Agency for Health Care Administration Pediatric and Congenital Cardiovascular Center ... · 2018-12-11 · Pediatric and Congenital Cardiovascular Center Standards September 2018

Pediatric and Congenital Cardiovascular Center Standards September 2018

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(Note: Still awaiting guidance for adding or removing this language.) 2

Add Language: This Committee shall be consulted for Certificate of Need applications 3

for new programs under the advisement of the Secretary of AHCA. The appointment of 4

the Panel’s Chair and Vice Chair shall be 2 year terms with a maximum of 4 years. The 5

membership will be determined by local hospital CEOs, with the approval of the 6

Secretary having designation of formal alternatives for voting members. The process of 7

site review and issue of sovereign immunity will be addressed. 8

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(Note: This language was discussed at the 11/29/18 meeting as a potential edit for this 10

document. Members will continue to discuss at the 12/13/18 meeting.) 11

This Committee recommends for volume that the Pediatric Cardiology and Congenital 12

Programs shall maintain a two star rating as determined by the STS. If the program drops 13

below a two star rating, they are subject to a corrective action plan as determined by the 14

PCTAP. 15

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Agency for Health Care Administration 19

Pediatric and Congenital Cardiovascular Center Standards 20

September 2018 21

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Agency for Health Care Administration (AHCA) Pediatric and Congenital 24

Cardiovascular Centers undergo a quality assurance process that ensures such Pediatric 25

and Congenital Cardiovascular Centers (PCCC) meet established minimum standards 26

deemed necessary for the provision of quality cardiac services to children with special 27

health care needs. AHCA supports the creation of policies to foster growth of Centers of 28

Excellence. 29


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The following standards are required for entering into, and continuing in, an agreement 31

with AHCA as a PCCC. An AHCA Pediatric and Congenital Cardiovascular Center will 32

consist of the following co-located components: 33

I. Pediatric and Congenital Cardiology Clinic 34

II. Pediatric and Congenital Echocardiography Laboratory 35

III. Pediatric and Congenital Cardiac Catheterization Laboratory 36

IV. Pediatric and Congenital Cardiac Electrophysiology (EP) Program 37

V. Pediatric and Congenital Cardiovascular Surgery Program 38

VI. Advanced Congenital Cardiac Imaging 39

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An AHCA Pediatric and Congenital Cardiovascular Center must provide care for all 41

PCCC enrolled individuals with congenital and acquired heart disease who require such 42

expertise. For volume standard purposes, “pediatric cardiac” cases include children with 43

congenital and acquired heart disease under age 21 years and adults 21 years or older 44

with congenital heart disease. 45

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For the purposes of AHCA Pediatric and Congenital Cardiovascular Center program 47

evaluation, development and review, each distinct facility component will be surveyed 48


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individually within a multi-site Pediatric and Congenital Cardiovascular Center. Each of 49

its individual components must meet or exceed standards; that is, each hospital-based 50

team must perform the minimum number of echocardiograms, catheterizations, 51

electrophysiologic studies and surgeries specified herein. Each component in the AHCA 52

Pediatric and Congenital Cardiovascular Center shall be evaluated based on its own 53

merits. 54

All AHCA Pediatric and Congenital Cardiovascular Centers must: 55

1. Be located within a healthcare facility that maintains accreditation by the Joint 56

Commission on Accreditation of Healthcare Organizations (JCAHO) and/or the 57

National Committee for Quality Assurance (NCQA). 58

2. Be HIPAA (Health Insurance Portability and Accountability Act) compliant. 59

3. Provide limited English proficiency services, in accordance with Federal 60

guidelines. 61

4. Have quality assurance and quality improvement processes in place that 62

continuously enhance the clinical operation and patient satisfaction with services. 63

5. Actively participate in the Society of Thoracic Surgeons (STS) Congenital Heart 64

Surgery Database. 65

6. Participate in the STS Congenital Heart Surgery Database Anesthesia Module. 66


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7. Participate when fully developed in the Improving Pediatric and Adult Congenital 67

Treatments (IMPACT) databases. 68

9. Collect and submit the following quality assurance data annually, from their 69

annual STS Congenital Heart Surgery Database Report: 70

Number of patients/operations submitted and an analysis of operative 71

mortality, and complexity information, by year 72

Number of patient/operations in analysis, operative mortality, and complexity 73

information, by age group 74

Primary Procedure Operative Mortality 75

STS-EACTS (STAT) (European Association of Cardio-Thoracic Surgery) 76

Mortality Category Operative Mortality, by year 77

STS-EACTS (STAT) Mortality Category Operative Mortality, by age group 78

All AHCA Pediatric and Congenital Cardiovascular Centers must implement electronic 79

medical record technology. 80

All AHCA Pediatric and Congenital Cardiovascular Centers with birthing centers must 81

have a neonatal screening program using pulse oximetry to detect critical congenital heart 82

disease. Data from such a screening program will be transmitted annually, by the 83

involved institutions, to the AHCA. The Secretary of the AHCA shall request the 84


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Surgeon General/Secretary of the Department of Health to forward to the Agency, the 85

annual finding of this screening program. 86

A multidisciplinary cardiac team must include pediatric cardiology, cardiovascular 87

surgery, cardiovascular anesthesia, nursing, ancillary and support staff associated with 88

pre-operative patient selection and preparation, the surgical or catheterization procedure, 89

and post-operative care and follow-up. 90

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All physicians and other licensed healthcare professionals that require credentialing 92

through the Department of Health (DOH) or the Department of Business and Professional 93

Regulation (DBPR) credentialing process and are providing care at an AHCA Pediatric 94

and Congenital Cardiovascular Center must be credentialed providers, as specified in rule 95

64C-4.001 Florida Administrative Code (F.A.C.). 96

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Facilities requesting to be involved as a AHCA Pediatric and Congenital Cardiovascular 98

Center must submit a formal request to the Secretary of AHCA or designee, following 99

the established Certificate of Need (CON) process. 100

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A. Each center shall submit at least two metrics to the American College of 102

Cardiology ACPC Quality Network on a quarterly basis, or a frequency as 103

designated by Qnet. Cardiac centers shall designate appropriate personnel for 104

data collection and submission. 105

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C. A pediatric cardiology clinic must be able to perform diagnostic evaluations 107

including, but not limited to, echocardiographic recording, Holter monitoring, 108

exercise testing, and serial pacemaker monitoring. They must either be able to 109

perform fetal echocardiograms or have access to a fetal echocardiography 110

facility. Each center must annually perform at least 50 procedures each for 111

Holter monitor recordings and serial pacemaker monitoring procedures. Each 112

center must annually perform at least 50 exercise testing studies. 113

D. Fetal echocardiograms performed by a physician outside the physical 114

boundaries of an IAC approved facility may be counted toward the required 115

Facility Volume Standards so long as all of the following criteria are met: 116

1. The physician performing the fetal echocardiogram is on the medical staff of 117

the hospital facility and affiliated with the hospital’s pediatric cardiology 118

program; 119

2. The physician performing the fetal echocardiogram is a credentialed 120

pediatric cardiologist with training in or documented experience in fetal 121


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echocardiography; Maternal-fetal medicine physicians in a PCTV shall 122

involve the pediatric cardiology team prenatally in order to establish the 123

continuum of care for the infant postnatally and to enable a relationship with 124

the parents. 125

3. The program provides evidence that the physician maintains appropriate 126

times of operation and protocols, including proper affiliation agreements to 127

ensure availability and appropriate referrals in the event of emergencies; and 128

4. The fetal echocardiographic laboratory is accredited by IAC. 129

I. Pediatric and Congenital Cardiology Clinic 130

1. Pediatric and Congenital Cardiology Clinic: 131

i) Physicians – The physician in charge of a Pediatric Cardiology Clinic 132

must be board-certified by the Sub-board of Pediatric Cardiology of 133

the American Board of Pediatrics. Recertification or maintenance of 134

competency (MOC) certificates of such a physician will be an integral 135

component of all future program evaluations and development 136

reviews. Board eligibility as an equivalent for board certification will 137

not be considered as a criterion for credentialing beyond 5 years of 138

eligibility unless a specific exception is made by the Secretary of 139

AHCA or designee, upon the recommendation of the PCTAP. 140


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2. Holter Monitoring Laboratory: 141

A physician who is board certified in pediatric cardiology. 142

1. Personnel must have medical record access to previous 143

Holter monitor studies and full print out of arrhythmias for 144

comparison. 145

3. Exercise Treadmill Laboratory: 146

a) A physician who is board certified in pediatric cardiology. 147

b) A Basic Life Support (BLS) certified cardiology technologist or 148

respiratory care practitioner immediately available. 149

c) Pediatric Advanced Life Support (PALS) or ACLS trained personnel 150

in close proximity when a pediatric study <15 years of age is being 151

performed. 152

d) The exercise treadmill lab must include a remote “code” button and 153

telephone. 154

e) Each center should have access to a metabolic exercise laboratory, in 155

which oxygen utilization and the anaerobic threshold can be 156

determined, as an adjunct to detecting early failing cardiopulmonary 157

function. 158


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f) All licensed PCCC institutions should follow the guidelines set forth in 159

the American Heart Association Scientific Statement on "Clinical 160

Stress Testing in the Pediatric Age Group" (Circulation. 2006; 161

113:1905-1920). 162

g) Specifically, licensure as a PCCC requires that involved institutions: 163

a) Maintain an appropriate pediatric exercise physiology 164

laboratory, including 165

1) Age- and size-appropriate treadmill and/or cycle ergometer 166

2) Age- and size-appropriate blood pressure cuffs 167

3) Age- and size-appropriate oxygen saturation monitor 168

4) EKG recording equipment 169

5) An emergency resuscitation cart that includes emergency 170

drugs, a defibrillator, supplemental oxygen, and a portable 171

suction unit 172

6) A log demonstrating periodic testing of the defibrillator and 173

oxygen supply, and periodic inspection of emergency drug 174

expiration dates 175


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b) Conduct all stress tests with at least one person trained in 176

pediatric advanced life support (PALS) in the room at all times 177

with the patient during the test 178

c) Conduct all stress tests with a pediatric cardiologist 179

immediately available (i.e. in the building) 180

d) Perform a minimum of 50 pediatric exercise stress tests per 181

year 182

e) Obtain meaningful written consent for the stress test (which 183

may be a hospital-wide standard consent form filled out 184

specifically for stress testing) 185

h) Licensed PCCC institutions are recommended to: 186

a) Have oversight of the laboratory and testing procedures 187

provided by a physician trained in exercise testing and exercise 188

physiology 189

b) Be able to perform spirometry/pulmonary function testing 190

c) Be able to perform metabolic stress tests 191

d) Be able to perform or refer patients for stress echocardiography 192

e) Be able to perform or refer patients for pharmacologic stress 193

testing 194


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f) Be able to perform or refer patients for nuclear myocardial 195

blood flow imaging 196

4. Serial monitoring and management of implanted electronic devices, such 197

as pacemakers and defibrillators should be an integral component of any 198

center. 199

5. Adult Congenital Heart Clinic- Each licensed PCCC must have a specific 200

adult congenital heart clinic, listed by the Adult Congenital Heart 201

Association (ACHA). Such a clinic should have a physician clinic 202

director with special skills and expertise in dealing with adults with 203

congenital heart disease. 204

6. Adult Congenital Heart Programs: 205

i) All adults with congenital heart disease deserve access to 206

appropriate care. 207

ii) Each Pediatric and Congenital Cardiovascular Center must have as 208

a goal to provide care in alignment with national standards, 209

utilizing as guidelines those of the Adult Congenital Heart 210

Association (ACHA). Each program, within 3 years, shall request a 211

formal site visit by the staff of the AHCA. 212


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iii) AHCA accredited Comprehensive Adult Congenital Heart 213

Programs and regionalization of expertise are encouraged. 214

iv) Existing national and international guidelines, which outline the 215

care provided in adult congenital heart programs, should be 216

utilized. 217

v) All ACHD programs must be registered with the Adult Congenital 218

Heart Association and submit required data at established intervals. 219

vi) Personnel 220

a) The program must be directed by a physician with special skills 221

and training in caring for the adult patient with congenital heart 222

disease. 223

b) ACHD program directors shall be board certified by the ABIM 224

ACHD sub-Board. 225

c) Congenital Heart Surgeon(s) with expertise in the unique 226

surgical aspects and challenges of the adult congenital heart 227

patient. 228

d) Social Worker who is available to the adult patient to provide 229

counseling and support services. 230


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e) A health professional (ARNP or PA) whose role includes 231

coordinating care for ACHD patients. 232

f) Availability of Adult Medicine sub-specialty physicians to 233

provide consultative care. 234

g) All physicians caring for the adult congenital heart disease 235

patient be ACLS certified. 236

h) All staff performing exercise testing on adult congenital heart 237

disease patient be ACLS certified. 238

vii) Clinic Physical Space 239

a) The clinic space used for evaluation of adult patients must be 240

in accordance with their specific needs. 241

b) Facility must be accessible to handicapped Individuals. 242

c) Availability of EKG, X-Rays, MRI studies, Echocardiography, 243

and exercise/metabolic stress testing 244

d) Availability of a conference room for multi-disciplinary 245

meetings. 246

viii) Hospital and Inpatient Facilities 247

a) The admitting facility must have expertise in the care of adults 248

with congenital heart disease. 249


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b) The ACHD Program must have access to a fully equipped 250

cardiac catheterization laboratory with appropriately trained 251

personnel. 252

c) The ACHD Program must meet national standards in all 253

cardiac catheterization interventional and electrophysiology 254

procedures. 255

d) The ACHD Program must offer a comprehensive 256

cardiovascular surgical program, with established commitment 257

from cardiac intensivists, anesthesiologists, and other adult 258

medical and surgical subspecialties. 259

ix) Patient Care Characteristics Specific to an ACHD Program – 260

Recommendations and Specific Requirements: 261

a) Complete transition into the ACHD clinic should be 262

individualized by the treating pediatric cardiologist, taking into 263

account patient age, maturity, special psychosocial needs, and 264

wishes of the parent(s). 265

b) Adult female patients with congenital heart disease must have 266

access to professional staff expert in the management of 267

contraception and pre-pregnancy counseling. In addition, 268


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Genetic Counseling and Fetal Echocardiography studies must 269

be available. 270

c) Pregnant patients with moderate to high complexity congenital 271

heart disease must be evaluated as a High-Risk Pregnancy and 272

referred to Maternal-Fetal Medicine Physicians. 273

d) Health maintenance programs for adolescents and adult 274

patients with CHD should be initiated by providing each 275

patient with information related to, but not limited, to 276

recommendations on endocarditis prophylaxis, anticoagulation 277

therapy, diet, weight control, contraception, pregnancy risk and 278

exercise limitations. 279

e) There must be a major educational component that forms the 280

foundation of the ACHD program that will advance public 281

awareness, educate the medical and health care community and 282

empower those individuals with adult CHD to have 283

opportunities to be successful contributing adults to their 284

respective communities. 285

f) The ACHD program is strongly encouraged to develop 286

partnership with sister institutions to do collaborative research, 287


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cultivate working relationships and form advocacy groups to 288

support their patients with CHD. 289

7. Annual updates on information submitted by each center to the ACHA 290

regarding adult congenital heart disease activities should be forwarded to 291

the AHCA program staff within 30 days of such submission. 292

8. High Risk Obstetrical Cases with Fetal Cardiac Anomalies- Each 293

Pediatric and Congenital Cardiovascular Center must have an established 294

protocol to address the needs of such patients, usually high-risk obstetrical 295

cases having a cardiac fetal anomaly diagnosed by fetal echocardiography 296

and/or ultrasound. 297

F. Physical Facility General requirements for licensed and new PCCC outpatient 298

clinics: 299

1. The area must be suitable for performance of a high quality cardiovascular 300

examination. 301

2. Examination areas must be adequately lighted, have adjustable 302

temperature, and offer privacy to patients. 303

3. A conference room must be available for discussing cases. 304

G. Equipment - All clinic equipment must be monitored and maintained in 305

accordance with manufacturers’ recommendations. 306


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H. Radiological equipment- Access to a Radiological facility at which chest x-307

rays and other indicated radiological studies can be expeditiously performed, 308

including access to Magnetic Resonance Imaging (MRI) studies, particularly 309

to evaluate the large vessels of the chest associated with the heart. 310

I. Records 311

1. Permanent record of real time study must include, at a minimum, video, 312

disk, chart, or digital or electronic medical records. 313

2. Permanent record of real time study of Holter Monitoring studies must 314

include one or more of the following: cassette tape, disk, printed paper, 315

or digital or electronic medical records. 316

3. Permanent record of real time study of exercise treadmill testing must 317

include EKG and blood pressure recordings. 318

4. Permanent record of real time study of serial pacemaker testing must be 319

available. 320

5. Interpretation and final approval of study reports must be performed by a 321

physician who is board certified in pediatric cardiology. 322

6. Medical records must be retained for a period of no less than seven (7) 323

years in a locked area. 324


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J. Initial Evaluation 325

1. Program evaluation and development review: If a request is received for 326

involvement as a PCCC co-located Pediatric Cardiology Clinic, along 327

with attestation of compliance with these standards, a program evaluation 328

and development review may be requested by the Secretary of AHCA and 329

performed by members or designees of the Pediatric Cardiac Technical 330

Advisory Panel (PCTAP). A request for involvement shall not be deemed 331

complete until the Secretary of AHCA or designee receives the 332

recommendation of the PCTAP. 333

2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 334

cases within a specified time period must be available to warrant initial 335

evaluation of any facility. 336

3. Facility and Practitioner Volume Standards: A facility requesting to 337

participate as a licensed Pediatric and Congenital Cardiovascular Center 338

must meet requirements for and have documentation of IAC accreditation. 339

4. Facility Criteria: include all standards in the PCCC co-located Pediatric 340

Cardiology Clinic Component section. 341

5. The Secretary of AHCA or designee shall consider new facilities upon the 342

completion of CON approval and requirements and the advisory 343


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recommendation of the PCTAP and the criteria established above. The 344

Secretary of AHCA or designee shall make the final decision on whether a 345

facility may participate by entering into an agreement with the Agency for 346

Health Care Administration. 347

K. Re-evaluation of licensed Pediatric and Congenital Cardiovascular Centers 348

2. Facility and Practitioner Volume Standards: Meets requirements for IAC 349

accreditation. 350

3. IAC Accreditation: By the initial or subsequent program evaluation and 351

development review, all echocardiography laboratories, Transthoracic 352

Echoes (TTE), Trans Esophageal Echoes (TEE) and Fetal Echoes (FE) 353

must be accredited by the IAC, whether within the center or “off-site”. 354

I. The Secretary of AHCA or designee considers existing facilities for continuing 355

involvement upon the recommendation of the PCTAP and the criteria established 356

above. The Secretary of AHCA or designee shall make the final decision on 357

whether or not a facility may continue such an agreement with the Agency. 358

II. Pediatric and Congenital Echocardiography Laboratory 359

A. Congenital Echocardiographic Imaging Laboratory 360

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Echocardiographic Imaging is a vital tool often relied upon by all of the other 362

components of a Pediatric Cardiovascular Center. A Congenital 363


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Echocardiographic Imaging Laboratory must be accredited (and reaccredited 364

when accreditation expires) for Pediatric Echocardiography by the Intersocietal 365

Accreditation Commission (IAC) in order to perform Transthoracic Echoes 366

(TTE), Trans Esophageal Echoes (TEE) and Fetal Echoes (FE). The IAC 367

accreditation process is a rigorous process that is constantly being improved and 368

revised by national experts in this field. The IAC standards and guidelines spell 369

out responsibilities for Echo Lab Medical Director, Technical Director, Medical 370

Staff, Technical Staff, and for Support services. As well the IAC spells out 371

standards and guidelines for the Echo Lab Facility, Echo examination reports 372

and records, and Echo Lab safety. The IAC also mandates the facility must have 373

a written Quality Improvement (QI) program for all imaging procedures. The 374

IAC makes some accommodations for its standards and guidelines that may be a 375

challenge for smaller Pediatric Cardiovascular Centers. The IAC standards and 376

guidelines will not be separately listed here, details can be found at 377

www.intersocietal.org. 378

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III. Pediatric Cardiac Catheterization Laboratory Component 380

A. The Pediatric Cardiac Catheterization Laboratory must be co-located within 381

a facility completely equipped to accommodate all aspects of the medical 382

and surgical care of the patient. 383

2012 American College of Cardiology Foundation/Society for 384

Cardiovascular Angiography and Interventions Expert Consensus Document 385

https://clicktime.symantec.com/a/1/yYm3B3DpVV2pzSRMHsZvOju4jd8WAvQ0E7SmMF-4LgY=?d=ImrY-admbZNmvFUI6xcYAG0sKVQC4nl1eS0gMPMT6NGyCcv9WQwosAaqnVx_9JuPQrbJhOQJq6xjHZ6mK6prDvfl3YbvVN59FziMhdL7DE2ri0wLepPLcQkuX9ZoQua4erxz2Kxupxk-urJTnqo0jq4nKJGQcPbjMlRUNxWgmQNoUnHVoTiVMdH3P_qOVWOvu8eFZk_9L9TZEghd0rj1PoFDhHAArwugUXcFymqpoI3fa3t5MGGWxN6ScQYLw6JqGJN94k_ug2sUANbWuxnie29XrOuSoq6PCQiINcJ7eg7TkJH5VsgRCdM2mu2RvvDrU0GHIpXyUURLNC8VsXVg9nn-jsi3FSZzC65bdEHaQ7kDItzmLFRSkeEsdirRPuTJ3jF-85iYHoGoqHw%3D&u=https%3A%2F%2Furldefense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__clicktime.symantec.com_a_1_HG0eZXMVYzQodt8Ao66Gvlb3US4ubM73b9iADI-5FAjgc-3D-3Fd-3D6Ps8IHziwTr1RCXpWwLjjDTmtUMVyBZaD-2DfTF1LT6mBdlFSMpSQ-2DJIxXyJbya-5FG9f5g5VHb0jS6zZ568XaWS4L1D8iKRBQYip5GGMp6JxVLhDUf-2DTf-2DW6X2DrBcLcEWWQ1c2Xug3bAJSu-2DS-5F1GnvaGmLlk9Vy403lpO2zfXZh5uT25FjJfmjfcAuPmQGmrc7oehXtbn3DRRBxoVoUexjBCZiY4B1-2DswJnHXb4fqIgxY4pjAyLFA6mjQB9Ze-2DZFzJEE3o6EtgFUKky0i-5FDjGbvRNJrHhGFWArWD-2DRa-2DDHLMCXb7xgtQw5RzFE043RumhYWA0DwKdFBXvEjN8-2DjY7n18oSNxh6jQZcY1FE3IJog0-2DIuTwgcL31eFHRSvxvYHoU89VbLxr5Bbv4BQ-253D-253D-26u-3Dhttp-253A-252F-252Fwww.intersocietal.org%26d%3DDwMFAg%26c%3DpZJPUDQ3SB9JplYbifm4nt2lEVG5pWx2KikqINpWlZM%26r%3DjZaEs16gdeVR6DvurEzVknKmxfhDwk5t66s8p6OvXnk%26m%3DzN53REu8zGRiALWGc6f_2Wtf1JnlWv7GvntXQDw63hI%26s%3DBuvhivsJ4CitSLzNDpGLG2Mj_865X3r_umkAM8z5_Ok%26e%3D


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on Cardiac Catherization Laboratory Standards Update. J Am College 386

Cardiology. 2012; Vol. 59 No. 24 221-2305. 387

B. Cardiac Team 388

1. Physician in Charge 389

The physician in charge of the procedure must be board-certified by the 390

Sub-Board of Pediatric Cardiology of the American Board of Pediatrics. 391

Pediatric cardiologists either trained in other countries or for any reason 392

not eligible for certification by the Sub-Board of Pediatric Cardiology of 393

the American Board of Pediatrics and have completed additional 12 394

months fellowship in interventional pediatric cardiology may be 395

credentialed as a DOH physician by the Secretary of AHCA or designee, 396

as a special situation after a review and in-depth evaluation by the 397

Pediatric Cardiac Technical Advisory Panel, which recommended such 398

approval. 399

2. Consulting Physicians 400

In addition to the physician listed above, in interventional cardiac 401

catheterizations, an anesthesiologist and a thoracic surgeon, each with 402

advanced training in the cardiovascular aspects of their specialty, must be 403

immediately available within the facility or in close proximity for 404


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consultation, assistance, emergency and elective surgical procedures and 405

peri-operative care. 406

3. Nurse 407

Each laboratory must have a registered nurse, with special training in 408

cardiovascular techniques and in the care of children, as a full time 409

member of the team. This nurse must have special skills in pre-410

catheterization evaluation and instruction of the patient and family, care of 411

the patient post-catheterization, and discharge teaching for the patient and 412

family. 413

4. Cardiovascular Technologist 414

Each laboratory must have a cardiovascular technologist with special 415

training in cardiac catheterization laboratory techniques. 416

5. Dedicated Trained Cardiovascular Recorder 417

Each laboratory must have a dedicated trained cardiovascular recorder 418

who has no other responsibilities during procedures. 419

6. Each laboratory must have immediate access to personnel trained in 420

equipment repair and maintenance. 421

7. Although the above required functions are well defined, it is not necessary 422

for one person to fulfill each separate job category. Well defined adequate 423


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cross training for other personnel classifications permits 24-hour coverage 424

of essential team functions. 425

8. All technologists in a cardiovascular laboratory must be certified by the 426

Cardiovascular Credentialing Institute as a Registered Cardiovascular 427

Technologist (RCVT) and licensed by the State of Florida under the 428

Clinical Laboratory law, when applicable. 429

C. Equipment: Radiological, electronic, and computer-based systems are integral 430

components of the equipment in a catheterization laboratory. These systems 431

all require a program of rigorous maintenance and troubleshooting. For 432

pediatric patients, biplane angiography, higher frame rates (30-60 fps), and 433

higher injection rates (up to 40 mL/s) are required to help define abnormal 434

intra-cardiac anatomy. The catheterization laboratory must be able to perform 435

procedures in a patient supported by extracorporeal membrane oxygenation 436

(ECMO). 437

2012 American College of Cardiology Foundation/Society for Cardiovascular 438

Angiography and Interventions Expert Consensus Document on Cardiac 439

Catherization Laboratory Standards Update. J Am College Cardiology. 2012; 440

Vol. 59 No. 24 221-2305. 441

D. Electrical Safety and Radiation Protection 442


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Electrical safety and radiation protection shall be followed in accordance with 443

the manufacturer’s recommendations and applicable State and Federal 444

regulations. 445

E. Records 446

1. Permanent record of real time study must include, at a minimum, video, 447

disk, chart, or digital / electronic recordings. 448

2. Interpretation and final approval of study reports must be performed by a 449

physician who is board certified in pediatric cardiology. 450

3. Medical records must be retained for a period of no less than seven (7) 451

years in a secure locked area. 452

F. Initial Evaluation 453

1. Program Evaluation Review: When a request is received for participation 454

as an AHCA licensed Cardiac Catheterization Laboratory facility, along 455

with attestation of compliance with all these standards, a program 456

evaluation and development review may be requested by the Hospital 457

CEO and the Secretary of AHCA to be performed by members or 458

designees of the PCTAP and scheduled as the final component of the 459

application process. A request for participation shall not be deemed 460


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complete until the Secretary of AHCA or designee receives the 461

recommendation of the PCTAP. 462

2. Facility Volume Standards: The minimum annual number of pediatric 463

cardiac catheterizations in a facility requesting to participate as an AHCA 464

Pediatric and Congenital Cardiovascular Center is 150 per facility (with a 465

minimum of 50 interventional). 466


Cardiovascular Angiography and Interventions Expert Consensus 468

Document on Cardiac Catherization Laboratory Standards Update. J Am 469

College Cardiology. 2012; Vol. 59 No. 24 221-2305. 470

3. Practitioner Volume Standards: The minimum annual number of 471

pediatric cardiac catheterizations performed by each practitioner in a 472

facility requesting to participate as an AHCA licensed Pediatric and 473

Congenital Cardiovascular Center is 50 per year. Practitioners doing 474

interventional procedures must do a minimum of 25 interventional 475

catheterizations per year. 476


Cardiovascular Angiography and Interventions Expert Consensus 478


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Document on Cardiac Catherization Laboratory Standards Update. J Am 479

College Cardiology. 2012; Vol. 59 No. 24 221-2305. 480

5. Facility Criteria: include all standards in the AHCA Pediatric Cardiac 481

Catheterization Laboratory Component section. 482

6. The Secretary of AHCA or designee considers new facilities for 483

involvement upon the recommendation of the Pediatric Technical 484

Advisory Panel (PCTAP) and all the criteria established above for 485

pediatric cardiac catheterizations. The Secretary of AHCA or designee 486

shall make the final decision on whether or not a facility may continue 487

such entering into an agreement with the Agency. 488

IV. Pediatric and Congenital Cardiac Electrophysiology (EP) Program 489

A Pediatric Cardiac Electrophysiology (EP) Program is an integral part of an 490

AHCA Pediatric and Congenital Cardiovascular Center. The EP program has 491

two main components: (1) An Interventional program in a Pediatric Cardiac 492

Electrophysiology Laboratory and (2) A non-invasive inpatient and outpatient 493

arrhythmia evaluation and management service. 494

An institution participating as an AHCA Pediatric and Congenital 495

Cardiovascular Center, may elect not to participate in both components of 496

these EP Standards. 497


27

All AHCA designated centers must participate in the outpatient arrhythmia 498

evaluation, management, and consultation services. 499

If an institution elects not to participate in the EP interventional program in a 500

pediatric cardiology electrophysiology laboratory, it must have a written 501

format establishing an effective triage to another AHCA EP facility as defined 502

below. Such a protocol must include a formal document signed by the CEO’s 503

of both involved institutions and approved by the Secretary of AHCA or 504

designee. 505

506

A. Laboratory Component: The Pediatric Cardiac Electrophysiology Laboratory 507

must be co-located within a facility completely equipped to accommodate all 508

aspects of the medical and surgical care of the pediatric patient. 509

1. Cardiac Team 510

i) Physician in Charge: The physician in charge of the laboratory must be 511

board-certified by the Sub-Board of Pediatric Cardiology of the 512

American Board of Pediatrics and must be a pediatric 513

electrophysiologist as defined below: 514


28

a) Pediatric Electrophysiologist is a Pediatric Cardiology Board 515

Certified physician, whose primary clinical practice is dedicated to 516

pediatric electrophysiology activities. 517

b) In addition, the individual to be credentialed by DOH as a pediatric 518

electrophysiologist must meet the International Board of Heart 519

Rhythm Examiners (IBHRE) board eligibility criteria by meeting 520

or exceeding the requirements outlined by one or both of the tracks 521

outlined below: 522

International Board of Heart Rhythm Examiners. Eligibility 523

Requirements Policy: IBHRE Board Certification Examination in 524

Cardiac Electrophysiology for the Physician 10.29.2010 525

Pediatric Electrophysiologist: Credentials 526

1) Track 1: Training Completed After July 1, 2005 527

(i) Successful completion of a pediatric and congenital 528

cardiovascular medicine fellowship program and board-529

certified in Pediatric Cardiology by the American Board of 530

Pediatrics. 531

(ii) Successful completion of a minimum of 1 additional year 532

of cardiac electrophysiology training in a pediatric 533


29

electrophysiology fellowship program. The training 534

program must meet the minimum criteria set forth by the 535

task force in pediatric cardiology training. ACCF/AHA/AAP 536

Recommendations for Training in Pediatric Cardiology. 537

A Report of the American College of Cardiology 538

Foundation/American Heart Association/American 539

Committee to Develop Training Recommendations for 540

Pediatric Cardiology) College of Physicians Task Force on 541

Clinical Competence Circulation. 2005; 112:2555-2580 542

And 543

Recommendations for Advanced Fellowship Training in 544

Clinical Pediatric and Congenital Electrophysiology 545

Walsh, Edward P. et al. 546

Heart Rhythm, Volume 10, Issue 5, 775 - 781 547

548

(iii)In addition, the electrophysiologist must monitor on a 549

continuing basis at least 30 patients with cardiovascular 550

implanted electronic devices (CIEDs). However, the 551


30

involved pediatric electrophysiologist does not necessarily 552

have to perform all such device implantations 553

2) Track 2: Training Completed Before July 1, 2005 554

(i) Pediatric EP applicants completing training prior to July 1, 555

2005 may qualify either by satisfying Track 1 requirements 556

above, or by demonstrating a minimum level of practice 557

experience consisting of at least 5 years of active pediatric 558

electrophysiology experience, in which the applicant’s 559

primary clinical interest is pediatric electrophysiology. The 560

candidate must be actively involved in the management and 561

care of pediatric arrhythmia patients. 562

(ii) Past Experience: 563

(a) A minimum 5 year history of practicing pediatric 564

electrophysiology as his or her primary clinical interest. 565

(b) In that 5 year span, performance of a minimum of 150 566

EP studies of which at least 90 or 60% of the total must 567

have been catheter ablation procedures. 568

ACCF/AHA/AAP Recommendations for Training in 569

Pediatric Cardiology. A Report of the American College 570


31

of Cardiology Foundation/American Heart 571

Association/American Committee to Develop Training 572

Recommendations for Pediatric Cardiology) College of 573

Physicians Task Force on Clinical Competence 574

Circulation. 2005; 112:2555-2580 575

And 576

Recommendations for Advanced Fellowship Training in 577

Clinical Pediatric and Congenital Electrophysiology 578

Walsh, Edward P. et al. 579

Heart Rhythm, Volume 10, Issue 5, 775 - 781 580

581

(c) In addition, the individual must monitor on a continuing 582

basis at least 30 patients with (CIEDs). However, the 583

involved pediatric electrophysiologist does not 584

necessarily have to perform any or all such (CIED) 585

implantations. 586

(d) All Pediatric Electrophysiologists must be Board 587

Certified by IBHRE. 588


32

3) Foreign Trainees: Pediatric cardiologists either trained in 589

other countries, or for any other reason not eligible for 590

certification by the Sub-Board of Pediatric Cardiology of 591

the American Board of Pediatrics may be credentialed as a 592

DOH physician specializing in electrophysiology by the 593

Surgeon General/Secretary of the Department of Health or 594

designee as a special situation after a review and in-depth 595

evaluation by the Pediatric Cardiac Technical Advisory 596

Panel, which recommended such credentialing. 597

ii) Consulting Physicians: In addition to the physician listed above, 598

during interventional EP cardiac catheterizations, an anesthesiologist 599

and a thoracic surgeon, each with advanced training in the 600

cardiovascular aspects of their specialty, must be immediately 601

available within the facility, or in close proximity, for consultation, 602

assistance, emergency and elective surgical procedures and peri-603

operative care. 604

iii) Nurse: Each laboratory must have a registered nurse, with special 605

training in cardiovascular techniques and in the care of children, as a 606

full time member of the team. This nurse must have special skills in 607


33

pre and post catheterization evaluation, and management. In addition, 608

this individual must be skilled in the coordination of patient and family 609

education and provision of instructions pre and post procedure. 610

iv) Cardiovascular EP Technologist: Each laboratory must have a 611

cardiovascular EP technologist with special training in cardiac EP 612

laboratory techniques. 613

v) Dedicated Trained Cardiovascular EP Recorder: 614

a) Each laboratory must have a dedicated trained cardiovascular EP 615

recorder who has no other responsibilities during such 616

procedures. 617

b) Each laboratory must have immediate access to personnel trained 618

in equipment repair and maintenance. 619

c) Although the above-required functions are well defined, it is not 620

necessary for one person to fulfill each separate job category. 621

Adequate cross training for other personnel classifications 622

permits 24-hour coverage of essential team functions. 623

d) All technologists in a cardiovascular laboratory must be certified 624

by the Cardiovascular Credentialing Institute as a Registered 625


34

Cardiovascular Technologist (RCVT) and licensed by the State 626

of Florida under the Clinical Laboratory law, when applicable. 627

2. Equipment: 628

i) Radiological, electronic, and computer-based systems are integral 629

components of the equipment in a catheterization laboratory. These 630

systems all require a program of rigorous maintenance and 631

troubleshooting. A pediatric electrophysiology laboratory must have: 632

a) Multi Channel EP recording system 633

b) External Defibrillation system 634

c) Cardiopulmonary monitoring system 635

d) Radiofrequency Energy Source 636

e) It is strongly recommended that Pediatric Electrophysiology 637

laboratories also have: 638

1) 3 Dimensional Mapping System 639

2) Cryo ablation System 640

ii) Electrical Safety and Radiation Protection: Electrical safety and radiation 641

protection shall be followed in accordance with the manufacturer’s 642

recommendations and applicable State and Federal regulations. 643

3. Records 644


35

i) Permanent record of real time study must include, at a minimum, video, 645

disk, chart, or digital / electronic recordings. 646

ii) Interpretation and final approval of such EP study reports must be 647

performed by a physician who is board certified in pediatric cardiology 648

and meets the standards to be qualified as a pediatric electrophysiologist, 649

as defined previously. 650

iii) Medical records must be retained for a period of no less than seven (7) 651

years in a secure locked area. 652

4. Initial Evaluation 653

i) Program Evaluation and Development Review: When a request is received 654

for participation as an AHCA Pediatric Cardiac Electrophysiology 655

Laboratory facility, along with attestation of compliance with all these 656

standards, a program evaluation and development review by members or 657

designees of the Pediatric Cardiac Technical Advisory Panel may be 658

scheduled as the final component of the application process at the request 659

of the Hospital CEO and the Secretary of AHCA. An application shall not 660

be deemed complete until the Secretary of AHCA or designee receives the 661

recommendation of the Pediatric Cardiac Technical Advisory Panel. 662

ii) Medical Records Review: 663


36

a) A minimum of 12 consecutive pediatric cardiac catheterization 664

electrophysiologic studies within a year must be available to warrant 665

initial inspection of any facility. 666

b) A minimum of 7 consecutive pediatric implantable device insertions 667

(pacemakers and / or Implantable Cardioverter Defibrillators) studies 668

within a year must be available to warrant initial inspection of any 669

facility. 670

iii) Facility Volume Standards: Facilities shall be evaluated independently for 671

two separate areas of expertise within a pediatric electrophysiology 672

program: EP studies with ablations and device insertions. 673

a) EP studies and ablation: The minimum annual number of pediatric 674

electrophysiologic studies in an applicant facility is recommended to 675

be at least 30 per facility with a minimum of 18 ablations, or 60% of 676

the total number of studies per year. 677

Source: PACES SURVEY, 2012 678

b) CIED implantations: Pacemaker and Implantable - Cardioverter 679

defibrillators (ICD) insertions. The minimum number of combined 680

CIED implantations (pacemakers and ICD’s) in an applicant facility is 681

recommended to be at least 10 per year. For the purpose of facility 682


37

volume standards, CIED insertions may be performed by either a 683

credentialed AHCA pediatric and congenital cardiovascular surgeon 684

and /or a credentialed DOH pediatric electrophysiologist. 685

iv) Practitioner Volume Standards: 686

a) Pediatric electrophysiologists shall be evaluated independently for two 687

separate areas of expertise within a pediatric electrophysiology 688

program: EP studies with ablations and CIED Insertions 689

b) A practitioner may choose to be credentialed to perform EP studies / 690

ablations and CIED insertions, or both. 691

1) The minimum annual number of pediatric cardiac 692

electrophysiologic studies performed by each practitioner in an 693

applicant facility is recommended to be at least 30 per year, of 694

which at least 18, or 60% of the total number of studies per year, 695

are catheter ablation procedures. 696

2) If the Pediatric Electrophysiologist is the physician performing 697

CIED insertions, the minimum annual number of pediatric device 698

implants (pacemaker and/ or ICD) performed by each practitioner 699

in an applicant facility is recommended to be at least 10 per year. 700


38

Electrophysiology Society Clinical Competency Statement: 701

Training pathways for implantation of cardioverter-defibrillators 702

and cardiac resynchronization therapy devices in pediatric and 703

congenital heart patients. Developed in collaboration with the 704

American College of Cardiology and the American Heart 705

Association. J. Philip Saul, MD, FHRS, Victoria L. Vetter, MD, 706

Heart Rhythm, Vol 5, No 6, June 2008 707

(i) Practitioners whose volume falls below 10 per year must then 708

demonstrate that they have an established working relationship 709

with either a credentialed DOH pediatric and congenital 710

cardiovascular surgeon or a credentialed DOH pediatric 711

electrophysiologist performing CIED implants or an adult 712

electrophysiologist trained in CIED implantation, and 713

demonstrate that such physicians are available in case they are 714

needed. 715

v) Outcomes Standards: 716

The members of the AHCA PCTAP Cardiac Technical Advisory Panel’s 717

EP Task Force will develop and recommend that all AHCA Cardiac 718

Centers participate in a database into which the involved EP physicians 719


39

would report the outcomes of their EP Studies and device insertions. Such 720

database recommendations will be submitted to the AHCA PCTAP 721

Cardiac Technical Advisory Panel and implemented if the Panel supports 722

such recommendations. 723

a) Outcomes Reporting Standards 724

(i) All Electrophysiologic studies must be reported to IMPACT –. 725

i. Procedural data must be entered in the report 726

within a week of the procedure. The data 727

shall be submitted to the IMPACT registry at 728

intervals no less frequent than quarterly. 729

ii. Long term success and complication data 730

shall be reported at IMPACT-between 3 731

months and 12 months of the procedure 732

date. 733

(ii) Endocardial Device Insertion Procedures. Acceptable success 734

and complication rates are not yet defined in the pediatric 735

population. However, outcomes will be reported in databases 736

currently under development for outcomes analysis. 737


40

(iii)Epicardial Device Insertion procedures are considered cardiac 738

surgeries and outcomes evaluated in the context of the involved 739

cardiovascular surgical program. 740

b) Outcomes Standards- Second Phase: 741

1) When national outcome standards are defined, they will be 742

submitted to the PCTAP as the new outcome standards for Florida 743

AHCA pediatric electrophysiology centers. 744

2) Once procedural success and complication rates are measured and 745

published, the PCTAP Task force shall recommend that acceptable 746

program and or practitioner volume and outcomes are within two 747

standard deviations from the national mean. 748

vi) Facility Criteria: Includes all standards in the AHCA Pediatric Cardiac 749

Catheterization Laboratory Component section. 750

5. Re-evaluation of AHCA Centers: 751

a) Program Evaluation and Development Review: Each AHCA Pediatric Cardiac 752

Electrophysiology Laboratory Facility may be evaluated on-site by members 753

or designees of the Pediatric Cardiac Technical Advisory Panel at a minimum 754

of once every three (3) years at the request of the hospital CEO and the 755

Secretary of AHCA. The re-evaluation process is not complete until the 756


41

Secretary of AHCA or designee receives the recommendations of the Pediatric 757

Cardiac Technical Advisory Panel. 758

b) Medical Record Review: A minimum of 12 consecutive pediatric cardiac 759

electrophysiologic studies must be available within a specified time period for 760

review at the time of the re-evaluation. Volume Standards are as follows: 761

c) Facility Volume Standards: The minimum annual number of pediatric 762

electrophysiologic studies in an applicant facility is recommended to be at 763

least 30 per facility with a minimum of 18 ablations, or 60% of the total 764

number of studies per year. 765

d) Practitioner Volume Standards: 766

(i) By the first or subsequent three-year review, the minimum annual number 767

of pediatric cardiac electrophysiologic studies performed by each 768

practitioner in an applicant facility is recommended to be at least 30 per 769

year, of which at least 18, or 60% of the total number of studies per year 770

are catheter ablation procedures. 771

(ii) Pediatric electrophysiologists performing CIED implantations are 772

recommended to perform at least 10 CIED implantation procedures per 773

year. 774


42

e) During the initial phase of the development of outcomes standards, defined in 775

Section III.A.4.v) a), EP facilities will be evaluated by examining their 776

completeness of data submission. During this initial phase, the primary 777

evaluative assessment will be procedural outcomes as deemed acceptable 778

based on existing literature. 779

f) The second phase of outcomes evaluation, Section III.A.4.v)b), will be 780

completed once national standards are derived IMPACT- into which all 781

Florida EP programs are expected to submit their data outcomes, then the 782

facility will be reviewed by the Pediatric Cardiac Technical Advisory Panel 783

which may recommend that the facility be placed on probationary status for 784

one year. Probationary status may be extended one (1) additional year if the 785

facility documents a positive trend in meeting the outcomes standard. If the 786

facility has not achieved the acceptable outcomes standard at the end of the 787

second year of probationary status, the facility shall be provided with a notice 788

of intent to end the agreement between the AHCA Pediatric and Congenital 789

Cardiovascular Center and the Agency. After a 90 day transition period, the 790

facility will receive a formal notice to end the agreement between the AHCA 791

Pediatric and Congenital Cardiovascular Center and the Agency. 792

B. Outpatient Clinic Component 793


43

1. Facility Criteria: include all standards, as outlined in the outpatient clinic 794

section. In addition, an outpatient electrophysiology program must have 795

the following components: 796

i) Personnel: 797

a) The physician in charge of this clinic is to be board eligible or 798

board certified by the IBHRE and Basic Life Support and have 799

special expertise in arrhythmias and device management. The 800

physician must be IBHRE certified within 5 years of becoming 801

Board eligible. 802

b) The involved nurse/technician is to have special expertise in CIED 803

management and be certified in both Basic Life Support and 804

Pediatric Advanced Life Support. 805

ii) Device Management: Pacemaker, Implantable Cardioverter 806

Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) 807

device monitoring is performed by combining both in-clinic and 808

remote (home) monitoring. Criteria for intervals for CIED follow-up 809

must recognize that the complexity of the underlying heart disease 810

dictates the intervals for such surveillance. A reasonable guide for in-811

clinic monitoring is as follows: 812


44

a) Antibradycardia devices: At a minimum, the patient will be seen in 813

the clinic one week and then 3 months post implant. Then the 814

patient should be seen no less frequently than annually as long as 815

clinic visits are supplemented by remote monitoring from home no 816

less frequently than every three months, and more frequently as 817

may be clinically indicated. Complexity of the issues managed or 818

CIED related issues may require a more intensive and frequent 819

monitoring schedule. Evaluation of surgical site may be performed 820

by physicians in the patient’s local community when deemed 821

appropriate. 822

b) ICD and CRT devices: At a minimum, the patient will be seen in 823

the clinic within one week and then 3 months post implant. Then 824

the patient should be seen no less frequently than bi-annually as 825

long as clinic visits are supplemented by remote monitoring from 826

home no less frequently than every three months, and more 827

frequently as may be clinically indicated. Complexity of the issues 828

managed; or device related issues, may require a more intensive 829

and frequent monitoring schedule. Evaluation of surgical site may 830


45

be performed by physicians in the patient’s local community when 831

deemed appropriate. 832

2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for 833

Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report 834

of the American College of Cardiology Foundation/American 835

Heart Association Task Force on Practice Guidelines Cynthia M. 836

Tracy, MD et al. J Am Coll Cardiol. 2012;60(14):1297-1313. 837

iii) Equipment 838

a) For in-clinic monitoring – the following items must be available: 839

Electrocardiographic (EKG) recording machine, external 840

defibrillator, and proprietary CIED programmers from every 841

company pertinent to the patients being seen. 842

b) For remote monitoring, some form of surveillance must be 843

available including traditional trans-telephonic monitoring (TTM). 844

iv) Volume: It is recommended that the involved EP physicians should 845

have managed, in their professional career, at least 75 patients with 846

devices and maintained competence by performing 30 assessments 847

annually. 848


46

v) Records: A complete database of patients with devices should be 849

maintained and to include all device models and ID numbers, Lead 850

models and ID numbers. 851

a) Records generated from the pacemaker visits shall be maintained 852

for a minimum of 7 years. 853

vi) Arrhythmia Management 854

a) Pediatric Electrophysiology clinics must be staffed by a pediatric 855

electrophysiologist and at least one skilled nurse. Visit frequency is 856

dictated individually by the severity of the arrhythmia. 857

1) It is recommended that visits include: Visits are recommended 858

to include: 859

(i) Review of symptoms, antiarrhythmic drug (AAD) side 860

effects, AAD doses and dose adjustments, and drug-drug 861

interactions. 862

(ii) Consideration of tests that may be used to determine 863

arrhythmia and CIED status, including 12 lead 864

electrocardiogram, Holter monitor, event or memory 865

looping monitors, exercise testing, and specialized imaging. 866


47

(iii)Cardiac channelopathy patients are monitored as frequently 867

as the specific disease requires. Proper management of 868

these syndromes is recommended to include genetic testing 869

of the proband followed by family specific testing, and 870

genotype specific drug management and counseling. 871

V. Pediatric and Congenital Cardiovascular Surgery Program 872

The Secretary of AHCA or designee considers existing facilities for continuing 873

involvement based upon the recommendation of the Pediatric Cardiac Technical 874

Advisory Panel and all the criteria established above. The Secretary of AHCA or 875

designee shall make the final decision as to whether or not to continue such an agreement 876

with the Agency. 877

A. Diagnosis and treatment are so closely related that an AHCA Pediatric and 878

Congenital Cardiovascular Surgical Program, AHCA Pediatric Cardiac 879

Catheterization Laboratory Component and an AHCA Pediatric Cardiology 880

Clinic Component must be co-located on the same campus. 881

B. General pediatric coverage with sub-specialty capability twenty-four hours a 882

day, seven days a week. 883

C. An effective system (with documentation) of rapid referral and transportation. 884


48

D. Cardiac Team – Pediatric and Congenital Cardiovascular Surgical Program 885

must have accredited pediatric and general surgery training programs with 886

house staff or must have other arrangements to provide 24-hour physician or 887

house staff coverage. 888

1. DOH credentialed thoracic and cardiovascular surgeon with special 889

training, interest and experience with pediatric cardiac patients and 890

certification by the American Board of Thoracic Surgery. All such 891

surgeons will have 5 years to become Board Certified after becoming 892

eligible for such an examination. 893

2. DOH credentialed associate thoracic and cardiovascular surgeon with 894

special training interest and experience with pediatric cardiac patients and 895

certification by the American Board of Thoracic Surgery. Such an 896

associate surgeon should be either “on-site”, available through an 897

established agreement with another AHCA Pediatric and Congenital 898

Cardiovascular Center, or available by an established organizational 899

format approved by the Secretary of AHCA or designee. 900

3. In regards to the above thoracic and cardiovascular surgeons, since the 901

new Sub-Board of Pediatric and Congenital Cardiovascular Centers under 902

the American Board of Thoracic Surgery is now fully implemented, at 903


49

least one surgeon who started such training after July 1, 2008 must be 904

certified by this new Board within 5 years of becoming eligible. 905

4. Pediatric and congenital heart cardiac surgeons, either trained in other 906

countries or for any other reason not eligible for certification by the 907

American Board of Thoracic Surgery, or the new Sub-Board of Pediatric 908

and Congenital Cardiovascular Surgery, may be credentialed as an DOH 909

physician by the Surgeon General/Secretary of the Department of Health 910

or designee as a special situation after a review and in-depth evaluation by 911

the Pediatric Cardiac Technical Advisory Panel, which recommended such 912

approval. 913

5. Pediatric sub-specialists with expertise in hematology, nephrology, 914

neurology, infectious disease, critical care, genetics, gastroenterology and 915

pulmonology must be available for consultation and management of 916

patients with heart disease. 917

6. Radiologist trained in cardiopulmonary disease. 918

7. Anesthesiologist with training and experience in open and closed heart 919

pediatric anesthesia. 920

8. Respiratory Therapist with training and experience in short and long-term 921

ventilatory support in infants and children. 922


50

9. Technicians available 24 hours a day for laboratory and radiology 923

procedures. 924

10. At least one Perfusionist who is certified by the American Board of 925

Cardiovascular Perfusion in the area of cardiovascular perfusion. 926

Perfusion trainees must pump 40 cases to sit for the boards 927

Once they pass the boards, they must maintain 40 cases/year 928

plus CME every 2 years. 929

There is no distinction between pediatric versus adult 930

perfusionists in terms of case requirements. 931

Pediatric perfusionists must observe minimum of 10 pediatric 932

cases during their training. 933

11. Specially trained nurses for preoperative evaluation and instruction of the 934

patient and family, intensive care, and convalescent care. 935

12. Pathologist with skills and training in cardiovascular pathology. 936

13. The facility must identify and utilize a core surgical team. 937

14. Involved staff will make a priority of maintaining on-going 938

communication throughout the patient’s hospital course with the patient’s 939

primary care physician. 940


51

15. Continuous availability of a team skilled in performing intra-operative 941

TEE’s to aid in the post-surgical assessment of operative procedures. 942

16. Availability of Extra Corporeal Membrane Oxygenation (ECMO) 943

E. Pre-operative Preparation 944

1. Dedicated pediatric patient rooms with provision for a parent, relative or 945

guardian to remain overnight with hospitalized child. 946

2. Clear instructions to parents and patient with pre-operative visits to 947

catheterization laboratory, intensive care unit, and other sites as needed, 948

consistent with their ability to comprehend. 949

3. Care management conference between the pediatric cardiologist, pediatric 950

and congenital heart cardiac surgeon, and other professional staff as 951

necessary documented in the patient record. 952

F. Post-operative Care 953

1. All post-operative care must be under the direction of the involved DOH 954

credentialed cardiovascular surgeons in constant (24/7) communication with, 955

and in support of, the post-operative cardiovascular team composed of 956

pediatric intensivists, cardiologists, neonatologists, anesthesiologists, and 957

other personnel as needed. In certain cases, the involved pediatric and 958

congenital heart cardiac surgeon may transfer primary responsibilities to 959


52

another member of the team, such as cases with arrhythmias, or neonates on 960

Extra Corporeal Membrane Oxygenation (ECMO) in the neonatal intensive 961

care unit (NICU). 962

2. Each AHCA Pediatric and Congenital Cardiovascular Surgical Facility 963

must have a dedicated Pediatric and Congenital Cardiovascular Intensive Care 964

Unit with personnel specially trained in Congenital Heart Disease, including 965

physicians, nurses, respiratory specialists, and ancillary staff. Such a unit may 966

be either a separate cardiac ICU or a dedicated component within a Pediatric 967

Intensive Care Unit. 968

Guidelines for Pediatric Cardiovascular Centers: Pediatrics. 2002: Vol. 109 969

No. 3 544-549 970

G. Initial Evaluation 971

1. Program Evaluation and Development Review: When an initial request is 972

received for designation as an AHCA Pediatric and Congenital 973

Cardiovascular Center, along with attestation of compliance with all these 974

standards, a program evaluation and development review by members or 975

designees of the Pediatric Cardiac Technical Advisory Panel may be 976

scheduled at the request of the Hospital CEO and the Secretary of AHCA. 977

An application shall not be deemed complete until the Secretary of AHCA 978


53

or designee receives the recommendation of the Pediatric Cardiac 979

Technical Advisory Panel. 980

2. Medical Records Review: A minimum of 25 consecutive pediatric cardiac 981

surgical cases must be available within a specified time period to warrant 982

initial program evaluation and development review of any facility. 983

Facility Volume Standard: The minimum annual (12 consecutive 984

months) number of pediatric cardiac surgeries in a facility requesting to 985

become an AHCA Pediatric and Congenital Cardiovascular Center is 100 986

index cardiac operations as defined by Society of Thoracic Surgeons 987

(STS). Additionally, each center must do 90 open heart cases in a 12 988

month period, i.e. on Cardiopulmonary (CB) bypass. Open heart cases are 989

now counted by CMS criteria not STS criteria. Thus, multiple CB 990

operations, on the same patient during the same admission count 991

individually. Surgical Volume for Pediatric and Congenital Heart 992

Surgery: Total Programmatic Volume and Programmatic Volume 993

Stratified by Five STS-EACTS Mortality Levels: NATIONAL QUALITY 994

FORUM. Measure Evaluation 4.1 2009; 1-21. 995

Association of Center Volume With Mortality and Complications in 996

Pediatric Heart Surgery: Pediatrics 2012:129; e370-e376 997


54

998

An empirically based tool for analyzing mortality associated with congenital 999

heart surgery. The Journal of Thoracic and Cardiovascular Surgery. 2009: 1000

Vol. 138 No. 5; 1139-1153 1001

i) NATIONAL VOLUNTARY CONSENSUS STANDARDS FOR 1002

PEDIATRIC CARDIAC SURGERY: A CONSENSUS REPORT. 1003

National Quality Forum 2012: 1-18.For the purposes of counting 1004

cardiac surgical volume in an AHCA Pediatric and Congenital 1005

Cardiovascular Center, AHCA further defines pediatric cardiac 1006

surgeries to include the following: 1007

a) Cardiac Surgery: Cardiac surgical cases performed by each 1008

facility’s pediatric and congenital heart cardiac surgeon(s), 1009

including: 1010

1) Only cardiac operations count, as defined by the STS 1011

Congenital Heart Surgery Database as CPB (Cardio 1012

Pulmonary By-Pass) or No CPB Cardiovascular; 1013

2) Cardiac surgeries performed on pediatric patients (pediatric 1014

patient is defined by the Society of Thoracic Surgeons 1015

Database as from birth to 18 years of age); 1016


55

3) Cardiac surgeries performed on adult heart disease patients 1017

in whom the primary component is congenital; 1018

4) Non-cardiac surgeries performed on cardiopulmonary by-1019

pass by the facility’s pediatric and congenital heart cardiac 1020

surgeon(s); 1021

5) Surgical closure of a patent ductus arteriosus, including all 1022

premature infants, regardless of age; 1023

6) Placement of a cardiac pace-maker or defibrillator, in 1024

which the facility’s pediatric and congenital heart cardiac 1025

surgeon(s) is the implanting physician/surgeon; and 1026

7) Hybrid cardiac cases involving a surgical component. 1027

8) Heart transplantation and ventricular assist device 1028

placement in pediatric patients. 1029

b) Additionally, the following procedures are NOT considered 1030

when determining cardiac surgical volume: 1031

1) Cardiac surgeries not performed by the facility’s pediatric 1032

and congenital heart cardiac surgeon(s); 1033

2) Delayed sternal closure; 1034


56

3) Re-exploration of the mediastinum; for example, excessive 1035

bleeding; 1036

4) Operations where ECMO cannulation or decannulation is 1037

the primary procedure and any operations classified by the 1038

STS Congenital Heart Surgery Database as Operation Type 1039

= ECMO; and 1040

5) Any operation classified by the STS Congenital Heart 1041

Surgery Database as an Operation Type other than CPB 1042

(CPB = Cardio Pulmonary = By-Pass) or No CPB 1043

Cardiovascular. 1044

ii) To further clarify surgical volume for the purposes of AHCA 1045

volume requirements, surgical volume should be calculated based 1046

on each cardiac surgical admission that involves a cardiac surgical 1047

operation. For example, if patient A comes to the facility and has a 1048

cardiac operation and then has a second cardiac operation later but 1049

during the same admission, that would be counted as one surgery. 1050

FPAs, another example, if patient B has multiple component 1051

procedures performed during the same cardiac operation that 1052

would also be counted as one operation. Such guidelines are 1053


57

identical to the rules used by The Society of Thoracic Surgeons 1054

Database to calculate programmatic volume using index cardiac 1055

operations. AHCA utilizes such national standards whenever 1056

available. 1057

3. The facility must be co-located with an AHCA Pediatric Cardiology Clinic 1058

Facility and an AHCA Pediatric Catheterization facility. 1059

4. Facility Criteria: include all standards in the AHCA Pediatric and 1060

Congenital Cardiovascular Surgical Program Component section. If the 1061

facility is not in compliance with all the required criteria other than the 1062

volume standards, the facility must submit a corrective action plan for 1063

approval by the Secretary of AHCA or designee upon the 1064

recommendation of the Pediatric Cardiac Technical Advisory Panel. If the 1065

plan is approved, the facility shall be granted a one (1) year probationary 1066

status. Probationary status may be extended one (1) additional year if the 1067

facility documents improvements toward achieving all the facility criteria. 1068

If the facility is not in compliance with all the facility criteria at the end of 1069

a second year of probationary status, the facility shall be provided with a 1070

notice of intent to end the agreement between the AHCA Pediatric and 1071

Congenital Cardiovascular Center and the Agency. 1072


58

5. The Secretary of AHCA or designee considers new facilities for 1073

involvement upon the recommendation of the Cardiac Technical Advisory 1074

Panel and after fulfilling all criteria established above for pediatric cardiac 1075

surgery. The Secretary of AHCA or designee shall make the final 1076

decision on whether or not a facility may continue such an agreement with 1077

the Agency. 1078

H. Re-evaluation of Approved Facilities 1079

3. Facility Volume Standard: By the first and all subsequent three year 1080

program evaluation and development reviews, the minimum annual 1081

number of pediatric cardiac surgeries for a AHCA Pediatric and 1082

Congenital Cardiovascular Center is 101,at least 90 of which must be 1083

cases involving open heart surgery 1084

i) For the purposes of counting cardiac surgical volume in an AHCA 1085

Pediatric and Congenital Cardiovascular Center, AHCA further 1086

defines pediatric cardiac surgeries to include the following: 1087

a) Cardiac Surgery: Cardiac surgical cases performed by each 1088

facility’s pediatric and congenital heart cardiac surgeon(s), 1089

including: 1090


59

1) Only cardiac operations count, as defined by the STS 1091

Congenital Heart Surgery Database as CPB (Cardio 1092

Pulmonary By-Pass) or No CPB Cardiovascular; 1093

2) Cardiac surgeries performed on pediatric patients (pediatric 1094

patient is defined by the Society of Thoracic Surgeons 1095

Database as from birth to 18 years of age); 1096

3) Cardiac surgeries performed on adult patients in whom the 1097

primary cardiac component is congenital; 1098

4) Non-cardiac surgeries performed on cardiopulmonary by-1099

pass by the facility’s pediatric and congenital heart cardiac 1100

surgeon(s); 1101

5) Surgical closure of a patent ductus arteriosus, including all 1102

premature infants, regardless of age; 1103

6) Placement of a cardiac pace-maker or defibrillator, in 1104

which the facility’s pediatric and congenital heart cardiac 1105

surgeon(s) is the primary physician of record; and 1106

7) Hybrid cardiac cases involving a surgical component. 1107

8) Heart transplantation and placement ventricular assist 1108

device in pediatric patients. 1109


60

b) Additionally, the following procedures are NOT considered 1110

when determining cardiac surgical volume: 1111

1) Cardiac surgeries not performed by the facility’s pediatric 1112

and congenital heart cardiac surgeon(s); 1113

2) Delayed sternal closure; 1114

3) Re-exploration of the mediastinum; for example, excessive 1115

bleeding; 1116

4) Operations where ECMO cannulation or decannulation is 1117

the primary procedure and any operations classified by the 1118

STS Congenital Heart Surgery Database as Operation Type 1119

= ECMO; and 1120

5) Any operation classified by the STS Congenital Heart 1121

Surgery Database as an Operation Type other than CPB 1122

(CPB = Cardio-pulmonary = Bypass) or No CPB 1123

Cardiovascular. 1124

ii) To further clarify surgical volume for the purposes of AHCA 1125

volume requirements, surgical volume should be calculated based 1126

on each cardiac surgical admission that involves a cardiac surgical 1127

operation. For example, if patient A comes to the facility and has a 1128


61

cardiac operation and then has a second cardiac operation later but 1129

during the same admission, that would be counted as one surgery. 1130

As another example, if patient B has multiple component 1131

procedures performed during the same cardiac operation that 1132

would also be counted as one operation. Such guidelines are 1133

identical to the rules used by The Society of Thoracic Surgeons 1134

Database to calculate programmatic volume using index cardiac 1135

operations. CMS utilizes such national standards whenever 1136

available. 1137

i. 1138

4. If the facility volume is below 150, the facility shall be placed on 1139

probationary status for one (1) year. Probationary status may be extended 1140

one (1) additional year if the facility documents a positive trend in meeting 1141

the volume standard. If the facility has not achieved the volume standard 1142

at the end of a second year of probationary status, the facility shall be 1143

provided with a notice of intent to end the agreement between the AHCA 1144

Pediatric and Congenital Cardiovascular Center and the Agency. After a 1145

90 day transition period, the facility will receive a formal notice to end the 1146


62

agreement between the AHCA Pediatric and Congenital Cardiovascular 1147

Center and the Agency. 1148

5. Facility Criteria: include all standards, other than facility volume 1149

standards, in the AHCA Pediatric and Congenital Cardiovascular Surgical 1150

Program Component section. 1151

6. All AHCA Pediatric and Congenital Cardiovascular Centers must collect 1152

and submit the following quality assurance data to STS: 1153

Number of patients/ operations submitted and an analysis, operative 1154

mortality, and complexity information, by year 1155

Number of patients/operations in analysis, operative mortality, and 1156

complexity information, by age group 1157

Primary procedure outcomes, by anomaly 1158

STS-EACTS (STAT) Mortality Category Operative Mortality, by year 1159

STS-EACTS (STAT) Mortality Category Operative Mortality, by age 1160

group 1161

8. In the event that a facility’s participation with AHCA is terminated by 1162

either the facility or AHCA, a 90 day notice shall be provided to that AHCA 1163

Pediatric and Congenital Cardiovascular Center. 1164


63

9. The Secretary of AHCA or designee considers existing facilities for 1165

continued involvement upon the recommendation of the Pediatric Cardiac 1166

Technical Advisory Panel and fulfillment of all the criteria established above. 1167

The Secretary of AHCA or designee shall make the final decision as to 1168

whether or not to continue such an agreement with the Agency. 1169

VI. Advanced Congenital Cardiac Imaging 1170

i) Imaging modalities 1171

Advanced diagnostic imaging provides multi- dimensional imaging and 1172

quantitative data used to plan cardiac interventions. These modalities shall 1173

include, but are not limited to: 1174

a. Cardiac MRI, MRA with 3D reconstructions 1175

b. Cardiac Computed Tomography, CT angiography, 3D reconstructions, 1176

coronary CTA 1177

c. Pulmonary scintigraphy 1178

ii) Team Members: 1179

a. Physicians 1180

i. Physician in Charge: The physician in charge shall be a board 1181

certified radiologist or board certified pediatric trained cardiologist 1182

responsible for overseeing protocol development, adherence, 1183


64

staffing development, facility/equipment standards, and quality 1184

assurance processes for advanced imaging of congenital cardiac 1185

disease. 1186

ii. Physician Credentialing- Cardiac MRI, MRA: 1187

a. Radiology Track: Physician with board certification 1188

in radiology or within 2 years of radiology 1189

residency shall fulfill 2008 ACCF COCATS3 1190

requirements for Level 2 training specific to 1191

congenital cardiac MRI. 1192

b. Cardiology Track: Physician with board 1193

certification in Pediatric Cardiology or within 2 1194

years of training shall fulfill the 2008 ACCF 1195

COCATS3 requirements for Level 2 training in 1196

congenital cardiac MRI. 1197

2. MAINTENANCE: All physicians performing cardiac MRI 1198

examinations shall demonstrate evidence of continuing 1199

education and competence in the interpretation and 1200

reporting of MRI examinations. Continuing experience, 1201


65

interpretation or review of a minimum of 50 examinations 1202

every 3 years is required to maintain the physician’s skills. 1203

iii. Physician Experience Congenital Cardiac Computed 1204

1. Education in cardiac anatomy, physiology, pathology, and 1205

cardiac CT imaging for a time equivalent to at least 30 1206

hours of CME and including 1207

2. Physician with board certification in radiology or within 2 1208

years of radiology training shall fulfill 2008 ACCF 1209

COCATS3 requirements for Level 2 training specific to 1210

congenital cardiac CT. 1211

3. MAINTENANCE: Physicians performing cardiac CT 1212

examinations shall demonstrate evidence of continuing 1213

education and competence in the interpretation and 1214

reporting of cMRI examinations. Continuing experience, 1215

interpretation or review of a minimum of 50 examinations 1216

every 3 years is required to maintain the physician’s skills. 1217

iii) Facilities 1218

a. Testing environment 1219


66

The imaging environment shall be conducive to patient safety, comfort, 1220

and cooperation. 1221

b. Imaging equipment, software 1222

i. Cardiac MRI scanners shall be ACR accredited with equipment 1223

performance monitoring in accordance with state, federal 1224

requirements. 1225

ii. Cardiac MRI scanners shall have field strength of > 1.5 Tesla and 1226

equipped with localized multichannel radiofrequency surface coil 1227

and ECG gating. ECG gating capabilities shall include prospective 1228

triggering, retrospective gating, and triggered retrogating. 1229

iii. An MRI-compatible power injector is required for performing 1230

myocardial perfusion MR imaging or any MR angiographic 1231

methods. 1232

iv. The MRI scanner shall be capable of fast 3-D gradient-echo 1233

imaging, steady-state imaging with free precession, phase-contrast 1234

flow quantification, fast multi-slice myocardial perfusion imaging, 1235

and late contrast-enhanced myocardial imaging. Parallel imaging 1236

and half-Fourier capabilities are desirable to permit shortened 1237

breath-hold requirements. 1238


67

v. Commercial FDA-approved software for processing data 1239

(calculation of ejection fractions, reformatting angiographic data) 1240

shall be available either as part of the MRI system or on a separate 1241

workstation. Post-processing shall be performed or supervised by 1242

the cardiac MRI physician. 1243

c. Emergency equipment 1244

i. Appropriate emergency equipment and medications must be 1245

immediately available to treat adverse reactions associated with 1246

administered medications. 1247

ii. The equipment and medications shall be monitored for inventory 1248

and drug expiration dates on a regular basis. The equipment, 1249

medications, and other emergency support must be appropriate for 1250

the range of ages and sizes in the patient population. 1251

1252

iv) Records and archive requirements 1253

a. Reporting shall be available in the electronic medical records in 1254

accordance to facility reporting timelines. 1255

v) A quality improvement process shall be utilized to evaluate for completeness, 1256

correlation and accuracy. 1257


68

1258 Sources: Baughman et al. ACCF COCATS3 Training Statement JACC 2008. 1259

1260

ACR–NASCI–SPR PRACTICE PARAMETER FOR THE PERFORMANCE AND 1261

INTERPRETATION OF CARDIAC MAGNETIC RESONANCE IMAGING (MRI). 1262

Revised 2016 (Resolution 5)* 1263

1264

1265

Documents

Agency for Health Care Administration Pediatric and Congenital Cardiovascular Center ... · 2018-12-11 · Pediatric and Congenital Cardiovascular Center Standards September 2018