agency for health care administration pediatric ......pediatric cardiovascular center standards...

Pediatric Cardiovascular Center Standards

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Deleted: Children’s Medical Services

Deleted: August 2014

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Agency for Health Care Administration 3

Pediatric Cardiovascular Center Standards 4

September 2018 5

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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

13

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

28

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

36

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

62

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

87

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

98

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

102

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

171

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


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


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


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


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





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


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


September 2018

32



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


September 2018

34



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


September 2018

35



(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


September 2018

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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


September 2018

37



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


September 2018

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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


September 2018

39



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


September 2018

40



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


September 2018

41



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


September 2018

42



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


September 2018

43



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


September 2018

44



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


September 2018

45



(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


September 2018

46



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


September 2018

47



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


September 2018

49



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


September 2018

50



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


September 2018

51



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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52



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


September 2018

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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


September 2018

56



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


September 2018

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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



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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 [AH6]: Dr. Pigula’s Question


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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


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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


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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.


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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


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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 [AH12]: Dr. Scholl’s Edit


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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


Deleted: As1186

Commented [AH15]: Dr. Guleserian Question


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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


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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


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


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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


Deleted: heart disease 1241



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68



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



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69



(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


Deleted: 1501283



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70



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





notice of intent to end the agreement between that AHCA Pediatric 1302


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71



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


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72



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


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

agency for health care administration pediatric ......pediatric cardiovascular center standards...

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