Center. Currently two buildings are leased. 11) Question: Would St. Mary's Medical Center leadership consider sending a formal report to the CMS program of?ce regarding the value of this site visit along with suggestions and further foedback for improvement of such visits? AnswerfDiscussion: Mr. Carbone stated that, once they receive our report, they would be happy to provide us feedback on the whole process. Recommendations: Based on our Administrative review of it is apparent that the administration of St. Mary's Hospital and Palm Beach Children?s Hospital have invested considerable ?nancial resources in the initial creation and development of a Pediatric Congenital Heart Program. In order for future growth of the program to progress, I would emphasize the following suggestions: 1) 2) 3) Af?liation with an existing CMS Cardiac Program could accrue positive bene?t to St. Mary?s nascent program in both cross coverage for cardiac surgery and interventional catheten'zation, maintaining competency of physician and nursing teams and training of allied support personnel. Geographically, Joe DiMaggio Children's Hospital, Miami Children's Hospital or the University of Miami are the most logical options. However, a longer distance af?liation with programs in Central or North Central Florida with scheduled staff commuting both ways are also possible. A phased approach to performance of increasing case complexity is not just desirable. but recommended by safety and quality performance standards. While Dr. Black has excellent training and clinical experience with complex congenital conditions, outcomes depend on the carefully choreographed performance of an integrated surgical team including lntensivists, pediatric cardiologists, nursing staff, respiratory therapists and complex post operative care protocols. Given the existence of two pediatric cardiology groups practicing at St. Mary's, the potential exists for problems in coverage for post operative patients. While the pediatric intensive care physicians are on?site and involved in the minute to minute care of these often very sick patients, pediatric cardiology needs to be highly involved and available for the care of these patients. Hand off/Check out protocols must be clear to the nursing staff as to which cardiology group is following their patient, who is on call, and with reassurances that the involved individuals are within a reasonable commute to the (or preferable in- house). The hospital does have lntensivists in-house 24l'r?l365, and Dr. Black routinely spends the ?rst 24 hours post-surgery in-house with his patients. 4) Only alter the existing systems are in place to insure experience, precise communications, and availability of the surgical team. should the program advance to the next level of surgical case complexity in a graduated step wise fashion. I would like to thank the administrative team at St. Mary's for their hospitality and willingness to participate in the advisory review process. QEMMD William B. Blanchard, MD, FAAP, FACC, FAHA Associate Sta?ewide Pediatric Cardiology Consultant Children's Medical Service A CONGENITAL HEART CENTER PO Box 100297 Gainesville, FL 32610-0297 Telephone: (352) 273?5422 Fax: (352) 273- 5927 May 15, 2014 Charlotte M. Curtis, RN, BSN, CPM Interim Director, Division of Children?s Medical Services Florida Department of Health 4052 Bald Cypress Way, Bin Tallahassee, FL 32399-1707 RE: Program Evaluation and Development Peer Review Palm Beach Children?s HOSpital Pediatric Cardiovascular Program West Palm Beach, Florida April 8, 2014 Dear Ms. Curtis: On April 8, 2014 i had the pleasure and privilege of representing the State of Florida Children?s Medical Services Pediatric Cardiovascular Review Committee at the site visit of the pediatric cardiovascular program at Palm Beach Children?s Hospital at St. Mary?s Medical Center in West Palm Beach, FL. The visit was performed in conjunction with Dr. Jeffrey Jacobs, Dr. William Blanchard, Dr. Ira Gessner, Dr. Jorge McCormack, Ms. Kelli Stannard, and Ms. Chrishonda Jenkins. Numerous administrators, physicians, and staff of the pediatric cardiovascular program at Palm Beach Children?s Hospital provided an overview of the program and were available to answer questions throughout our visit. My focus during the visit was the pediatric cardiac catheterization program and this letter serves as a summary of my review. Dr. Jay Chandar has been the director of the pediatric cardiac catheterization program at Palm Beach Children?s HOSpital since 20 I 2. His expertise in the ?eld of pediatric cardiology and congenital cardiac catheterization span more than two decades; therefore, he brings a great deal of experience to the program. Dr. Chandar and Mr. Christopher Petrides, the nurse manager for the pediatric cardiac catheterization laboratory, provided a complete overview of the catheterization program and were available to answer my questions throughout the day. The pediatric catheterization facilities and team include a state-of-the-art GB biplane suite and a team which is shared with the neuro?interventional group at St. Mary?s Medical Center. The laboratory has all of the hemodynamic and imaging capabilities necessary to perform complex pediatric diagnostic and interventional procedures. Although many members of the catheterization team are shared with the neuro-interventional group, both nursing and cardiovascular technology staff have specialized training in cardiac catheterization techniques. Their experience is limited only by the volume of pediatric cardiovascular cases performed. As anticipated with a new and developing program, the case volume in 20 3 was low and consisted of thirty-?ve total procedures. The relative number of interventional RE: Program Evaluation and Development Peer Review Palm Beach Children?s Hospital Pediatric Cardiovascular Program West Palm Beach, Florida April 8, 2014 catheterizations performed was quite high at thirty-three suggesting the effective use of noninvasive imaging for diagnostic purposes with a focus on utilizing cardiac catheterization at a therapeutic treaunent tool. In addition to assessing both the catheterization facilities and team, I had the opportunity to review a total of 10 consecutive cardiac catheterization cases which included both diagnostic and interventional cases. I found the medical records to be complete and without de?ciencies. Of note, the program does not currently participate in the American College of Cardiology NCDR IMPACT Registry. My assessment of the pediatric cardiac catheterization program at Palm Beach Children?s Hospital with regard to the published CMS guidelines is as follows: The pediatric cardiac catheterization program met the following published CMS guidelines: The pediatric cardiac catheterization laboratory is co-located within a facility completely equipped to accommodate all aspects of the medical and surgical care of the patient. Dr. Chandar is a Board Certi?ed Pediatric Cardiologist Dr. Chandar met the minimum practitioner requirement of 25 interventional procedures annually at Palm Beach Children?s Hospital. An anesthesiologist and thoracic surgeon with advanced training in the cardiovascular aspects of their specialty are immediately available within the facility for consultation, assistance, emergent and elective surgical procedures and peri-operative care. There is a full-time registered nurse with special training in cardiovascular techniques overall care of children, including special skills in pre-catheterization evaluation and instruction, care of the patient post-oath, and discharge teaching for the patient and family There is a cardiovascular technologist with special training in cardiac catheterization laboratory techniques. There is a dedicated trained cardiovascular recorder who has no other responsibilities during procedures. All technologists in the cardiovascular laboratory are certi?ed by the Cardiovascular Credentialing institute as a Registered Cardiovascular Technologists or licensed by the State of Florida under clinical laboratory law, when applicable. Technologists are radiologic technologist certi?ed by the American Registry of Radiologic Technologists in cardiac-interventional radiography and/or radiography. Personnel trained in equipment repair and maintenance are immediately available to the lab. The laboratory has biplane ?uoroscopy and appropriate capabilities for performing pediatric cardiac catheterizations. Electrical and radiation protection guidelines are followed. Medical recOrds documenting cardiac catheterizations include the appropriate hemodynamic recordings, images and reports and these records are retained for a period of at least seven years RE: Program Evaluation and Development Peer Review Palm Beach Children?s Hospital Pediatric Cardiovascular Program West Palm Beach, Florida April 8, 2014 The pediatric cardiac catheterization program did not meet the following published CMS guidelines: 0 One hundred pediatric cardiac cadreterizations are not performed annually (applicant facility requirement compared to the minimum annual requirement of one hundred ?fty cases for a CMS approved facility) 0 Fifty interventional cardiac catheterizations are not performed annually 0 Dr. Chandar did not meet the minimum practitioner requirement of fifty cardiac catheterizations per year at Palm Beach Children?s Hospital. Dr. Chandar?s cardiac catheterization case volume at facilities other that Palm Beach Children?s Hospital was not part of my review during this visit; however, I anticipate that his total case volume exceeds ?fty catheterizations annually. There were several observations that I made during my visit which are not addressed by the current CMS guidelines but I feel are worthy of mention. These pertain to the coverage and availability of a pediatric interventions] cardiologist for both routine and emergent cardiac catheterization procedures. Dr. Chandar is currently the only pediatric interventions! cardiologist with privileges to perform pediatric cardiac catheterizations at Palm Beach Children?s Hospital. This creates a void in coverage for both routine and emergent cardiac catheterization cases when he is not available. In addition, Dr. Chandar?s primary practice is located approximately sixty miles ?'om Palm Beach Children?s Hospital; therefore, his immediate availability is somewhat limited by geographic distance. In order to provide comprehensive cardiovascular care to this complex patient population, it is important to provide continuous and readily available support from a pediatric catheterization team. My recommendation would be that the pediatric cardiovascular program at Palm Beach Children's Hospital evaluate its current coverage for both routine and emergent cardiac catheterization cases to ensure that it is suf?cient, especially in cases were Dr. Chandar is not available. in summary, the pediatric cardiac catheterization program at Palm Beach Children?s Hospital led by the direction of Dr. Jay Chandar has provided excellent care to the patients that it serves. Although it does not meet all of the current published CMS guidelines for a pediatric cardiac catheterization program, its de?ciencies in this area are all related to the lower volume of cases that it performs. Further growth of the cardiovascular program will be necessary for the catheterization program to meet the current CMS standards. Increases in case volume would not only allow the program to ?rl?ll current CMS standards, but it would provide invaluable experience to all members of the catheterization team and allow the development of a more specialized pediatric catheterization team. Once again, thank you for the opportunity to represent the State of Florida Children?s Medical Services Cardiovascular Review Committee at the site visit for Palm Beach Chi ldren?s HOSpital. Please do not hesitate to contact me with any questions that you may have regarding my review. Sincerely, m. a James Curtis Fudge, MD., MHS Assistant Professor, Pediatric Cardiology Director, Congenital Cardiac Catheterization Program UF Health Congenital Heart Center IJCF NTER CONGENITAL HEART CE POBOX 100297 Gainesvilte, FL 32610-0297 Telephone: (352)273-5422 Fax: (352) 273?5927 Palm Beach Children?s Hospital Site Visit April 8, 2-014 participated in a site visit to Palm Beach Children?s Hospital at St. Mary?s Medical Center in West Palm Beach on April 8, 2014, for the purpose of providing an external evaluation and recommendations for their program in congenital heart disease. The site visit was organized by the Division of Children?s Medical Services and carried out by the CMS Cardiac Technical Advisory Panel. Participants in the site visit, including DCMS staff, physician members of the Cardiac Technical Advisory Panel and representatives of St. Mary?s Medical Center are well cataloged in the reports of others on this site visit and, with one exception, I will not repeat the names here. My interaction during the patient information review component of the site review took place with the assistance of Dr. Emmanouil Tsounias. Dr. Tsounias remained present throughout my review and was quite helpful in answering questions and providing supplemental information. In this report] do not intend to include comments regarding the presentations of St. Mary?s Medical Center administrative and medical staff nor will I discuss the physical plant, as these aspects of our site visit are, I feel sure, well documented by others. My review did not accomplish the objectives that I anticipated. I intended to review 25 consecutive out-patient evaluations of new patients seen by pediatric cardiology physicians associated with Palm Beach Children?s HOSpital pediatric cardiology program. Because of lack ofclarity in communicating this request, no doubt due in some, or major, part to my failure to make my requirement clear, St. Mary?s Medical Center staff provided me with 25 consecutive echocardiogram reports. I reviewed each of these and the remainder of this report refers to this material. As mentioned, Dr. Tsounias, one of the staff echocardiographers, was present or immediately available at all times. I am not an echocardiographer. 1 think, however, that my experience and familiarity with the ?eld allows me to provide this commentary. I reviewed only reports; no actual echocardiograms were provided but St. Mary?s staff offered to access the studies if I requested. The time available to accomplish my review (as discussed below) was not adequate for this, nor did I want to do so. The echocardiogram reports are uniformly inadequate. They are short, provide primarily only descriptive comments and contain no quantitative information. There is no reporting of chamber size, functional assessment, etc. Some reports are confusing and others contain recommendations for ?rrther evaluation that I consider inappropriate. A few examples should suf?ce. A baby with the diagnosis on the report of persistent pulmonary hypertension had several echos read by Dr. P. Sherron. None contained information regarding right ventricular or pulmonary artery pressure. A later echo, read by Dr. S. Chandrasekhar, similarly included no data but concluded that the study showed ?no pulmonary hypertension?. A four month old infant underwent echo for ?abnormal clinical ?ndings? not further described. The echo was reported as normal. An echo was done with ?Indication 42093 75; echo complete". The report states normal. An echo on patient LE. on 1/4/13, with the indication aortic valve replacement? was reported by Dr. Sherron as ?normal study". Another echo on the same patient on 4/8/13, reported by Dr. R. Dubois, indicates ?bicuspid aortic valve. . .moderate aortic regurgitation that did not change signi?cantly post angiOplasty?. Dr. Sherron?s report is, at the least, confusing. A newbom, whose prenatal echo suggested abnormality, following birth demonstrated normal physical examination, normal electrocardiogram and normal echocardiogram with the expected ?nding of a patent foramen ovale. The report recommends ?follow up in our of?ce at around 3 months closed.? Every newborn has a PFO. No justi?cation exists for this recommendation. 0f most concern to me regarding the structure of the echo reports was the explanation given to me by Dr. Tsounias. In acknowledging the reports? inadequacies, he stated that the echocardiogram report format was established many years ago by the chief echo technician and that, with the support of the physician director (not a pediatric cardiologist), no changes could be made. The reading physician can dictate additional information if they want to do so, (I found almost none of this) but the format of the report cannot be changed. I think that the American Society of Echocardiography would not approve. While Dr. Tsounias told me that he is the primary echocardiographer for the program, data listed for calendar year 2013 suggests to me a problem in this regard. The program did 1315 transthoracic studies; Dr. Tsounias reported 27% of these. Seven other physicians reported studies, ranging from less than 1% to 14%. 0f further concern, the program did 20 transesophageal studies and these were reported by 5 physicians, two of whom, including Dr. Tsounias, reported only one. The program reported 15 fetal echocardiograms, reported by 6 physicians, ranging in number ?om one (two physicians) to 5 reported by Dr. Tsounias. I think that quality control cannot be assured by this spread of reporting responsibility, and I do not think that this structure will allow the pediatric cardiology echocardiography laboratory to achieve societal approval. 1 think it noteworthy that, with the exception of two patients with established congenital heart defects, and not counting PFOs, almost all of the echocardiograms reported normal ?ndings. While trying to gain information about the practice habits of the pediatric cardiologists, I asked Dr. Tsounias about the likelihood that a new patient, referred for evaluation, would receive an echocardiogram. He said that all do; and he seemed surprised that I would suggest otherwise. I am quite aware that the large majority of pediatric cardiologists in Florida, including those at my own program, accomplish echocardiograms on almost all new patients referred for any reason, including the most common, an heart murmur. I ?nd this behavior unsupportable on scienti?c grounds and reprehensible in its costs. Those who reference studies that physicians? skills in clinical diagnosis of a heart murmur are inadequate fail to mention that these studies do not involve pediatric cardiologists. A board certi?ed pediatric cardiologist who cannot diagnose an innocent murmur as such by physical examination alone in over 90% of patients does not belong in clinical practice. This report does not represent an assessment of the clinical program in pediatric cardiology at Palm Beach Children?s Hospital at St. Mary?s Medical Center. If the program applies for DCMS approval I would be pleased to revisit the program and, with appropriate clinical data, evaluate it. I offer one ?nal comment. The time allotted for chart review is not suf?cient to accomplish what I think is an adequate review of a clinical program. The agenda for this site review provided 1 3/5: hours for chart reviews. My experience in accomplishing site reviews at other programs indicates that one ot properly evaluate 25 charts in that amount of time. Ira H. Gessner, MD. Professor, Department of Pediatrics Division of Cardiology UF Health Congenital Heart Center Pediatric Cardiology Associates IN AFFILIATION WITH I Congenital Heart Institute of Florida Frances M. Arrillaga, MD Javier Gonzalez, MD Stephanie A. Kurtz, MD Daniel E. McKenna, MD Alfred Asante-Korang. MD James G. Henry, MD Michael LaCorte, MD Jeremy Ringewald, MD Anna Bel-nus, MD James C. Huhta, MD Richard M. Martinez, MD Elsa J. Suh, MD Jorge M. Giraud, MD J. Blaine John, MD Jorge MoConnack, MD Kristin Rosenberg. ARNP Amanda Pavlock, ARNP May 2,2014 Charlotte M. Curtis, RN, BSN, CPM Interim Director Division of Children's Medical Services Florida Department of Health 4052 Bald Cypress Way, Bin Tallahassee, FL 32399?1707 Dear Ms. Curtis: The Program Evaluation and Development Peer Review of the Pediatric Cardiovascular Center Program at St Mary's Medical Center Palm Beach Children?s HOSpital was completed on April 8, 2014. The CTAP review team consisted of Drs. William Blanchard, Ira H. Gessner, J. Curt Fudge, Jeffrey Jacobs and myself. We were also assisted by Kelli Stannard, RN, BSN and Chrishonda Jenkins, RN, BSN of the CMS office. The main spokespersons for the hospital were Davide M. Carbone, CEO, St. Mary's Medical Center and Dr. Michael Black, Director, Pediatric Cardiothoracic Surgery, Palm Beach Children's Hospital. In addition, we met with numerous members of the Hospital Administration including the chief of medical staff. Upon completion of the initial records review, we toured the operating room, Cath Lab and Intensive Care Units. At the time of Our visit, there were no pediatric cardiac procedures being performed and there were no cardiac patients in the ICU. Comprehensive Cardiology for the Children of Florida 1 601 5th Street South at 711, St. Petersburg, FL, 33701 Tel: 727-322-4830 Fax: 727-821-2461 3003 w. Dr. ALL. King Jr. Blvd, 3rd Floor Tampa FL, 33607 Tel: 813-554-3701 Fax: 813-870-0100 Additional Of?ces in Brandon, Clearwaoer, Ft. Myers/Bonita Springs, N. Tempe, Sarasota, St. Petersburg, and Tampa Visit us at In this site visit, I was assigned to evaluate the electrophysiology services rendered by the cardiac program and, most importantly, make suggestions that would'help this developing program comprehensive quality care including management and eventually be_in concert with other CMS approved Pediatric EP programs. Historically at St Mary?s, the pediatric cardiologists have managed simple problems themselves, as is standard of care for most outpatient cardiology practices. When a complex electrophysiology problem is encountered, the cardiologists will then seek consultation with one of the three EP programs in SE Florida and less frequently, Orlando or Tampa Bay. At this point there is no formal or informal affiliation with any of these other programs. That pattern of practice was perfectly adequate for a non surgical pediatric cardiology program. However, upon initiation of a cardiac surgical program, the demands on this pediatric cardiology program have substantially increased. As the number and complexity of surgical cases kept ?in house? increases, so will the electrophysiologic needs of these patients. are one of the most common post operative complications. The team needs to be prepared, anticipate and expeditiously manage in the postoperative setting. As an integral part of these anticipated needs, electrophysiology consultation must be readily, reliably and consistently available. The recently approved Pediatric EP Standards require that all CMS cardiac programs either have a pediatric electrophysiologist as part of their program or an affiliation with an electrophysiologist and his her CMS approved cardiac (and EP) program. The current Florida CMS PEDIATRIC EP STANDARDS state the following: If an institution elects _r30_t 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 CMS approved EP facility as de?ned below. Such protocol must include a formal document signed by the of both involved institutions and approved by the CMS Deputy Secretary for CMS or designee. Comprehensive Cardiology for the Children of Florida 601 5th Street South 711, St. Petersburg, FL, 33701 Tel: 727-322-4830 Fax: 727?821-2461 3003 W. Dr. M.L. King Jr. Blvd., 3rd Floor Tampa FL, 33607 Tel: 813-554-8701 Fax: 813~870-0100 Additional Of?ces in Brandon, Ctearwater, Ft. Mylaramonlta Springs, N. Tampa, Sarasota, St. Petersburg, and Tampa Visit us at Most, but not all CMS approved pediatric cardiac programs have at least one full time electrophysiologist on site. The recently approved Florida Pediatric EP Standards mandate that, at the very least, a well defined relationship with an electrophysiologist and the institution where he/she performs invasive studies is imperative. In addition, I would also strongly recommend developing a well thought out transfer mechanism and at a minimum, periodic visits to the institution by the electrophysiologist. Implementing a system like this is necessary to improve quality of care and patient safety. A pediatric cardiologist should never be in the position of trying to figure out where or to whom transfer a patient in a moment of crisis. Consistency in this process is imperative to ensure quality care by both the referring and the receiving institutions. As a point of reference, in other CMS approved pediatric cardiology cardiac surgical programs across the state, the ratio of cardiologists to electrophysiologists ranges from 1/10 to 1/15, depending on the population in the market and properties of the program. Given the catchment area the hospital serves, and the large number of Pediatric ER visits they receive, the institution should consider hiring a pediatric electrophysiologist who can, at the very least, render part time services and remote consultations until a more permanent arrangement is possible. In that context, the possibility of performing EP studies with ablations in the institution should be strongly considered. PACEMAKERS The device insertions have been performed by Dr. Black or by surgeons at other programs. The larger and older pediatric cardiology practice in the hoSpital manages about 40 pacemaker patients. As a point of reference, The Florida EP Standards suggest that a minimum of 30 pacemaker patients are followed by the pediatric electrophysiologist in a CMS approved pediatric EP program. Currently, pacemaker patients are evaluated by the pacemaker representative of the appropriate brand and the data is shared with the cardiologist, who, in turn, may share and discuss with a pediatric electrophysiologist who may co~manage the patient?s device. The verbal report I received suggests that the larger cardiology group in the program does indeed follow their Comprehensive Cardiology {or the Children of Florida 601 5th Street South at 711, St. Patersburg, FL, 33701 Tel: 727-322-4830 Fax: 727-821-2461 3003 w. Dr. ALL. King Jr. Blvd, 3rd Ftoor Tampa FL. 33607 Tel: 813-554-8701 Fax: 813-870-0100 Additional Offices in Braden, Clearwatar, Ft. MyerslBonlta Springs, N. Tampa, Sarasota, St. Petersburg, and Tampa Visit us at pacemaker outpatients in accordance with the standards delineated by: 2012 Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association-Task Force on Practice Guidelines M. Tracy, MD et al. Am Coll Cardiol. COMMENTS The pediatric cardiology component of the program at St Mary?s has historically served the area very well for many years, collaborating primarily with the three existing pediatric cardiac surgical programs in the southeast Florida region. The cardiac surgical program at St Mary?s is in its early stages of development. The surgical component of the program at St. Mary's Hospital began with the recruitment of Dr. Michael Black, who seems to have put a great deal of effort in developing infrastructure in the operating room. In the early phases, the program lacked an invasive pediatric cardiology component, which raised significant concerns. The program has gradually added expertise in the area of pediatric cardiac anesthesia and has contracted with Dr. Jaychandar for cardiac catheterization support. Nevertheless, the number of catheterization procedures performed seems to be too low for the institution and its staff to acquire and maintain proficiency in these types of challenging procedures. Similarly, the institution does not currently have pediatric electrophysiology expertise nor a pediatric electrophysiology laboratory. Consequently, difficult postoperative or other that may present to the institution's nursery or emergency room, can not be evaluated invasively at St Mary's and are therefore referred to a different program. To my knowledge, there is not an agreement for a pediatric electrophysiologist to provide consultative services. If the number of EP procedures and consults grows sufficiently, the hospital may consider recruiting a pediatric electrophysiologist to develop a pediatric EP program in house. Until then, I would advise them to formalize a relationship with an electrophysiologist and his her institution so that they can consistently, reliably and seamlessly provide support to the program when needed. Comprehensive Cardiology for the Children of Florida 601 5th Street Scum a! 711. St. Petersburg, FL, 33701 Tel: 727-322-4830 Fax: 727-321-2451 3003 W. Dr. Mi. King Jr. Blvd.. 3rd Floor Tampa FL, 33607 Tel: 813-554-8701 Fax: 313-570-0100 Additional Of?ces In Brandon, Clearwater, Ft. Myersmonita Springs, N. Tampa, Sarasota, St. Patersburg, and Tampa Visit us at In closing, a new program.should always consider having all the necessary elements of a complete pediatric cardiology cardiac surgical program in place before performing cardiac procedures so that risks and complications, both foreseen and unforeseen, can be adequately managed internally. This type of comprehensive pre?planning is fundamentally important to achieve the best and safest patient care. We encourage the institution to continue to take the appropriate steps in order to achieve these goals. In doing so, they may wish to refer to the existing CMS Standards for cardiac facilities as a reference to help develop and implement strategies. We remain available to assist and advise in any way we can. Sincerely, a, rge McCormack, MD, MBA, FACC Pediatric Cardiology and ElectrOphysiology Conprehmsive Cardiology for the Children of Florida 601 5th5treet South 5 711, St. Petershurg, FL, 33701 Tel: 127-322-4830 Fax: 727?821-2461 3003 W. Dr. M.L. King Jr. Blvd., 3rd Floor Tampa FL, 33607 Tel: 813-554-8701 Fax: 313-870-0100 Additional Offices in Brandon. Clea-water, Ft. Myers/Bonita Springs, N. Tampa, Sarasota, St. Petersburg, and Tampa Visit us at Johns Hopkins All Children?s Heart Institute Cardiovascular and Thoracic Surgery All Children?s Hospital Outpatient Care Center 601 Fifth Street South Suite 607 St. Petersburg, FL 33701 Phone (727) 767-6666 Fax (727) 767-8606 Jeffrey P. Jacobs, MD Professor of Cardiac Surgery (PAR) Johns Hopkins University Director, AndreWSIDaicoff Cardiovascular Program a Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs Johns Hopkins All Children?s Heart Institute Tampa Address 3003 West Dr. MLK Medical Arts Building, 2"d Floor Tampa, FL 3360? Phone (727) 7674510 Fax (727) 767-2638 a JOHNS HOPKINS MEDICINE Wednesday, April 9, 2014 Re: CMS Site Review Facility Name: St. Mary?s Medical Center and Palm Beach Children's Hospital Date of Review: Tuesday, April 8, 2014 Reviewer: Jeffrey P. Jacobs, MD, FACS, FACC, FCCP This letter constitutes my report of the Child ren's Medical Services (CMS) site visit for St. Mary?s Medical Center and Palm Beach Children's Hospital on Tuesday, April 8, 2014. The Program Evaluation and Development Peer Review of the Pediatric Cardiovascular Center Program at St. Mary's Medical Center Palm Beach Children?s Hospital was completed on April 8, 2014. The review team of the CMS Cardiac Technical Advisory Panel (CTAP) team consisted of: \Mlliam Blanchard, MD (administrative review) Jeffrey P. Jacobs, MD (cardiac surgery) Ira H. Gessner, MD (cardiology) J. Curt Fudge, MD (interventional cardiology) Jorge McCormack, MD (electrophysiology) Kelli Stannard, RN, BSN (CMS of?ce) Chrishonda Jenkins, RN, BSN (CMS of?ce). The main spokespersons for St. Mary?s Medical Center and Palm Beach Children?s Hospital were: 1. Davide M. Carbone, CEO, St. Mary?s Medical Center 2. Michael Black, MD, Director, Pediatric Cardiothoracic Surgery, Palm Beach Children?s Hospital. In addition, we met with numerous members of the Hospital Administration including the chief of medical staff. The pediatric cardiology portion of this visit is reported in separate documents prepared by: 1. Ira H. Gessner, MD (cardiology) 2. J. Curt Fudge, MD (interventional cardiology) 3. Jorge McCormack, MD (electrophysiology). Page 2 April 9, 2015 The CMS visit began at approximately 10:00 am with introductions, followed by a presentation by William Blanchard, MD about the history and overview of Children?s Medical Services Cardiovascular Program and the role of this site review. Then a presentation about the Pediatric Cardiac Program at St. Mary?s Medical Center and Palm Beach Children?s Hospital was made by Davide M. Carbone, CEO, St. Mary?s Medical Center and Michael Black, Director of Pediatric'Cardiothoracic Surgery at Palm Beach Children?s Hospital. These presentations were well attended by multiple members of the Medical, Surgical, and Administrative teams of St. Mary?s Medical Center and Palm Beach Children?s Hospital. - After the PowerPoint Presentations, Dr. Black and I discussed the surgical volume, case mix, and outcome data of Pediatric Cardiac Program at St. Mary?s Medical Center and Palm Beach Children?s Hospital. Multiple chart reviews were then performed. I reviewed 10 consecutive Operative Reports and Discharge Summaries which documented excellent patient care and outcomes. - Ten recent consecutive surgical charts were provided for review. The records were complete and catheten'zation or echocardiography reports as well as operative reports and discharge summaries could be located easily. The ten chart reviews demonstrated excellent quality medicine and surgery. All of the chart reviews demonstrated high quality pediatric cardiac surgery as well as charting and documentation consistent with CMS standards. After the Chart Review, we had lunch. After lunch, the review team toured the intensive Care Unit, Operating Theater, and Catherization Laboratory. It is notable that although the facilities are quite state of the art, zero pediatric cardiac patients were in the hospital. This tour completed our site visit. The overall assessment of the Pediatric Cardiac Program at St. Mary's Medical Center and Palm Beach Children?s Hospital with regard to published CMS guidelines are as follows: 1. Certi?cation of Providers: Michael Black is a fully trained pediatric heart surgeons with excellent credentials. He currently does not have any back-up when he is out of town. 2. Minimum Number of Surgeries: (150 total index cardiac Operations performed per year). The Pediatric Cardiac Program at St. Mary's Medical Center and Palm Beach Children?s Hospital does not currently meet this minimal requirement. In fact, in 2013, the Pediatric Cardiac Program at St. Mary's Medical Center and Palm Beach Children?s Hospital performed only 23 Index Cardiac Operations. 3. Services Provided by the Facility: a. Pediatric cardiac catheterization services are offered at St. Mary?s Medical Center and Palm Beach Children?s Hbspital. St. Mary's Medical Center and Palm Beach Children?s Hospital does has an experienced interventional cardiologist on staff, but he lives quite far from the hospital Page 3 April 9, 2015 and does not have any back-up when he travels. b. St. Mary?s Medical Center and Palm Beach Children's Hospital does not have a pediatric cardiac electrophysiologist on staff. 4. Consolidation of catheterization and surgical services: ("If multiple programs, in different facilities, exist in the same geographic area, every effort shall be made by the State and the facilities to promote consolidation into a single program"). When the Certi?cate of Need (CON) was granted to perform pediatric cardiac surgery at St. Mary?s Medical-Center and Palm Beach Children?s Hospital, one of the stipulations was that the program at St. Mary?s Medical Center and Palm Beach Children?s Hospital would form a formalized collaborative program with another pediatric cardiac center in South Florida. This collaborative relationship never developed. 5. Postogrative Care: Postoperative care is done by a multidisciplinary team involving pediatric cardiac surgery, pediatric cardiology, and pediatric critical care. The postoperative care is consistent with CMS guidelines. The geographical remoteness of the one interventional cardiologist and the lack of electrophysiology is concerning. 6. Surgical Environment: Compatible with CMS guidelines. 7. Eguigment: Compatible with CMS guidelines. lm rovementl Utilization Review: Increased participation in multi-institutional databases is needed, as described below. Page 4 g, 5 SUMMARY: In early December 2013, was asked by St. Mary's Medical Center and Palm Beach Children's Hospital to provide External Peer Review of their Pediatric Cardiac Surgery Program. This letter will not use any infonnation obtained from that con?dential ger review and will only use information known to me outside of the scog of my con?dential @er review. It is common knowledge that multiple pediatric cardiac surgeons (at CMS providing institutions across the state of Florida) have expressed serious concern about babies having complex pediatric cardiac surgery at by St. Mary's Medical Center and Palm Beach Children?s Hospital and subsequently being transferred to other facilities in Florida for the management of major complications. Several of these children have died at the receiving hospital after having undergone complex pediatric cardiac surgery at St. Mary's Medical Center and Palm Beach Children?s Hospital. In response to these complications and deaths from 2011 and 2012, the Pediatric Cardiac Surgery at by St. Mary's Medical Center and Palm Beach Children?s Hospital has made efforts to limit the complexity of the cases that they perform. I commend the team at St. Mary's Medical Center and Palm Beach Children?s Hospital for making this important decision. Concem exists across the State of Florida about the above described mortality and morbidity and also about the extremely low volume of pediatric cardiac surgery being performed at St. Mary's Medical Center and Palm Beach Children?s Hospital. in 2013, St. Mary's Medical Center and Palm Beach Children?s Hospital performed only 23 index cardiac Operation in the entire year. This review is my ?fth CMS site review performed as a reviewer. have never before gone on a CMS site review where the hospital under review had ZERO pediatric cardiac patients in the ICU and ZERO pediatric cardiac patients in the hospital. On our review of April 8, 2014 at St. Mary's Medical Center and Palm Beach Children?s Hospital, ZERO pediatric cardiac patients were in the ICU and ZERO pediatric cardiac patients were in the hospital. This low programmatic volume combined with the transfer out of several children who subsequently died after pediatric cardiac surgery at St. Mary?s Medical Center and Palm Beach Children?s Hospital is not the failure of any one individual; it is the failure of the entire team and system. It is unlikely that any program will be capable of obtaining and sustaining high quality when performing. less than two Index Cardiac Operations per month. The number of cardiac surgical procedures performed seems to be too low for the institution and its staff to acquire and maintain pro?ciency in these types of challenging procedures Furthermore, it is dif?cult for a pediatric cardiac surgeon to perform in isolation from other pediatric cardiac surgeons. When the Certi?cate of Need (CON) was granted to perform pediatric cardiac surgery at St. Mary's Medical Center and Palm Beach Children?s Hospital, one of the stipulations was that the program at St. Mary?s Medical Center and Palm Beach Children?s Hospital would form a Page 5 April 9, 2015 formalized collaborative program with another pediatric cardiac center in South Florida. This collaborative relationship never developed. The pediatric cardiac surgery at St. Mary's Medical Center and Palm Beach Children?s Hospital has been one of the very few programs in the United States of America that does not participate in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. Although St. Mary?s Medical Center and Palm Beach Children?s Hospital have recently started to participate in the STS Database, they have yet to receive a Feedback Report from STS. As of January 2014, 93.6% of hospitals in USA (117/125) participate in the STS Congenital Heart Surgery Database, and the STS Congenital Heart Surgery Database now captures data on greater than 95% of the pediatric cardiac operations in USA. Participation in the STS Congenital Heart Surgery Database will allow the pediatric cardiac program at St. Man/s Medical Center and Palm Beach . Children's Hospital to benchmark itself against national aggregate data about outcomes afterpediatn'c cardiac surgery. Finally, South Florida already has three pediatric cardiac programs, one of' which is also struggling to perform enough cases to meet the minimal volume standards of Florida Children?s Medical Services. This fact, coupled with the very low volumes (and suboptimal outcomes) of pediatric cardiac surgery performed at St. Mary?s Medical Center and Palm Beach Children?s Hospital, makes this reviewer challenge the need for the Pediatric Cardiac Surgical Program at St. Mary?s Medical Center and Palm Beach Children's Hospital to exist. Pediatric cardiac surgery is a highly technical skill that requires awesomeness in multiple domains: - tremendous institutional infrastructure - frequent repetition of multiple volume related skills to achieve success the creation and maintenance of a collaborative and dedicated multidisciplinary team dedicated to achieving excellence and improving quality If this Pediatric Cardiac Surgical Program at St. Mary's Medical Center and Palm Beach Children's Hospital does continue to exist, I have several recommendations: 1. Given the low clinical volumes, the program must not continue to operate in isolation. As was required by the original Certi?cate of Need (CON) that was granted for pediatric cardiac surgery at St. Mary?s Medical Center and Palm Beach Children?s Hospital, the pediatric cardiac surgery at St.? Mary?s Medical Center and Palm Beach Children?s Hospital must form a formalized collaborative program with another successful pediatric cardiac center in South Florida. Isolation of-the pediatric cardiac surgical program and the pediatric cardiac surgeon simply cannot be allowed to continue. 2. The Pediatric Cardiac Surgery Program at St. Mary?s Medical Center and Palm Beach Children?s Hospital must begin to participate in the STS Congenital Heart Surgery Database. Without participation in the STS Page 6 April 9, 2015 Congenital Heart Surgery Database, the pediatric cardiac program at St. Mary's Medical Center and Palm Beach Children?s Hospital cannot properly benchmark itself against national aggregate data about outcomes after pediatric cardiac surgery. 3. The Pediatric Cardiac Surgery Program at St. Mary's Medical Center and Palm Beach Children's Hospital must begin to participate in the Anesthesia Module of the STS Congenital Heart Surgery Database. 4. The Pediatric Cardiology Program at St. Mary?s Medical Center and Palm Beach Children?s Hospital must begin toparticipate in The American College of Cardiology Interventional Cardiology IMPACT Registry. 5. If the pediatric cardiac surgery at St. Mary?s Medical Center and Palm Beach Children?s Hospital does continue to exist, it should only perform pediatric cardiac surgery on patients who meet ALL of the following criteria: - STAT Category 2, or 3 Operations - Patientsolder than 6 months on admission to the hospital - Patients weighing more the 5 kilograms on admission to the hospital. If increased pediatric cardiac surgical volume and improved pediatric cardiac surgical outcomes are achieved at St. Mary?s Medical Center and Palm Beach Children?s Hospital, then these requirements could be gradually modi?ed in a planned and stepwise fashion. 6. If the pediatric cardiac surgery at St. Mary's Medical Center and Palm Beach Children?s Hospital does continue to exist, it should NOT perform pediatric cardiac surgery on patients who meet ANY of the following criteria: - STAT Category 4 or 5 Operations - Patients 6 months or younger in age on admission to the hospital - Patients weighing 5 kilograms or less on admission to the hospital. If increased pediatric cardiac surgical volume and improved pediatric cardiac surgical outcomes are achieved at St. Mary?s Medical Center and Palm Beach Children?s Hospital, then these requirements could be gradually modi?ed in a planned and stepwise fashion. Other new pediatric cardiac programs in Florida have used the strategy described above with excellent clinical outcomes. Peer reviewed literature documents that outcomes after cardiac surgery correlate with the experience of the program and the annual surgical volume of the program. The following reference is one of many that support the relationship between programmatic volume and outcome: Welke KF, O?Brien SM,,Peterson ED, Ungerleider RM, Jacobs ML, Jacobs JP. The Complex Relationship between Pediatric Cardiac Surgical Case Volumes and Mortality Rates in a National Clinical Database. Thorac Cardiovasc Surg. 2009 May; Epub 2009 Mar 17, PMID: 19379979. Page 7 April 9, 2015 The above analysis of the Congenital Heart Surgery Database concludes that ?There was an inverse association between pediatric cardiac surgical volume and mortality that became increasingly important as case complexity increased. Although volume was not associated with mortality for low-complexity cases, lower-volume programs underperforrned larger programs as case complexity increased.? The above recommendations are based on my education, training, and experience, and are supported by the peer reviewed literature. I hope that these recommendations are helpful. It was a pleasure to have the opportunity to visit St. Mary?s Medical Center and Palm Beach Children?s Hospital. I truly hope that my suggestions are helpful. If I can further clarify any aspects of this review, please do not hesitate to contact me. Respectfully submitted, Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP Professor of Cardiac Surgery (PAR), Johns Hopkins University Director, Andrews/Daicoff Cardiovascular Program Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs, - Johns Hopkins All Children's Heart Institute Cardiovascular and Thoracic Surgeon, Johns Hopkins Children's Heart Surgery, All Children's Hospital and Florida Hospital for Children 601 Fifth Street South, Suite 607 Saint Petersburg, Florida 33701, United States of America Office Phone: (727) 767 6666 Office Fax: (727) 767 8606 Cell Phone: (727) 235 3100 Email: