Agency for Health Care Administration Pediatric ......Pediatric Cardiovascular Center Standards...
Transcript of Agency for Health Care Administration Pediatric ......Pediatric Cardiovascular Center Standards...
Pediatric Cardiovascular Center Standards
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Agency for Health Care Administration 3
Pediatric Cardiovascular Center Standards 4
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Agency for Health Care Administration (AHCA) Pediatric Cardiovascular Centers 8
undergo a quality assurance process that ensures such Pediatric Cardiovascular Centers 9
(PCVC) meet established minimum standards deemed necessary for the provision of 10
quality cardiac services to children with special health care needs. CMS encourages the 11
creation of policies to foster growth of centers of excellence. 12
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The following standards are required for entering into, and continuing in, an agreement 14
with AHCA as a PCVC. An AHCA Pediatric Cardiovascular Center will consist of the 15
following co-located components: 16
I. Pediatric Cardiology Clinic 17
II. Pediatric Cardiac Catheterization Laboratory 18
III. Pediatric Cardiac Electrophysiology (EP) Program 19
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IV. Pediatric Cardiovascular Surgery Program 21
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An AHCA Pediatric Cardiovascular Center must provide care for all (PCVC) enrolled 23
individuals with congenital and acquired heart disease who require such expertise. For 24
volume standard purposes, “pediatric cardiac” cases include children with congenital and 25
acquired heart disease under age 21 years and adults 21 years or older with congenital 26
heart disease. 27
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For the purposes of AHCA Pediatric Cardiovascular Center program evaluation, 29
development and review, each distinct facility component will be surveyed individually 30
within a multi-site Pediatric Cardiovascular Center. Each of its individual components 31
must meet or exceed AHCA standards; that is, each hospital-based team must perform the 32
minimum number of echocardiograms, catheterizations, electrophysiologic studies and 33
surgeries specified herein. Each component in the AHCA Pediatric Cardiovascular 34
Center shall be evaluated based on its own merits. 35
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All AHCA Pediatric Cardiovascular Centers must: 37
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1. Be located within a healthcare facility that maintains accreditation by the Joint 38
Commission on Accreditation of Healthcare Organizations (JCAHO) and/or the 39
National Committee for Quality Assurance (NCQA). 40
2. Be HIPAA (Health Insurance Portability and Accountability Act) compliant. 41
3. Provide limited English proficiency services, in accordance with Federal 42
guidelines. 43
4. Have quality assurance and quality improvement processes in place that 44
continuously enhance the clinical operation and patient satisfaction with services. 45
5. Collect and submit quality assurance data annually in accordance with the 46
following CMS forms: 47
Pediatric Cardiology Clinic Laboratory Procedures (DH-CMS 2056, 48
10/20XX) 49
Pediatric Cardiac Catheterization Procedures (DH-CMS 2057, 10/20XX) 50
Cardiac Catheterization Cases--Primary Cardiac Diagnoses (DH-CMS 2058, 51
10/20XX). 52
Patients with Fetal Diagnosis of Heart Conditions (DH-CMS 2065, 10/20XX) 53
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The above forms are hereby adopted and incorporated by reference. All forms 55
adopted and incorporated by reference in these standards are available upon 56
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request from Agency for Health Care Administration, 2727 Mahan Drive, 57
Tallahassee, Florida 32308. 58
6. Actively participate in the Society of Thoracic Surgeons (STS) Congenital Heart 59
Surgery Database. 60
7. Participate in the STS Congenital Heart Surgery Database Anesthesia Module. 61
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8. Participate in the Improving Pediatric and Adult Congenital Treatments 63
(IMPACT) database. 64
9. Collect and submit the following quality assurance data annually, from their 65
annual STS Congenital Heart Surgery Database Report: 66
Number of patients/operations submitted and an analysis of discharge 67
mortality, and complexity information, by year 68
Aristotle Basic Complexity Level Discharge Mortality, by year 69
Risk-Adjusted Congenital Heart Surgery (RACHS)-1 Discharge Mortality, by 70
year 71
Number of patient/operations in analysis, discharge mortality, and complexity 72
information, by age group 73
Aristotle Basic complexity Level Discharge Mortality, by age group 74
RACHS-1 Discharge Mortality, by age group 75
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Primary Procedure Discharge Mortality based on Aristotle Basic Complexity 76
Score, sorted by anomaly 77
STS-EACTS (European Association of Cardio-Thoracic Surgery) Mortality 78
Category Discharge Mortality, by year 79
STS-EACTS Mortality Category Discharge Mortality, by age group 80
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All AHCA Pediatric Cardiovascular Centers must implement electronic medical record 82
technology. 83
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All AHCA Pediatric Cardiovascular Centers with birthing centers must have a neonatal 85
screening program using pulse oximetry to detect critical congenital heart disease. 86
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A multidisciplinary cardiac team must include pediatric cardiology, cardiovascular 88
surgery, cardiovascular anesthesia, nursing, ancillary and support staff associated with 89
pre-operative patient selection and preparation, the surgical or catheterization procedure, 90
and post-operative care and follow-up. 91
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All physicians and other licensed healthcare professionals that require credentialing 93
through the Department of Health (DOH) or the Department of Professional Regulations 94
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(DPR) credentialing process and are providing care at a AHCA Pediatric Cardiovascular 95
Center must be CMS credentialed providers, as specified in rule 64C-4.001 Florida 96
Administrative Code (F.A.C.). 97
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Facilities requesting to be involved as a AHCA Pediatric Cardiovascular Center must 99
submit a formal request to the Secretary of AHCA or designee at 2727 Mahan Drive, 100
Tallahassee, Florida 32308. 101
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I. Standards for AHCA Hospital Co-located Pediatric Cardiology Clinic 103
A. The hospital pediatric cardiology clinic must be co-located with a AHCA 104
Pediatric Cardiac Catheterization Laboratory. 105
B. All echocardiography laboratories performing Transthoracic Echoes (TTE), 106
Trans Esophageal Echoes (TEE) and Fetal Echoes (FE) must be accredited by 107
the Intersocietal Accreditation Commission (IAC) prior to their initial or 108
subsequent program evaluation and development review. 109
C. A pediatric cardiology clinic must be able to perform diagnostic evaluations 110
including, but not limited to, echocardiographic recording, Holter monitoring, 111
exercise testing, and serial pacemaker monitoring. They must either be able to 112
perform fetal echocardiograms or have access to a fetal echocardiography 113
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facility. Each center must annually perform at least 50 procedures each for 114
Holter monitor recordingsand serial pacemaker monitoring procedures. Each 115
center must annually perform at least 50 exercise testing studies. 116
D. Fetal echocardiograms performed by a physician outside the physical 117
boundaries of an IAC approved facility may be counted toward the required 118
Facility Volume Standards so long as all of the following criteria are met: 119
1. The physician performing the fetal echocardiogram is on the medical staff of 120
the hospital facility and affiliated with the hospital’s pediatric cardiology 121
program; 122
2. The physician performing the fetal echocardiogram is a credentialed 123
physician; 124
3. The program provides evidence that the physician maintains appropriate 125
times of operation and protocols, including proper affiliation agreements to 126
ensure availability and appropriate referrals in the event of emergencies; and 127
4. The fetal echocardiographic laboratory is accredited by IAC. 128
E. Cardiology Clinic Components 129
1. Pediatric Cardiology Clinic: 130
i) Physicians – The physician in charge of a Pediatric Cardiology Clinic 131
must be board-certified by the Sub-board of Pediatric Cardiology of 132
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the American Board of Pediatrics. Recertification or maintenance of 133
competency (MOC) certificates of such a physician will be an integral 134
component of all future program evaluation and development reviews. 135
Board eligibility as an equivalent for board certification will not be 136
considered as a criterion for credentialing beyond 5 years of eligibility 137
unless a specific exception is made by the Secretary of AHCA or 138
designee. 139
ii) Nurse - A registered nurse who has expertise with cardiac problems in 140
children must participate in each cardiac clinic. 141
iii) Social Worker or another individual capable of performing social 142
service functions. 143
2. Echocardiography Laboratory: 144
i) A physician who is board certified in pediatric cardiology. 145
ii) A sonographer who is a Registered Diagnostic Cardiac Sonographer 146
(RDCS), American Registry of Diagnostic Medical Sonographers 147
(ARMDS), or Registered Cardiovascular Technologist (RCVT) 148
pediatric certified. 149
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iii) The echocardiography laboratory workstation must include a study 150
review area with dictation capabilities, and supplies and equipment 151
necessary for compilation and analysis of echocardiographic studies. 152
3. Holter Monitoring Laboratory: 153
A physician who is board certified in pediatric cardiology. 154
4. Exercise Treadmill Laboratory: 155
i) A physician who is board certified in pediatric cardiology. 156
ii) A Basic Life Support (BLS) certified cardiology technologist or 157
respiratory care practitioner. 158
iii) Pediatric Advanced Life Support (PALS) trained personnel available 159
in-house. 160
iv) The exercise treadmill lab must include a remote “code” button and 161
telephone. 162
v) Each center should have access to a metabolic exercise laboratory, in 163
which oxygen utilization and the anaerobic threshold can be 164
determined, as an adjunct to detecting early failing cardiopulmonary 165
function. 166
vi) All PCVC institutions should follow the guidelines set forth in the 167
American Heart Association Scientific Statement on "Clinical Stress 168
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Testing in the Pediatric Age Group" (Circulation. 2006; 113:1905-169
1920). 170
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vii) Specifically, as a PCVC requires that involved institutions: 172
S 173
a) Maintain an appropriate pediatric exercise physiology 174
laboratory, including 175
1) Age- and size-appropriate treadmill and/or cycle ergometer 176
2) Age- and size-appropriate blood pressure cuffs 177
3) Age- and size-appropriate oxygen saturation monitor 178
4) EKG recording equipment 179
5) An emergency resuscitation cart that includes emergency 180
drugs, a defibrillator, supplemental oxygen, and a portable 181
suction unit 182
6) A log demonstrating periodic testing of the defibrillator and 183
oxygen supply, and periodic inspection of emergency drug 184
expiration dates 185
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b) Conduct all stress tests with at least one person trained in 186
pediatric advanced life support (PALS) in the room at all times 187
with the patient during the test 188
c) Conduct all stress tests with a physician immediately available 189
(i.e. in the building) 190
d) Perform a minimum of 50 pediatric exercise stress tests per 191
year 192
e) Obtain meaningful written consent for the stress test (which 193
may be a hospital-wide standard consent form filled out 194
specifically for stress testing) 195
viii) PCMS institutions are recommended to: 196
a) Have oversight of the laboratory and testing procedures 197
provided by a physician trained in exercise testing and exercise 198
physiology 199
b) Be able to perform spirometry/pulmonary function testing 200
c) Be able to perform metabolic stress tests 201
d) Be able to perform or refer patients for stress echocardiography 202
e) Be able to perform or refer patients for pharmacologic stress 203
testing 204
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f) Be able to perform or refer patients for nuclear myocardial 205
blood flow imaging 206
5. Serial monitoring and management of implanted electronic devices, such 207
as pacemakers and defibrillators should be an integral component of any 208
center. 209
6. Adult Congenital Heart Clinic- Each PCVC Pediatric Cardiology Clinic 210
must have a specific adult congenital heart clinic, listed by the Adult 211
Congenital Heart Association (ACHA). Such a clinic should have a 212
physician clinic director with special skills and expertise in dealing with 213
adults with congenital heart disease. 214
7. Adult Congenital Heart Programs: 215
i) All adults with congenital heart disease deserve access to 216
appropriate care. 217
ii) Each CMS Pediatric Cardiovascular Center must have as a goal to 218
provide care in alignment with national standards, utilizing as 219
guidelines those of the Adult Congenital Heart Association 220
(ACHA). 221
iii) More self-sustaining comprehensive Adult Congenital Heart 222
Programs (ACHP) will be needed to provide such type of care in 223
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the future. Collaboration among AHCA Pediatric Cardiovascular 224
Centers with some regionalization of expertise is encouraged. 225
iv) Existing national and international guidelines, which outline the 226
care provided in adult congenital heart programs, should be 227
utilized. 228
v) All ACHD programs must be registered with the Adult Congenital 229
Heart Association and submit required data at established intervals. 230
vi) Personnel 231
a) The program must be directed by a physician with special skills 232
and training in caring for the adult patient with congenital heart 233
disease. 234
b) A primary goal of each ACHD program is that the Director of 235
the ACHD program be board certified by the ABP/ABIM 236
ACHD sub-board within five years of the initial examination. 237
c) Cardiac Surgeon(s) with expertise in the unique surgical 238
aspects and challenges of the adult congenital heart patient. 239
d) Social Worker who is available to the adult patient to provide 240
counseling and support services. 241
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e) A health professional (ARNP or PA) whose role includes 242
coordinating care for ACHD patients. 243
f) Availability of Adult Medicine sub-specialty physicians to 244
provide consultative care. 245
g) All physicians caring for the adult congenital heart disease 246
patient be ACLS certified. 247
h) All staff performing exercise testing on adult congenital heart 248
disease patient be ACLS certified. 249
vii) Clinic Physical Space 250
a) The clinic space used for evaluation of adult patients must be 251
in accordance with their specific needs. 252
b) Facility must be accessible to handicapped Individuals. 253
c) Availability of EKG, X-Rays, MRI studies, Echocardiography, 254
and exercise/metabolic stress testing 255
d) Availability of a conference room for multi-disciplinary 256
meetings. 257
viii) Hospital and Inpatient Facilities 258
a) The admitting facility must have expertise in the care of this 259
complex adult congenital heart patient population. 260
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b) The ACHD Program must have access to a fully equipped 261
cardiac laboratory with appropriately trained personnel. 262
c) The ACHD Program must meet national standards in all 263
cardiac catheterization interventional and electrophysiology 264
procedures. 265
d) The ACHD Program must offer a comprehensive 266
cardiovascular surgical program, with established commitment 267
from cardiac intensivists, anesthesiologists, and other adult 268
medical and surgical subspecialties. 269
ix) Patient Care Characteristics Specific to an ACHD Program – 270
Recommendations and Specific Requirements: 271
a) Patient care transition services must be emphasized during 272
patient encounters. Transition education of the pediatric 273
patient should start at age 12 years and should be documented 274
in clinic notes. Such transition programs should be coordinated 275
with the Agency for Health Care Administration transition 276
program where available. 277
b) All adult patients (18 years or older) must be referred for an 278
initial evaluation by an adult congenital heart specialist. 279
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c) Adult female patients with congenital heart disease must have 280
access to professional staff expert in the management of 281
contraception and pre-pregnancy counseling. In addition, 282
Genetic Counseling and Fetal Echocardiography studies must 283
be available. 284
d) Pregnant patients with congenital heart disease must be 285
evaluated as a High-Risk Pregnancy and referred to Maternal-286
Fetal Medicine Physicians. 287
e) Health maintenance programs for adolescents and adult 288
patients with CHD should be initiated by providing each 289
patient with information related to, but not limited, to 290
recommendations on endocarditis prophylaxis, anticoagulation 291
therapy, diet, weight control, contraception, pregnancy risk and 292
exercise limitations. 293
f) There must be a major educational component that forms the 294
foundation of the ACHD program that will advance public 295
awareness, educate the medical and health care community and 296
empower those individuals with adult CHD to have 297
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opportunities to be successful contributing adults to their 298
respective communities. 299
g) The ACHD program is strongly encouraged to develop 300
partnership with sister institutions to do collaborative research, 301
cultivate working relationships and form advocacy groups to 302
support their patients with CHD. These partnership building 303
activities should aim to address the critical issues in ACHD 304
patients and aid in achieving health equity for all such adult 305
patients with congenital heart disease. 306
8. Annual updates on information submitted by each center to the ACHA 307
regarding adult congenital heart disease activities should be forwarded to 308
the AHCA program staff within 30 days of such submission. 309
9. High Risk Obstetrical Cases with Fetal Cardiac Anomalies- Each AHCA 310
Pediatric Cardiovascular Center must have an established protocol to 311
address the needs of such patients, usually high-risk obstetrical cases 312
having a cardiac fetal anomaly diagnosed by fetal echocardiography 313
and/or ultrasound. 314
F. Physical Facility General requirements: 315
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1. The area must be suitable for performance of a high quality cardiovascular 316
examination. 317
2. Examination areas must be adequately lighted, have adjustable 318
temperature, and offer privacy to patients. 319
3. A conference room must be available for discussing cases. 320
G. Equipment - All clinic equipment must be monitored and maintained in 321
accordance with manufacturers’ recommendations. 322
H. Radiological equipment- Access to a Radiological facility at which chest x-323
rays and other indicated radiological studies can be expeditiously performed, 324
including access to Magnetic Resonance Imaging (MRI) studies, particularly 325
to evaluate the large vessels of the chest associated with the heart. 326
I. Records 327
1. Permanent record of real time study must include, at a minimum, video, 328
disk, chart, or digital or electronic medical records. 329
2. Permanent record of real time study of Holter Monitoring studies must 330
include one or more of the following: cassette tape, disk, printed paper, 331
or digital or electronic medical records. 332
3. Permanent record of real time study of exercise treadmill testing must 333
include EKG and blood pressure recordings. 334
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4. Permanent record of real time study of serial pacemaker testing must be 335
available. 336
5. Interpretation and final approval of study reports must be performed by a 337
physician who is board certified in pediatric cardiology. 338
6. Medical records must be retained for a period of no less than seven (7) 339
years in a locked area. 340
J. Initial Evaluation 341
1. Program evaluation and development review: When a request is received 342
for involvement as a PCVC Hospital co-located Pediatric Cardiology 343
Clinic, along with attestation of compliance with these standards, a 344
program evaluation and development review by members or designees of 345
the AHCA Cardiac Technical Advisory Panel will be scheduled. A 346
request for involvement shall not be deemed complete until the Secretary 347
of AHCA or designee receives the recommendation of the AHCA 348
Cardiac Technical Advisory Panel. 349
2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 350
cases within a specified time period must be available to warrant initial 351
evaluation of any facility. 352
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3. Facility and Practitioner Volume Standards: A facility requesting to 353
participate as a Pediatric Cardiovascular Center must meet requirements 354
for and have documentation of IAC accreditation. 355
4. Facility Criteria: include all standards in the PCVC Hospital co-located 356
Pediatric Cardiology Clinic Component section. 357
5. The Secretary of AHCA or designee considers new facilities for upon the 358
recommendation of the PCTAP and the criteria established above. The 359
Secretary of AHCA or designee shall make the final decision on whether 360
a facility may participate by entering into an agreement with the Agency 361
for Health Care Administration. 362
K. Re-evaluation of CMS Pediatric Cardiovascular Centers 363
1. Program Evaluation and Development Review: Each Hospital co-located 364
Pediatric Cardiology Clinic must be re-evaluated at a minimum of once 365
every three (3) years on-site by members or designees of the PCTAP. The 366
re-evaluation process is not complete until the Secretary of AHCA or 367
designee receives the recommendation of the PCTAP. 368
2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 369
cases within a specified time period must be available for review at the 370
time of the re-evaluation. 371
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3. Facility and Practitioner Volume Standards: Meets requirements for IAC 372
accreditation. 373
If all IAC requirements are not met, the facility shall be placed on 374
probationary status for one (1) year. Probationary status may be extended 375
one (1) additional year if the facility documents a positive trend in meeting 376
the volume standards. If the facility has not achieved the volume 377
standards necessary for IAC accreditation at the end of a second year of 378
probationary status, the facility shall be provided with a notice of intent to 379
end the agreement between the Pediatric Cardiovascular Center and 380
AHCA as a participating Pediatric Cardiovascular Center. 381
4. IAC Accreditation: By the initial or subsequent program evaluation and 382
development review, all echocardiography laboratories, TTE, TEE, and 383
FE must be accredited by the IAC, whether within the center or “off-site”. 384
5. Facility Criteria: include all standards in the PCVC Hospital co-located 385
Pediatric Cardiology Clinic Component section. If all facility criteria 386
other than volume standards are not met, the facility must submit a 387
corrective action plan for approval by the Secretary of AHCA or 388
designee, upon the recommendation of the PCTAP. If the plan is 389
approved, the facility shall be granted a one (1) year probationary status. 390
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Probationary status may be extended one (1) additional year if the facility 391
documents improvements toward achieving all the facility criteria. If the 392
facility is not in compliance with all the facility criteria at the end of a 393
second year of probationary status, the facility shall be provided with a 394
notice of intent to end the agreement between the Pediatric Cardiovascular 395
Center and the Agency of Health Care Administration. After a 90-day 396
transition period, the facility will receive formal notice of the end of the 397
agreement between the Pediatric Cardiovascular Center and AHCA. 398
6. Data Submission: All Pediatric Cardiology Clinics must collect and 399
submit quality assurance data annually in accordance with the following 400
CMS form: 401
Pediatric Cardiology Clinic Laboratory Procedures (DH-CMS 2056, 402
10/20XX) 403
7. In the event that a facility’s participation with AHCA is terminated by 404
either the facility or Agency, a 90 day notice shall be provided to the 405
Pediatric Cardiovascular Center. 406
The Secretary of AHCA or designee considers existing facilities for 407
continuing involvement upon the recommendation of the PCTAP and the 408
criteria established above. The Secretary of AHCA or designee shall 409
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make the final decision on whether or not a facility by continue such an 410
agreement with the Agency. 411
II. Standards for AHCA Pediatric Cardiac Catheterization Laboratory 412
Component 413
A. The Pediatric Cardiac Catheterization Laboratory must be co-located within 414
a facility completely equipped to accommodate all aspects of the medical 415
and surgical care of the patient. 416
417
2012 American College of Cardiology Foundation/Society for 418
Cardiovascular Angiography and Interventions Expert Consensus Document 419
on Cardiac Catherization Laboratory Standards Update. J Am College 420
Cardiology. 2012;Vol. 59 No. 24 221-2305. 421
B. Cardiac Team 422
1. Physician in Charge 423
The physician in charge of the procedure must be board-certified by the 424
Sub-Board of Pediatric Cardiology of the American Board of Pediatrics. 425
Pediatric cardiologists either trained in other countries or for any reason 426
not eligible for certification by the Sub-Board of Pediatric Cardiology of 427
the American Board of Pediatrics may be credentialed as a AHCA 428
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physician by the Secretary of AHCA or designee, as a special situation 429
after a review and in-depth evaluation by the Pediatric Cardiac Technical 430
Advisory Panel, which recommended such approval. 431
2. Consulting Physicians 432
In addition to the physician listed above, in interventional cardiac 433
catheterizations, an anesthesiologist and a thoracic surgeon, each with 434
advanced training in the cardiovascular aspects of their specialty, must be 435
immediately available within the facility or in close proximity for 436
consultation, assistance, emergency and elective surgical procedures and 437
peri-operative care. 438
3. Nurse 439
Each laboratory must have a registered nurse, with special training in 440
cardiovascular techniques and in the care of children, as a full time 441
member of the team. This nurse must have special skills in pre-442
catheterization evaluation and instruction of the patient and family, care of 443
the patient post-catheterization, and discharge teaching for the patient and 444
family. 445
4. Cardiovascular Technologist 446
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Each laboratory must have a cardiovascular technologist with special 447
training in cardiac catheterization laboratory techniques. 448
5. Dedicated Trained Cardiovascular Recorder 449
Each laboratory must have a dedicated trained cardiovascular recorder 450
who has no other responsibilities during procedures. 451
6. Each laboratory must have immediate access to personnel trained in 452
equipment repair and maintenance. 453
7. Although the above required functions are well defined, it is not necessary 454
for one person to fulfill each separate job category. Well defined adequate 455
cross training for other personnel classifications permits 24-hour coverage 456
of essential team functions. 457
8. All technologists in a cardiovascular laboratory must be certified by the 458
Cardiovascular Credentialing Institute as a Registered Cardiovascular 459
Technologist (RCVT) and licensed by the State of Florida under the 460
Clinical Laboratory law, when applicable. 461
C. Equipment: Radiological, electronic, and computer-based systems are integral 462
components of the equipment in a catheterization laboratory. These systems 463
all require a program of rigorous maintenance and troubleshooting. For 464
pediatric patients, biplane angiography, higher framing rates (30-60 fps), and 465
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higher injection rates (up to 40 mL/s) are required to help define abnormal 466
intra-cardiac anatomy. 467
2012 American College of Cardiology Foundation/Society for Cardiovascular 468
Angiography and Interventions Expert Consensus Document on Cardiac 469
Catherization Laboratory Standards Update. J Am College Cardiology. 470
2012;Vol. 59 No. 24 221-2305. 471
D. Electrical Safety and Radiation Protection 472
Electrical safety and radiation protection shall be followed in accordance with 473
the manufacturer’s recommendations and applicable State and Federal 474
regulations. 475
E. Records 476
1. Permanent record of real time study must include, at a minimum, video, 477
disk, chart, or digital / electronic recordings. 478
2. Interpretation and final approval of study reports must be performed by a 479
physician who is board certified in pediatric cardiology. 480
3. Medical records must be retained for a period of no less than seven (7) 481
years in a secure locked area. 482
F. Initial Evaluation 483
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1. Program Evaluation Review: When a request is received for participation 484
as an AHCA Pediatric Cardiac Catheterization Laboratory facility, along 485
with attestation of compliance with all these standards, a program 486
evaluation and development review by members or designees of the 487
Cardiac Technical Advisory Panel will be scheduled as the final 488
component of the application process. A request for participation shall not 489
be deemed complete until the Secretary of AHCA or designee receives the 490
recommendation of the PCTAP. 491
2. Medical Records Review: A minimum of 25 consecutive pediatric cardiac 492
catheterization cases within a specified time period must be available to 493
warrant initial program evaluation and development review of any facility. 494
3. Facility Volume Standards: The minimum annual number of pediatric 495
cardiac catheterizations in a facility requesting to participate as an AHCA 496
Pediatric Cardiovascular Center is 150 per facility (with a minimum of 50 497
interventional). 498
2012 American College of Cardiology Foundation/Society for 499
Cardiovascular Angiography and Interventions Expert Consensus 500
Document on Cardiac Catherization Laboratory Standards Update. J Am 501
College Cardiology. 2012;Vol. 59 No. 24 221-2305. 502
Deleted: 503
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4. Practitioner Volume Standards: The minimum annual number of pediatric 504
cardiac catheterizations performed by each practitioner in a facility 505
requesting to participate as a AHCA Pediatric Cardiovascular Center is 50 506
per year. Practitioners doing interventional procedures must do a 507
minimum of 25 interventional catheterizations per year. 508
2012 American College of Cardiology Foundation/Society for 509
Cardiovascular Angiography and Interventions Expert Consensus 510
Document on Cardiac Catherization Laboratory Standards Update. J Am 511
College Cardiology. 2012;Vol. 59 No. 24 221-2305. 512
5. Facility Criteria: include all standards in the AHCA Pediatric Cardiac 513
Catheterization Laboratory Component section. 514
6. The Secretary of AHCA or designee considers new facilities for 515
involvement upon the recommendation of the Pediatric Cardiac Technical 516
Advisory Panel (PCTAP) and all the criteria established above for 517
pediatric cardiac catheterizations. The Secretary of AHCA or designee 518
shall make the final decision on whether or not a facility may continue 519
such entering into an agreement with the Agency. 520
G. Re-evaluation of AHCA Facilities 521
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1. Program Evaluation and Development Review: Each AHCAPediatric 522
Cardiac Catheterization Laboratory Facility must be evaluated on-site by 523
members or designees of the Pediatric Cardiac Technical Advisory Panel 524
at a minimum of once every three (3) years. The re-evaluation process is 525
not complete until the Secretary of AHCA or designee receives the 526
recommendation of the Pediatric Cardiac Technical Advisory Panel. 527
2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 528
catheterization cases must be available within a specified time period for 529
review at the time of the re-evaluation. 530
Facility Volume Standards: The minimum annual number of cardiac 531
catheterizations in a AHCA Pediatric Cardiovascular Center is 150 per 532
facility (with a minimum of 50 interventional). If the facility volume is 533
below 150 for the twelve (12) month reporting period, the facility shall be 534
placed on probationary status for one (1) year. Probationary status may be 535
extended one (1) additional year if the facility documents a positive trend 536
in meeting the volume standard. If the facility has not achieved the 537
volume standard at the end of a second year of probationary status, the 538
facility shall be provided with a notice of intent to end the agreement 539
between the AHCA Pediatric Cardiovascular Center and the Agency. 540
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3. Practitioner Volume Standards: By the first or subsequent three-year 541
program evaluation and development review, the minimum number of 542
cardiac catheterizations performed by each practitioner in a AHCA 543
Pediatric Cardiovascular Center is 50 per year. Practitioners doing 544
interventional procedures must do a minimum of 25 interventional 545
catheterizations per year. 546
4. Facility Criteria: include all standards, other than facility volume 547
standards, in the AHCA Pediatric Cardiac Catheterization Laboratory 548
Component section. 549
If the facility is not in compliance with all the required criteria other than 550
the volume standards, the facility must submit a corrective action plan for 551
approval by the Secretary of AHCA or designee upon the recommendation 552
of the Pediatric Cardiac Technical Advisory Panel. If the plan is 553
approved, the facility shall be granted one-year probationary status. 554
Probationary status may be extended one (1) additional year if the facility 555
documents improvements toward achieving all the facility criteria. If the 556
facility is not in compliance with all the facility criteria at the end of a 557
second year of probationary status, the facility shall be provided with a 558
notice of intent to end the agreement between the AHCA Pediatric 559
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Cardiovascular Center and the Agency. After the 90 day patient care 560
transition period, the facility will receive formal notice of the end of the 561
agreement between the AHCA Pediatric Cardiovascular Center and the 562
Agency. 563
5. Data Submission: All AHCA Pediatric Cardiac Catheterization 564
Laboratories must collect and submit quality assurance data annually in 565
accordance with the following forms: 566
Pediatric Cardiac Catheterization Procedures (DH-CMS 2057, 567
10/20XX); and 568
Cardiac Catheterization Cases--Primary Cardiac Diagnoses (DH-569
CMS 2058, 10/20XX). 570
6. In the event that a facility’s participation with AHCA is terminated by 571
either the facility or AHCA, a 90 day notice shall be provided to the 572
AHCA Pediatric Cardiovascular Center. 573
7. The Secretary of AHCA or designee considers existing facilities for 574
continuing involvement based upon the recommendation of the Pediatric 575
Cardiac Technical Advisory Panel and all the criteria established above. 576
The Secretary of AHCA or designee shall make the final decision on 577
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whether or not a facility may continue such an agreement with the 578
Agency. 579
580
III. Standards for AHCA Pediatric Cardiac Electrophysiology (EP) Programs 581
A Pediatric Cardiac Electrophysiology (EP) Program is an integral part of a 582
AHCA Pediatric Cardiovascular Center. The EP program has two main 583
components: (1) An Interventional program in a Pediatric Cardiac 584
Electrophysiology Laboratory and (2) an outpatient arrhythmia evaluation and 585
management service. 586
An institution participating as a AHCA Pediatric Cardiovascular Center, may 587
elect not to participate in both components of these EP Standards. 588
All AHCA designated centers must participate in the outpatient arrhythmia 589
evaluation and management services. 590
If an institution elects not to participate in the EP interventional program in a 591
pediatric cardiology electrophysiology laboratory, it must have a written 592
format establishing an effective triage to another AHCA EP facility as defined 593
below. Such a protocol must include a formal document signed by the CEO’s 594
of both involved institutions and approved by the Secretary of AHCA or 595
designee. 596
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597
A. Laboratory Component: The Pediatric Cardiac Electrophysiology Laboratory 598
must be co-located within a facility completely equipped to accommodate all 599
aspects of the medical and surgical care of the pediatric patient. 600
1. Cardiac Team 601
i) Physician in Charge: The physician in charge of the laboratory must be 602
board-certified by the Sub-Board of Pediatric Cardiology of the 603
American Board of Pediatrics and must be a pediatric 604
electrophysiologist as defined below: 605
a) Pediatric Electrophysiologist is a Pediatric Cardiology Board 606
Certified physician, whose primary clinical practice is dedicated to 607
pediatric electrophysiology activities. 608
b) In addition, the individual to be credentialed by AHCA as a 609
pediatric electrophysiologist must meet the International Board of 610
Heart Rhythm Examiners (IBHRE) board eligibility criteria by 611
meeting or exceeding the requirements outlined by one or both of 612
the tracks outlined below: 613
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International Board of Heart Rhythm Examiners. Eligibility 614
Requirements Policy: IBHRE Board Certification Examination in 615
Cardiac Electrophysiology for the Physician 10.29.2010 616
Pediatric Electrophysiologist: Credentials 617
1) Track 1: Training Completed After July 1, 2005 618
(i) Successful completion of a pediatric cardiovascular 619
medicine fellowship program and board-certified in 620
Pediatric Cardiology by the American Board of Pediatrics. 621
(ii) Successful completion of a minimum of 1 additional year 622
of cardiac electrophysiology training in a pediatric 623
electrophysiology fellowship program. The training 624
program must meet the minimum criteria set forth by the 625
task force in pediatric cardiology training. ACCF/AHA/AAP 626
Recommendations for Training in Pediatric Cardiology. 627
A Report of the American College of Cardiology 628
Foundation/American Heart Association/American 629
Committee to Develop Training Recommendations for 630
Pediatric Cardiology) College of Physicians Task Force on 631
Clinical Competence Circulation. 2005;112:2555-2580 632
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(iii)In addition, the electrophysiologist must monitor on a 633
continuing basis at least 30 patients with implanted devices. 634
However, the involved pediatric electrophysiologist does 635
not necessarily have to perform all such device 636
implantations 637
2) Track 2: Training Completed Before July 1, 2005 638
(i) Pediatric EP applicants completing training prior to July 1, 639
2005 may qualify either by satisfying Track 1 requirements 640
above, or by demonstrating a minimum level of practice 641
experience consisting of at least 5 years of active pediatric 642
electrophysiology experience, in which the applicant’s 643
primary clinical interest is pediatric electrophysiology. The 644
candidate must be actively involved in the management and 645
care of pediatric arrhythmia patients. 646
(ii) Past Experience: 647
(a) A minimum 5 year history of practicing pediatric 648
electrophysiology as his or her primary clinical interest. 649
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(b) In that 5 year span, performance of a minimum of 150 650
EP studies of which at least 90 or 60% of the total must 651
have been catheter ablation procedures. 652
ACCF/AHA/AAP Recommendations for Training in 653
Pediatric Cardiology. A Report of the American College 654
of Cardiology Foundation/American Heart 655
Association/American Committee to Develop Training 656
Recommendations for Pediatric Cardiology) College of 657
Physicians Task Force on Clinical Competence 658
Circulation. 2005;112:2555-2580 659
(c) In addition, the individual must monitor on a continuing 660
basis at least 30 patients with implanted devices. 661
However, the involved pediatric electrophysiologist 662
does not necessarily have to perform any or all such 663
device implantations. 664
3) Foreign Trainees: Pediatric cardiologists either trained in other 665
countries, or for any other reason not eligible for certification 666
by the Sub-Board of Pediatric Cardiology of the American 667
Board of Pediatrics may be credentialed as a AHCA physician 668
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specializing in electrophysiology by the Secretary of AHCA or 669
designee as a special situation after a review and in-depth 670
evaluation by the Pediatric Cardiac Technical Advisory Panel, 671
which recommended such credentialing. 672
ii) Consulting Physicians: In addition to the physician listed above, in 673
interventional EP cardiac catheterizations, an anesthesiologist and a 674
thoracic surgeon, each with advanced training in the cardiovascular 675
aspects of their specialty, must be immediately available within the 676
facility, or in close proximity, for consultation, assistance, emergency 677
and elective surgical procedures and peri-operative care. 678
iii) Nurse: Each laboratory must have a registered nurse, with special 679
training in cardiovascular techniques and in the care of children, as a 680
full time member of the team. This nurse must have special skills in 681
pre and post catheterization evaluation, and management. In addition, 682
this individual must have skills in and be able to coordinate patient and 683
family education and instructions pre and post procedure. 684
iv) Cardiovascular EP Technologist: Each laboratory must have a 685
cardiovascular EP technologist with special training in cardiac EP 686
laboratory techniques. 687
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v) Dedicated Trained Cardiovascular EP Recorder: 688
a) Each laboratory must have a dedicated trained cardiovascular EP 689
recorder who has no other responsibilities during such 690
procedures. 691
b) Each laboratory must have immediate access to personnel trained 692
in equipment repair and maintenance. 693
c) Although the above-required functions are well defined, it is not 694
necessary for one person to fulfill each separate job category. 695
Adequate cross training for other personnel classifications 696
permits 24-hour coverage of essential team functions. 697
d) All technologists in a cardiovascular laboratory must be certified 698
by the Cardiovascular Credentialing Institute as a Registered 699
Cardiovascular Technologist (RCVT) and licensed by the State 700
of Florida under the Clinical Laboratory law, when applicable. 701
2. Equipment: 702
i) Radiological, electronic, and computer-based systems are integral 703
components of the equipment in a catheterization laboratory. These 704
systems all require a program of rigorous maintenance and 705
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troubleshooting. In addition, a pediatric electrophysiology laboratory must 706
have: 707
a) Multi Channel EP recording system 708
b) External Defibrillation system 709
c) Cardiopulmonary monitoring system 710
d) Radiofrequency Energy Source 711
e) It is strongly recommended that Pediatric Electrophysiology 712
laboratories also have: 713
1) 3 Dimensional Mapping System 714
2) Cryo ablation System 715
ii) Electrical Safety and Radiation Protection: Electrical safety and radiation 716
protection shall be followed in accordance with the manufacturer’s 717
recommendations and applicable State and Federal regulations. 718
3. Records 719
i) Permanent record of real time study must include, at a minimum, video, 720
disk, chart, or digital / electronic recordings. 721
ii) Interpretation and final approval of such EP study reports must be 722
performed by a physician who is board certified in pediatric cardiology 723
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and meets the standards to be qualified as a pediatric electrophysiologist, 724
as defined previously. 725
iii) Medical records must be retained for a period of no less than seven (7) 726
years in a secure locked area. 727
4. Initial Evaluation 728
i) Program Evaluation and Development Review: When a request is 729
received for participation as a AHCA Pediatric Cardiac Electrophysiology 730
Laboratory facility, along with attestation of compliance with all these 731
standards, a program evaluation and development review by members or 732
designees of the Pediatric Cardiac Technical Advisory Panel will be 733
scheduled as the final component of the application process. An 734
application shall not be deemed complete until the Secretary of AHCA or 735
designee receives the recommendation of the Pediatric Cardiac Technical 736
Advisory Panel. 737
ii) Medical Records Review: 738
a) A minimum of 12 consecutive pediatric cardiac catheterization 739
electrophysiologic studies within a year must be available to warrant 740
initial inspection of any facility. 741
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b) A minimum of 7 consecutive pediatric implantable device insertions 742
(pacemakers and / or Implantable Cardioverter Defibrillators) studies 743
within a year must be available to warrant initial inspection of any 744
facility. 745
iii) Facility Volume Standards: Facilities shall be evaluated independently for 746
two separate areas of expertise within a pediatric electrophysiology 747
program: EP studies with ablations and device insertions. 748
a) EP studies and ablation: The minimum annual number of pediatric 749
electrophysiologic studies in an applicant facility is recommended to 750
be at least 30 per facility with a minimum of 18 ablations, or 60% of 751
the total number of studies per year. 752
Source: PACES SURVEY, 2012 753
b) Device implantations: Pacemaker and / or Implantable - Cardioverter 754
Defibrillators (ICD) insertions. The minimum number of device 755
implantations (pacemakers and /or ICD’s) in an applicant facility is 756
recommended to be at least 10 per year. For the purpose of facility 757
volume standards, device insertions may be performed by either a 758
credentialed AHCA pediatric cardiovascular surgeon and /or a 759
credentialed AHCA pediatric electrophysiologist. 760
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iv) Practitioner Volume Standards: 761
a) Pediatric electrophysiologists shall be evaluated independently for two 762
separate areas of expertise within a pediatric electrophysiology 763
program: EP Studies with Ablations and Device Insertions 764
b) A practitioner may choose to be credentialed to perform EP Studies / 765
Ablations and Device insertions, or both. 766
1) The minimum annual number of pediatric cardiac 767
electrophysiologic studies performed by each practitioner in an 768
applicant facility is recommended to be at least 30 per year, of 769
which at least 18, or 60% of the total number of studies per year, 770
are catheter ablation procedures. 771
2) The minimum annual number of pediatric device implants 772
(pacemaker and/ or ICD) performed by each practitioner in an 773
applicant facility is recommended to be at least 10 per year. 774
Electrophysiology Society Clinical Competency Statement: 775
Training pathways for implantation of cardioverter-defibrillators 776
and cardiac resynchronization therapy devices in pediatric and 777
congenital heart patients. Developed in collaboration with the 778
American College of Cardiology and the American Heart 779
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Association. J. Philip Saul, MD, FHRS, Victoria L. Vetter, MD, 780
Heart Rhythm, Vol 5, No 6, June 2008 781
(i) Practitioners whose volume falls below 10 per year must then 782
demonstrate that they have an established working relationship 783
with either a credentialed AHCA pediatric cardiovascular 784
surgeon or a credentialed AHCA pediatric electrophysiologist 785
performing device implants or an adult electrophysiologist 786
trained in device implantation, and demonstrate that such 787
physicians are available in case they are needed. 788
v) Outcomes Standards: 789
The members of the AHCA PCTAP Cardiac Technical Advisory Panel’s 790
EP Task Force will develop and recommend that all CMS Cardiac Centers 791
participate in a database into which the involved EP physicians would 792
report the outcomes of their EP Studies and device insertions. Such 793
database recommendations will be submitted to the AHCA PCTAP 794
Cardiac Technical Advisory Panel and implemented if the Panel supports 795
such recommendations. 796
a) Outcomes Standards- Initial Phase 797
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1) Initially, AHCA Pediatric Electrophysiology programs will be 798
evaluated utilizing existing outcome expectations based on current 799
literature, with the understanding that more data needs to be 800
generated which incorporates modern technologies and 801
expectations. 802
2) The presently appointed Florida AHCA EP Task Force will create a 803
pilot data-tracking tool, which will serve as a preliminary data 804
repository. This will be implemented after a recommendation by 805
the AHCA Cardiac Technical Advisory Panel to, and approval by, 806
the Secretary of AHCA or his/her designee. 807
(i) Supraventricular Tachycardia (SVT) or Ventricular Tachycardia 808
(VT) ablation outcomes in post-surgical or abnormal anatomy 809
substrate. Acceptable success and complication standards are 810
not yet defined. However, each will be reported for ongoing 811
analysis 812
(ii) Endocardial Device Insertion Procedures. Acceptable success 813
and complication rates are not yet defined in the pediatric 814
population. However, outcomes will be reported for ongoing 815
analysis. 816
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(iii)Epicardial Device Insertion procedures are considered cardiac 817
surgeries and outcomes evaluated in the context of the involved 818
cardiovascular surgical program. 819
b) Outcomes Standards- Second Phase: 820
1) When a proposed national database (MAP-IT) is implemented and 821
incorporated into the existing national cardiac catheterization 822
database (IMPACT), the existing AHCA EP data tracking tool is 823
strongly recommended to be incorporated into this national 824
database. All AHCA pediatric cardiovascular centers are strongly 825
recommended to participate and report their data to the MAP-IT 826
national database when implemented. 827
2) When national outcome standards are defined, they will be 828
submitted to the PCTAP as the new outcome standards for Florida 829
AHCA pediatric electrophysiology centers. 830
3) Once procedural success and complication rates are measured and 831
published, the PCTAP EP Task force shall recommend that 832
acceptable program and or practitioner volume and outcomes are 833
within two standard deviations from the national mean. This 834
recommendation shall be presented to the Pediatric Cardiac 835
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Technical Advisory Panel and submitted for incorporation into the 836
present Rules by the Secretary of AHCA or his/her designee. Once 837
these new volume and outcome standards are incorporated into the 838
present Rules, programs whose volume or outcomes are below the 839
new standards shall be subject to increased surveillance and 840
potential probationary status as defined below. 841
vi) Facility Criteria: Includes all standards in the AHCA Pediatric Cardiac 842
Catheterization Laboratory Component section. 843
vii) The Secretary of AHCA or designee considers new facilities for 844
involvement in the AHCA cardiac program upon the recommendation of 845
the Pediatric Cardiac Technical Advisory Panel after meeting all the 846
criteria established above for such pediatric cardiac catheterizations. The 847
Secretary of AHCA or designee shall make the final decision on whether 848
to approve an applicant to be a Center. 849
5. Re-evaluation of AHCA Centers: 850
a) Program Evaluation and Development Review: Each AHCA Pediatric Cardiac 851
Electrophysiology Laboratory Facility must be evaluated on-site by members 852
or designees of the Pediatric Cardiac Technical Advisory Panel at a minimum 853
of once every three (3) years. The re-evaluation process is not complete until 854
Deleted: S855
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the Secretary of AHCA or designee receives the recommendations of the 856
Pediatric Cardiac Technical Advisory Panel. 857
b) Medical Record Review: A minimum of 12 consecutive pediatric cardiac 858
electrophysiologic studies must be available within a specified time period for 859
review at the time of the re-evaluation. Volume Standards are as follows: 860
c) Facility Volume Standards: The minimum annual number of pediatric 861
electrophysiologic studies in an applicant facility is recommended to be at 862
least 30 per facility with a minimum of 18 ablations, or 60% of the total 863
number of studies per year. 864
d) Practitioner Volume Standards: 865
(i) By the first or subsequent three-year review, the minimum annual number 866
of pediatric cardiac electrophysiologic studies performed by each 867
practitioner in an applicant facility is recommended to be at least 30 per 868
year, of which at least 18, or 60% of the total number of studies per year 869
are catheter ablation procedures. 870
(ii) Pediatric electrophysiologists performing device implantations are 871
recommended to perform at least 10 device implantation procedures per 872
year. 873
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e) During the initial phase of the development of outcomes standards, defined in 874
Section III.A.4.v)a), EP facilities will be evaluated by examining their 875
completeness of data submission. During this initial phase, the primary 876
evaluative assessment will be procedural outcomes as deemed acceptable 877
based on existing literature. 878
f) The second phase of outcomes evaluation, Section III.A.4.v)b), will be 879
completed once national standards are derived from national databases into 880
which all Florida EP programs are expected to submit their data. National 881
volume and outcome standards, once created, will be recommended by the EP 882
Task force to the Pediatric Cardiac Technical Advisory Panel and submitted 883
for approval by the Secretary of AHCA or designee. Once approved, then 884
these will become the volume and outcome standards by which each program 885
is to be evaluated. 886
g) If the site review team determines the facility meets acceptable standards and 887
has acceptable outcomes, then the facility and practitioner will be subject to 888
be a component of the three year review cycle of AHCA Pediatric 889
Cardiovascular Centers. 890
h) If the facility is below acceptable standards and with less than acceptable 891
outcomes, then the facility will be reviewed by the Pediatric Cardiac 892
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Technical Advisory Panel which may recommend that the facility be placed 893
on probationary status for one year. Probationary status may be extended one 894
(1) additional year if the facility documents a positive trend in meeting the 895
outcomes standard. If the facility has not achieved the acceptable outcomes 896
standard at the end of a second year of probationary status, the facility shall be 897
provided with a notice of intent to end the agreement between the AHCA 898
Pediatric Cardiovascular Center and the Agency. After a 90 day transition 899
period, the facility will receive a formal notice to end the agreement between 900
the AHCA Pediatric Cardiovascular Center and the Agency. 901
B. Outpatient Clinic Component 902
1. Facility Criteria: include all standards, as outlined in the outpatient clinic 903
section. In addition, an outpatient electrophysiology program must have 904
the following components: 905
i) Personnel: 906
a) The physician in charge of this clinic is to be board certified in 907
Pediatric Cardiology and Basic Life Support and have special 908
expertise in arrhythmias and device management 909
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b) The involved nurse/technician is to have special expertise in device 910
management and be certified in both Basic Life Support and 911
Pediatric Advanced Life Support. 912
ii) Device Management: Pacemaker, Implantable Cardioverter 913
Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT ) 914
device monitoring is performed by combining both in-clinic and 915
remote (home) monitoring. Criteria for intervals for device follow-up 916
must recognize that the complexity of the underlying heart disease 917
dictates the intervals for such surveillance. A reasonable guide for in-918
clinic monitoring is as follows: 919
a) Antibradycardia devices: At a minimum, the patient will be seen in 920
the clinic one week and then 3 months post implant. Then the 921
patient should be seen no less frequently than annually as long as 922
clinic visits are supplemented by remote monitoring from home no 923
less frequently than every three months, and more frequently as 924
may be clinically indicated. Complexity of the issues managed or 925
device related issues may require a more intensive and frequent 926
monitoring schedule. Evaluation of surgical site may be performed 927
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by physicians in the patient’s local community when deemed 928
appropriate. 929
b) ICD and CRT devices: At a minimum, the patient will be seen in 930
the clinic within one week and then 3 months post implant. Then 931
the patient should be seen no less frequently than bi-annually as 932
long as clinic visits are supplemented by remote monitoring from 933
home no less frequently than every three months, and more 934
frequently as may be clinically indicated. Complexity of the issues 935
managed; or device related issues, may require a more intensive 936
and frequent monitoring schedule. Evaluation of surgical site may 937
be performed by physicians in the patient’s local community when 938
deemed appropriate. 939
2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for 940
Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report 941
of the American College of Cardiology Foundation/American 942
Heart Association Task Force on Practice Guidelines Cynthia M. 943
Tracy, MD et al. J Am Coll Cardiol. 2012;60(14):1297-1313. 944
iii) Equipment 945
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a) For in-clinic monitoring – the following items must be available: 946
Electrocardiographic (EKG) recording machine, External 947
Defibrillator, Device programmers for: Pacemakers, Implantable-948
Cardioverter Defibrillators (ICD’s) and Cardiac Resynchronization 949
Therapy (CRT’s). 950
b) For remote monitoring, some form of surveillance must be 951
available including traditional trans-telephonic monitoring (TTM). 952
iv) Volume: It is recommended that the involved EP physicians should 953
have managed, in their professional career, at least 75 patients with 954
devices and maintained competence by performing 30 assessments 955
annually. 956
v) Records: A complete database of patients with devices should be 957
maintained and to include all device models and ID numbers, Lead 958
models and ID numbers. 959
a) A permanent record of real time study of serial device testing must 960
be maintained and kept for at least 7 years. 961
vi) Arrhythmia Management 962
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a) Pediatric Electrophysiology clinics must be staffed by a pediatric 963
electrophysiologist and at least one skilled nurse. Visit frequency is 964
dictated individually by the severity of the arrhythmia. 965
1) Visits are recommended to include: 966
(i) Antiarrhythmic drug management, verification of drug 967
dosages and drug- drug interactions 968
(ii) Surveillance of arrhythmia monitoring tests which may 969
include a 12 lead electrocardiogram, Holter monitor 970
electrocardiography, event or memory loping monitors, and 971
a stress test. 972
(iii)Cardiac channelopathy patients are monitored as frequently 973
as the specific disease requires. Proper management of 974
these syndromes is recommended to include genetic testing 975
of the proband followed by family specific testing, and 976
genotype specific drug management and counseling. 977
vii) Evaluation of Participating Facilities: 978
1) If the facility is not in compliance with all the required personnel 979
and equipment criteria as described previously, the facility must 980
submit a corrective action plan for approval by the Secretary of 981
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AHCA or designee upon the recommendation of the Pediatric 982
Cardiac Technical Advisory Panel. If the plan is approved, the 983
facility shall be granted a one-year probationary status. 984
Probationary status may be extended one (1) additional year if the 985
facility documents improvements toward achieving all the facility 986
criteria. If the facility is not in compliance with all the facility 987
criteria at the end of a second year of probationary status, the 988
facility shall be provided with a notice of intent to end the 989
agreement between the AHCA Pediatric Cardiovascular Center and 990
the Agency. After a 90 day transition period, the facility will 991
receive a formal notice to end the agreement between the AHCA 992
Pediatric Cardiovascular Center and the Agency. 993
2) Data Submission: The staff of all AHCA Pediatric Cardiac 994
Electrophysiology Centers must collect and submit quality 995
assurance data annually in accordance with the following AHCA 996
forms: 997
(i) Cardiac Catheterization Procedures (DH-CMS 2057, 998
10/20XX); 999
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(ii) Cardiac Catheterization Cases--Primary Cardiac Diagnoses 1000
(DH-CMS 2058, 10/20XX); and 1001
(iii)Pediatric Cardiac Electrophysiology Laboratories (DH-CMS 1002
XXXX, XX/XX). 1003
The Secretary of AHCA or designee considers existing facilities for continuing 1004
involvement based upon the recommendation of the Pediatric Cardiac Technical 1005
Advisory Panel and all the criteria established above. The Secretary of AHCA or 1006
designee shall make the final decision as to whether or not to continue such an agreement 1007
with the Agency. 1008
IV. Standards for AHCA Pediatric Cardiovascular Surgery Program Component 1009
A. Diagnosis and treatment are so closely related that an AHCA Pediatric 1010
Cardiovascular Surgery Program, AHCA Pediatric Cardiac Catheterization 1011
Laboratory Component and an AHCA Pediatric Cardiology Clinic Component 1012
must be co-located on the same campus. 1013
B. General pediatric coverage with sub-specialty capability twenty-four hours a 1014
day, seven days a week. 1015
C. An effective system (with documentation) of rapid referral and transportation. 1016
D. Cardiac Team - Pediatric Cardiovascular Surgery Program must have 1017
accredited pediatric and general surgery training programs with house staff or 1018
Pediatric Cardiovascular Center Standards
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Deleted: August 2014
must have other arrangements to provide 24-hour physician or house staff 1019
coverage. 1020
1. An AHCA credentialed thoracic and cardiovascular surgeon with special 1021
training, interest and experience with pediatric cardiac patients and 1022
certification by the American Board of Thoracic Surgery. All such 1023
surgeons will have 5 years to become Board Certified after becoming 1024
eligible for such an examination.(? subspecialty Certificate Congenital 1025
Cardiac Surgery by the ABTS) 1026
2. AHCA credentialed associate thoracic and cardiovascular surgeon with 1027
special training interest and experience with pediatric cardiac patients and 1028
certification by the American Board of Thoracic Surgery. Such an 1029
associate surgeon should be either “on-site”, available through an 1030
established agreement with another AHCA Pediatric Cardiovascular 1031
Center, or available by an established organizational format approved by 1032
the Secretary of AHCA or designee. 1033
3. In regards to the above thoracic and cardiovascular surgeons, since the 1034
new Sub-Board of Pediatric Cardiovascular Surgery under the American 1035
Board of Thoracic Surgery is now fully implemented, each surgeon who 1036
started such training after July 1, 2008 must be certified by this new Board 1037
Commented [AH1]: Dr. Guleserian Question: (? subspecialty Certificate in Congenital Cardiac Surgery by the ABTS)
Commented [AH2]: Dr. Pigula’s Question
Pediatric Cardiovascular Center Standards
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within 5 years of becoming eligible.( and must complete maintenance of 1038
certification (MOC) as per the ABTS and subspecialty certification by the 1039
ABTS) 1040
4. Pediatric cardiovascular surgeons, either trained in other countries or for 1041
any other reason not eligible for certification by the American Board of 1042
Thoracic Surgery, or the new Sub-Board of Pediatric Cardiovascular 1043
Surgery, may be credentialed as an AHCA physician by the Secretary of 1044
AHCA or designee as a special situation after a review and in-depth 1045
evaluation by the Pediatric Cardiac Technical Advisory Panel, which 1046
recommended such approval. 1047
5. Pediatric sub-specialists with expertise in hematology, nephrology, 1048
neurology, infectious disease, critical care, genetics, gastroenterology and 1049
pulmonology must be available for consultation and management of 1050
patients with heart disease. 1051
6. Radiologist trained in cardiopulmonary disease. 1052
7. Anesthesiologist with training and experience in open and closed heart 1053
pediatric anesthesia. 1054
8. Respiratory Therapist with training and experience in short and long-term 1055
ventilatory support in infants and children. 1056
Commented [AH3]: Dr. Pigula’s Edit
Commented [AH4]: Dr. Pigula’s Edit
Pediatric Cardiovascular Center Standards
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9. Technicians available 24 hours a day for laboratory and radiology 1057
procedures. 1058
10. Perfusionist who is certified by the American Board of Cardiovascular 1059
Perfusion in the area of cardiovascular perfusion.(number to be specified?) 1060
11. Specially trained nurses for preoperative evaluation and instruction of the 1061
patient and family, intensive care, and convalescent care. 1062
12. Pathologist with skills and training in cardiovascular pathology. 1063
13. The facility must identify and utilize a core surgical team. 1064
14. Involved staff will make a priority of maintaining on-going 1065
communication throughout the patient’s hospital course with the patient’s 1066
primary care physician. 1067
15. Continuous availability of a team skilled in performing intra-operative 1068
TEE’s to aid in the post-surgical assessment of operative procedures. 1069
16. Availability of Extra Corporeal Life Support (ECLS)EMCO?? 1070
E. Pre-operative Preparation 1071
1. Dedicated pediatric patient rooms with provision for a parent, relative or 1072
guardian to remain overnight with hospitalized child. 1073
Commented [AH5]: Dr. Pigula’s Edit
Commented [AH6]: Dr. Pigula’s Question
Pediatric Cardiovascular Center Standards
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2. Clear instructions to parents and patient with pre-operative visits to 1074
catheterization laboratory, intensive care unit, and other sites as needed, 1075
consistent with their ability to comprehend. 1076
3. Care management conference between the pediatric cardiologist, pediatric 1077
cardiovascular surgeon, and other professional staff as necessary 1078
documented in the patient record. 1079
F. Post-operative Care 1080
1. All post-operative care must be under the direction of the involved AHCA 1081
credentialed cardiovascular surgeons in constant (24/7) communication with, 1082
and in support of, the post-operative cardiovascular team composed of 1083
pediatric intensivists, cardiologists, neonatologists, anesthesiologists, and 1084
other personnel as needed. In certain cases, the involved pediatric 1085
cardiovascular surgeon may transfer primary responsibilities (define) to 1086
another member of the team, such as cases with arrhythmias, or neonates on 1087
Extra Corporeal Membrane Oxygenation (ECMO) in the neonatal intensive 1088
care unit (NICU). 1089
2. Each AHCA Pediatric Cardiovascular Surgical Facility must have a 1090
dedicated Pediatric Cardiovascular Intensive Care Unit with personnel 1091
specially trained in Congenital Heart Surgery, including physicians, nurses, 1092
Commented [AH7]: Dr. Gulersrian Comment: Define
Pediatric Cardiovascular Center Standards
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respiratory specialists, and ancillary staff. Such a unit may be either a 1093
separate cardiac ICU or a dedicated component within a Pediatric Intensive 1094
Care Unit. 1095
Guidelines for Pediatric Cardiovascular Centers: Pediatrics. 2002: Vol. 109 1096
No. 3 544-549 1097
G. Initial Evaluation 1098
1. Program Evaluation and Development Review: When a request is 1099
received for involved as an AHCA pediatric cardiovascular surgery 1100
facility, along with attestation of compliance with all these standards, a 1101
program evaluation and development review by members or designees of 1102
the Pediatric Cardiac Technical Advisory Panel shall be scheduled as the 1103
final component of the application process. An application shall not be 1104
deemed complete until the Secretary of AHCA or designee for AHCA or 1105
designee receives the recommendation of the Pediatric Cardiac Technical 1106
Advisory Panel. 1107
2. Medical Records Review: A minimum of 25 consecutive pediatric cardiac 1108
surgical cases must be available within a specified time period to warrant 1109
initial program evaluation and development review of any facility. 1110
Pediatric Cardiovascular Center Standards
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Facility Volume Standard: The minimum annual (12 consecutive 1111
months) number of pediatric cardiac surgeries in a facility requesting to 1112
become an AHCA Pediatric Cardiovascular Center is 101 index cardiac 1113
operations as defined by Society of Thoracic Surgeons (STS). 1114
Additionally, each center must do 90 open heart cases in a 12 month 1115
period, i.e. on Cardiopulmonary (CB) bypass. Open heart cases are now 1116
counted by CMS criteria not STS criteria. Thus, multiple CB operations, 1117
on the same patient during the same admission count individually. (101, 1118
150, provide data to support) Surgical Volume for Pediatric and 1119
Congenital Heart Surgery: Total Programmatic Volume and 1120
Programmatic Volume Stratified by Five STS-EACTS Mortality Levels: 1121
NATIONAL QUALITY FORUM. Measure Evaluation 4.1 2009;1-21. 1122
Association of Center Volume With Mortality and Complications in 1123
Pediatric Heart Surgery: Pediatrics 2012:129; e370-e376 1124
1125
An empirically based tool for analyzing mortality associated with congenital 1126
heart surgery. The Journal of Thoracic and Cardiovascular Surgery. 2009: 1127
Vol. 138 No. 5; 1139-1153 1128
Commented [AH8]: Dr. Guleserian Comment
Commented [AH9]: Dr. Scholl’s Comment: Probably ought to consider lowering the case count volume requirement and changing this line to be in alignment with STS guidelines. Only one index case will count per admission.
Pediatric Cardiovascular Center Standards
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i) NATIONAL VOLUNTARY CONSENSUS STANDARDS FOR 1129
PEDIATRIC CARDIAC SURGERY: A CONSENSUS REPORT. 1130
National Quality Forum 2012: 1-18.For the purposes of counting 1131
cardiac surgical volume in an AHCA Pediatric Cardiovascular 1132
Center, AHCA further defines pediatric cardiac surgeries to 1133
include the following: 1134
a) Cardiac Surgery: Cardiac surgical cases performed by each 1135
facility’s pediatric cardiovascular surgeon(s), including: 1136
1) Only cardiac operations count, as defined by the STS 1137
Congenital Heart Surgery Database as CPB (Cardio 1138
Pulmonary By-Pass) or No CPB Cardiovascular; 1139
2) Cardiac surgeries performed on pediatric patients (pediatric 1140
patient is defined by the Society of Thoracic Surgeons 1141
Database as from birth to 18 years of age); 1142
3) Cardiac surgeries performed on adult patients in whom the 1143
primary cardiac surgical component is congenital; 1144
4) Non-cardiac surgeries performed on cardiopulmonary by-1145
pass by the facility’s pediatric cardiovascular surgeon(s); 1146
Deleted: heart disease1147
Commented [AH10]: Dr. Guleserian Edit
Pediatric Cardiovascular Center Standards
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5) Surgical closure of a patent ductus arteriosus, including all 1148
premature infants, regardless of age; 1149
6) Placement of a cardiac pace-maker or defibrillator, in 1150
which the facility’s pediatric cardiovascular surgeon(s) is 1151
the implanting physician/surgeon; and 1152
7) Hybrid cardiac cases involving a surgical component. 1153
8) Heart transplantation and ventricular assist device 1154
placement in pediatric patients. 1155
b) Additionally, the following procedures are NOT considered 1156
when determining cardiac surgical volume: 1157
1) Cardiac surgeries not performed by the facility’s pediatric 1158
cardiovascular surgeon(s); 1159
2) Delayed sternal closure; 1160
3) Re-exploration of the mediastinum; for example, excessive 1161
bleeding; 1162
4) Operations where ECMO cannulation or decannulation is 1163
the primary procedure and any operations classified by the 1164
STS Congenital Heart Surgery Database as Operation Type 1165
= ECMO; and 1166
Deleted: primary physician of record1167
Commented [AH11]: Dr. Guleserian Edit
Commented [AH12]: Dr. Scholl’s Edit
Pediatric Cardiovascular Center Standards
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5) Any operation classified by the STS Congenital Heart 1168
Surgery Database as an Operation Type other than CPB 1169
(CPB = Cardio Pulmonary = By-Pass) or No CPB 1170
Cardiovascular. 1171
ii) To further clarify surgical volume for the purposes of AHCA 1172
volume requirements, surgical volume should be calculated based 1173
on each cardiac surgical admission that involves a cardiac surgical 1174
operation. For example, if patient A comes to the facility and has a 1175
cardiac operation and then has a second cardiac operation later but 1176
during the same admission, that would be counted as one surgery. 1177
FPAs another example, if patient B has multiple component 1178
procedures performed during the same cardiac operation, that 1179
would also be counted as one operation. Such guidelines are 1180
identical to the rules used by The Society of Thoracic Surgeons 1181
Database to calculate programmatic volume using index cardiac 1182
operations. AHCA utilizes such national standards whenever 1183
available (including social admissions? Disposition displacement 1184
due to hurricane, for example?). 1185
Commented [AH13]: Dr. Scholl’s Comment: This seems to contradict volume calculations as noted in line 1124, 1125. See above the comment on line 1129
Commented [AH14]: Dr. Scholl’s Edit
Deleted: As1186
Commented [AH15]: Dr. Guleserian Question
Pediatric Cardiovascular Center Standards
September 2018
65
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Deleted: August 2014
3. The facility must be co-located with an AHCA Pediatric Cardiology Clinic 1187
Facility and an AHCA Pediatric Catheterization facility. 1188
4. Facility Criteria: include all standards in the AHCA Pediatric 1189
Cardiovascular Surgery Program Component section. If the facility is not 1190
in compliance with all the required criteria other than the volume 1191
standards, the facility must submit a corrective action plan for approval by 1192
the Secretary of AHCA or designee upon the recommendation of the 1193
Pediatric Cardiac Technical Advisory Panel. If the plan is approved, the 1194
facility shall be granted a one (1) year probationary status. Probationary 1195
status may be extended one (1) additional year if the facility documents 1196
improvements toward achieving all the facility criteria. If the facility is 1197
not in compliance with all the facility criteria at the end of a second year 1198
of probationary status, the facility shall be provided with a notice of intent 1199
to end the agreement between the AHCA Pediatric Cardiovascular Center 1200
and the Agency. 1201
5. The Secretary of AHCA or designee considers new facilities for 1202
involvement upon the recommendation of the Pediatric Cardiac Technical 1203
Advisory Panel and after fulfilling all criteria established above for 1204
pediatric cardiac surgery. The Secretary of AHCA or designee shall make 1205
Pediatric Cardiovascular Center Standards
September 2018
66
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Deleted: August 2014
the final decision on whether or not a facility may continue such an 1206
agreement with the Agency. 1207
H. Re-evaluation of Approved Facilities 1208
1. Program Evaluation and Development Review: Each AHCA Pediatric 1209
Cardiovascular Surgical Facility must be re-evaluated on-site by members 1210
or designees of the Pediatric Cardiac Technical Advisory Panel at a 1211
minimum of once every three (3) years. The process of re-evaluation is 1212
not complete until the Secretary of AHCA or designee receives the 1213
recommendation of the Pediatric Cardiac Technical Advisory Panel. 1214
2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 1215
surgical cases must be available within a specified time period for review 1216
at the time of the re-evaluation. 1217
3. Facility Volume Standard: By the first and all subsequent three year 1218
program evaluation and development reviews, the minimum annual 1219
number of pediatric cardiac surgeries for a AHCA Pediatric 1220
Cardiovascular Center is 101,at least 90 of which must be cases involving 1221
open heart surgery (meaning cardiopulmonary bypass procedures) 1222
Commented [AH16]: Dr. Scholl’s Comment: Who visits, What is the structure of such visits? Feedback, reports? To whom?? FP Would recommend we continue site visits and change language here to be a bit more specific, using similar format as was done in the past.
Commented [AH17]: Dr. Scholl’s Edit: Should this be an averaged volume of 101/90 over the three period time period ???? Needs discussion given the issues raised further up around 1129, etc. This should be discussed on call
Commented [AH18]: Dr. Guleserian Comment
Pediatric Cardiovascular Center Standards
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i) For the purposes of counting cardiac surgical volume in an AHCA 1223
Pediatric Cardiovascular Center, AHCA further defines pediatric 1224
cardiac surgeries to include the following: 1225
a) Cardiac Surgery: Cardiac surgical cases performed by each 1226
facility’s pediatric cardiovascular surgeon(s), including: 1227
1) Only cardiac operations count, as defined by the STS 1228
Congenital Heart Surgery Database as CPB (Cardio 1229
Pulmonary By-pass) or No CPB Cardiovascular; 1230
2) Cardiac surgeries performed on pediatric patients (pediatric 1231
patient is defined by the Society of Thoracic Surgeons 1232
Database as from birth to 18 years of age); 1233
3) Cardiac surgeries performed on adult patients in whom the 1234
primary cardiac component is congenital; 1235
4) Non-cardiac surgeries performed on cardiopulmonary by-1236
pass by the facility’s pediatric cardiovascular surgeon(s); 1237
5) Surgical closure of a patent ductus arteriosus, including all 1238
premature infants, regardless of age; 1239
Deleted: P1240
Commented [AH19]: Dr. Guleserian Edit
Deleted: heart disease 1241
Commented [AH20]: Dr. Guleserian Edit
Pediatric Cardiovascular Center Standards
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Deleted: August 2014
6) Placement of a cardiac pace-maker or defibrillator, in 1242
which the facility’s pediatric cardiovascular surgeon(s) is 1243
the primary physician of record; and 1244
7) Hybrid cardiac cases involving a surgical component. 1245
8) Heart transplantation and placement ventricular assist 1246
device in pediatric patients. 1247
b) Additionally, the following procedures are NOT considered 1248
when determining cardiac surgical volume: 1249
1) Cardiac surgeries not performed by the facility’s pediatric 1250
cardiovascular surgeon(s); 1251
2) Delayed sternal closure; 1252
3) Re-exploration of the mediastinum; for example, excessive 1253
bleeding; 1254
4) Operations where ECMO cannulation or decannulation is 1255
the primary procedure and any operations classified by the 1256
STS Congenital Heart Surgery Database as Operation Type 1257
= ECMO; and 1258
5) Any operation classified by the STS Congenital Heart 1259
Surgery Database as an Operation Type other than CPB 1260
Commented [AH21]: Dr. Scholl’s Edit
Pediatric Cardiovascular Center Standards
September 2018
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Deleted: Children’s Medical Services
Deleted: August 2014
(CPB = Cardio-pulmonary = Bypass) or No CPB 1261
Cardiovascular. 1262
ii) To further clarify surgical volume for the purposes of AHCA 1263
volume requirements, surgical volume should be calculated based 1264
on each cardiac surgical admission that involves a cardiac surgical 1265
operation. For example, if patient A comes to the facility and has a 1266
cardiac operation and then has a second cardiac operation later but 1267
during the same admission, that would be counted as one surgery. 1268
As another example, if patient B has multiple component 1269
procedures performed during the same cardiac operation, that 1270
would also be counted as one operation. Such guidelines are 1271
identical to the rules used by The Society of Thoracic Surgeons 1272
Database to calculate programmatic volume using index cardiac 1273
operations. AHCA utilizes such national standards whenever 1274
available. 1275
i. 1276
4. If the facility volume is below (101? 150?) , the facility shall be placed on 1277
probationary status for one (1) year. Probationary status may be extended 1278
one (1) additional year if the facility documents a positive trend in meeting 1279
Deleted: 1280
Deleted: P1281
Deleted: By-Pass1282
Commented [AH22]: Dr. Guleserian Edit
Deleted: 1501283
Commented [AH23]: Dr. Guleserian Edit
Pediatric Cardiovascular Center Standards
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Deleted: Children’s Medical Services
Deleted: August 2014
the volume standard. If the facility has not achieved the volume standard 1284
at the end of a second year of probationary status, the facility shall be 1285
provided with a notice of intent to end the agreement between the AHCA 1286
Pediatric Cardiovascular Center and the Agency. After a 90 day transition 1287
period, the facility will receive a formal notice to end the agreement 1288
between the AHCA Pediatric Cardiovascular Center and the Agency. 1289
5. Facility Criteria: include all standards, other than facility volume 1290
standards, in the AHCA Pediatric Cardiovascular Surgery Program 1291
Component section. 1292
If the facility is not in compliance with all the required criteria other than 1293
the volume standards, the facility must submit a corrective action plan for 1294
approval by the Secretary of AHCA or designee upon the recommendation 1295
of the Pediatric Cardiac Technical Advisory Panel. If the plan is 1296
approved, the facility shall be granted one-year probationary status. 1297
Probationary status may be extended one (1) additional year if the facility 1298
documents improvements toward achieving all the facility criteria. If the 1299
facility is not in compliance with all the facility criteria at the end of a 1300
second year of probationary status, the facility shall be provided with a 1301
notice of intent to end the agreement between that AHCA Pediatric 1302
Pediatric Cardiovascular Center Standards
September 2018
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Deleted: Children’s Medical Services
Deleted: August 2014
Cardiovascular Center and the Agency as an AHCA Pediatric 1303
Cardiovascular Center. After a 90 day transition period, the facility will 1304
receive a formal notice to end the agreement between that AHCA 1305
Pediatric Cardiovascular Center and the Agency. 1306
6. All AHCA Pediatric Cardiovascular Centers must collect and submit the 1307
following quality assurance data to STS: 1308
Number of patients/ operations submitted and an analysis, discharge 1309
mortality, and complexity information, by year 1310
Aristotle Basic Complexity Level Discharge Mortality, by year 1311
RACHS-1 Discharge Mortality, by year 1312
Number of patients/operations in analysis, discharge mortality, and 1313
complexity information, by age group 1314
Aristotle Basic Complexity Level Discharge Mortality, by age group 1315
RACHS-1 Discharge Mortality, by age group 1316
Primary procedure outcomes, by anomaly 1317
STS-EACTS Mortality Category Discharge Mortality, by year 1318
STS-EACTS Mortality Category Discharge Mortality, by age group 1319
1320
Pediatric Cardiovascular Center Standards
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Deleted: August 2014
7. Collect and submit quality assurance data annually in accordance with 1321
following CMS form: 1322
Patients with Fetal Diagnosis of Heart Conditions (DH-CMS 2065, 1323
10/20XX) 1324
1325
8. In the event that a facility’s participation with AHCA is terminated by 1326
either the facility or AHCA, a 90 day notice shall be provided to that AHCA 1327
Pediatric Cardiovascular Center. 1328
9. The Secretary of AHCA or designee considers existing facilities for 1329
continued involvement upon the recommendation of the Pediatric Cardiac 1330
Technical Advisory Panel and fulfillment of all the criteria established above. 1331
The Secretary of AHCA or designee shall make the final decision as to 1332
whether or not to continue such an agreement with the Agency. 1333
1334