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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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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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
46
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
361
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
379
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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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
2012 American College of Cardiology Foundation/Society for 467
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
2012 American College of Cardiology Foundation/Society for 477
Cardiovascular Angiography and Interventions Expert Consensus 478
Pediatric and Congenital Cardiovascular Center Standards September 2018
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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
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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
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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
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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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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
Pediatric and Congenital Cardiovascular Center Standards September 2018
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