pediatric cardiovascular center standards

Children’s Medical Services Pediatric Cardiovascular Center Standards

August 2014

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Children’s Medical Services 3

Pediatric Cardiovascular Center Standards 4

August 2014 5

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Children’s Medical Services (CMS) Pediatric Cardiovascular Centers undergo a quality 8

assurance process that ensures such CMS Pediatric Cardiovascular Centers meet 9

established minimum standards deemed necessary for the provision of quality cardiac 10

services to children with special health care needs. CMS encourages the creation of 11

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 the Department of Health as a CMS Pediatric Cardiovascular Center. A CMS 15

Pediatric Cardiovascular Center will consist of the 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 20

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A CMS Pediatric Cardiovascular Center must provide care for all CMS enrolled 22

individuals with congenital and acquired heart disease who require such expertise. For 23

volume standard purposes, “pediatric cardiac” cases include children with congenital and 24

acquired heart disease under age 21 years and adults 21 years or older with congenital 25

heart disease. 26

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For the purposes of CMS Pediatric Cardiovascular Center program evaluation, 28

development and review, each distinct facility component will be surveyed individually 29

within a multi-site Pediatric Cardiovascular Center. Each of its individual components 30

must meet or exceed CMS standards; that is, each hospital-based team must perform the 31

minimum number of echocardiograms, catheterizations, electrophysiologic studies and 32

surgeries specified herein. Each component in the CMS Pediatric Cardiovascular Center 33

shall be evaluated based on its own merits. 34

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All CMS Pediatric Cardiovascular Centers must: 36


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1. Be located within a healthcare facility that maintains accreditation by the Joint 37

Commission on Accreditation of Healthcare Organizations (JCAHO) and/or the 38

National Committee for Quality Assurance (NCQA). 39

2. Be HIPAA (Health Insurance Portability and Accountability Act) compliant. 40

3. Provide limited English proficiency services, in accordance with Federal 41

guidelines. 42

4. Have quality assurance and quality improvement processes in place that 43

continuously enhance the clinical operation and patient satisfaction with services. 44

5. Collect and submit quality assurance data annually in accordance with the 45

following CMS forms: 46

Pediatric Cardiology Clinic Laboratory Procedures (DH-CMS 2056, 47

10/20XX) 48

Pediatric Cardiac Catheterization Procedures (DH-CMS 2057, 10/20XX) 49

Cardiac Catheterization Cases--Primary Cardiac Diagnoses (DH-CMS 2058, 50

10/20XX). 51

Patients with Fetal Diagnosis of Heart Conditions (DH-CMS 2065, 10/20XX) 52

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The above forms are hereby adopted and incorporated by reference. All forms 54

adopted and incorporated by reference in these standards are available upon 55


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request from Children’s Medical Services, Department of Health, 4052 Bald 56

Cypress Way, Bin # A-06, Tallahassee, Florida 32399-1707. 57

6. Actively participate in the Society of Thoracic Surgeons (STS) Congenital Heart 58

Surgery Database. 59

7. Participate in the STS Congenital Heart Surgery Database Anesthesia Module. 60

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8. Participate in the Improving Pediatric and Adult Congenital Treatments 62

(IMPACT) database. 63

9. Collect and submit the following quality assurance data annually, from their 64

annual STS Congenital Heart Surgery Database Report: 65

Number of patients/operations submitted and an analysis of discharge 66

mortality, and complexity information, by year 67

Aristotle Basic Complexity Level Discharge Mortality, by year 68

Risk-Adjusted Congenital Heart Surgery (RACHS)-1 Discharge Mortality, by 69

year 70

Number of patient/operations in analysis, discharge mortality, and complexity 71

information, by age group 72

Aristotle Basic complexity Level Discharge Mortality, by age group 73

RACHS-1 Discharge Mortality, by age group 74


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Primary Procedure Discharge Mortality based on Aristotle Basic Complexity 75

Score, sorted by anomaly 76

STS-EACTS (European Association of Cardio-Thoracic Surgery) Mortality 77

Category Discharge Mortality, by year 78

STS-EACTS Mortality Category Discharge Mortality, by age group 79

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All CMS Pediatric Cardiovascular Centers must implement electronic medical record 81

technology. 82

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All CMS Pediatric Cardiovascular Centers with birthing centers must have a neonatal 84

screening program using pulse oximetry to detect critical congenital heart disease. 85

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A multidisciplinary cardiac team must include pediatric cardiology, cardiovascular 87

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

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

and post-operative care and follow-up. 90

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All physicians and other licensed healthcare professionals that require credentialing 92

through the CMS credentialing process and are providing care at a CMS Pediatric 93


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Cardiovascular Center must be CMS credentialed providers, as specified in rule 64C-94

4.001 Florida Administrative Code (F.A.C.). 95

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Facilities requesting to be involved as a CMS Pediatric Cardiovascular Center must 97

submit a formal request to the Deputy State Health Officer for CMS or designee at 4052 98

Bald Cypress Way, Bin # A-06, Tallahassee, Florida, 32399-1707. 99

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I. Standards for CMS Hospital Co-located Pediatric Cardiology Clinic 101

A. The hospital pediatric cardiology clinic must be co-located with a CMS 102

Pediatric Cardiac Catheterization Laboratory. 103

B. All echocardiography laboratories performing Transthoracic Echoes (TTE), 104

Trans Esophageal Echoes (TEE) and Fetal Echoes (FE) must be accredited by 105

the Intersocietal Accreditation Commission (IAC) prior to their initial or 106

subsequent program evaluation and development review. 107

C. A pediatric cardiology clinic must be able to perform diagnostic evaluations 108

including, but not limited to, echocardiographic recording, Holter monitoring, 109

exercise testing, and serial pacemaker monitoring. They must either be able to 110

perform fetal echocardiograms or have access to a fetal echocardiography 111

facility. Each center must annually perform at least 50 procedures each for 112


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Holter monitor recordingsand serial pacemaker monitoring procedures. Each 113

center must annually perform at least 50 exercise testing studies. 114

D. Fetal echocardiograms performed by a physician outside the physical 115

boundaries of an IAC approved facility may be counted toward the required 116

Facility Volume Standards so long as all of the following criteria are met: 117

1. The physician performing the fetal echocardiogram is on the medical staff of 118

the hospital facility and affiliated with the hospital’s pediatric cardiology 119

program; 120

2. The physician performing the fetal echocardiogram is a CMS credentialed 121

physician; 122

3. The program provides evidence that the physician maintains appropriate 123

times of operation and protocols, including proper affiliation agreements to 124

ensure availability and appropriate referrals in the event of emergencies; and 125

4. The fetal echocardiographic laboratory is accredited by IAC. 126

E. Cardiology Clinic Components 127

1. Pediatric Cardiology Clinic: 128

i) Physicians – The physician in charge of a Pediatric Cardiology Clinic 129

must be board-certified by the Sub-board of Pediatric Cardiology of 130

the American Board of Pediatrics. Recertification or maintenance of 131


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competency (MOC) certificates of such a physician will be an integral 132

component of all future CMS program evaluation and development 133

reviews. Board eligibility as an equivalent for board certification will 134

not be considered as a criterion for credentialing beyond 5 years of 135

eligibility unless a specific exception is made by the Deputy State 136

Health Officer for CMS or designee. 137

ii) Nurse - A registered nurse who has expertise with cardiac problems in 138

children must participate in each cardiac clinic. 139

iii) Social Worker or another individual capable of performing social 140

service functions. 141

2. Echocardiography Laboratory: 142

i) A physician who is board certified in pediatric cardiology. 143

ii) A sonographer who is a Registered Diagnostic Cardiac Sonographer 144

(RDCS), American Registry of Diagnostic Medical Sonographers 145

(ARMDS), or Registered Cardiovascular Technologist (RCVT) 146

pediatric certified. 147

iii) The echocardiography laboratory workstation must include a study 148

review area with dictation capabilities, and supplies and equipment 149

necessary for compilation and analysis of echocardiographic studies. 150


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3. Holter Monitoring Laboratory: 151

A physician who is board certified in pediatric cardiology. 152

4. Exercise Treadmill Laboratory: 153

i) A physician who is board certified in pediatric cardiology. 154

ii) A Basic Life Support (BLS) certified cardiology technologist or 155

respiratory care practitioner. 156

iii) Pediatric Advanced Life Support (PALS) trained personnel available 157

in-house. 158

iv) The exercise treadmill lab must include a remote “code” button and 159

telephone. 160

v) Each center should have access to a metabolic exercise laboratory, in 161

which oxygen utilization and the anaerobic threshold can be 162

determined, as an adjunct to detecting early failing cardiopulmonary 163

function. 164

vi) All CMS institutions should follow the guidelines set forth in the 165

American Heart Association Scientific Statement on "Clinical Stress 166

Testing in the Pediatric Age Group" (Circulation. 2006; 113:1905-167

1920). 168

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vii) Specifically, CMS requires that involved institutions: 170

S 171

a) Maintain an appropriate pediatric exercise physiology 172

laboratory, including 173

1) Age- and size-appropriate treadmill and/or cycle ergometer 174

2) Age- and size-appropriate blood pressure cuffs 175

3) Age- and size-appropriate oxygen saturation monitor 176

4) EKG recording equipment 177

5) An emergency resuscitation cart that includes emergency 178

drugs, a defibrillator, supplemental oxygen, and a portable 179

suction unit 180

6) A log demonstrating periodic testing of the defibrillator and 181

oxygen supply, and periodic inspection of emergency drug 182

expiration dates 183

b) Conduct all stress tests with at least one person trained in 184

pediatric advanced life support (PALS) in the room at all times 185

with the patient during the test 186

c) Conduct all stress tests with a physician immediately available 187

(i.e. in the building) 188


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d) Perform a minimum of 50 pediatric exercise stress tests per 189

year 190

e) Obtain meaningful written consent for the stress test (which 191

may be a hospital-wide standard consent form filled out 192

specifically for stress testing) 193

viii) PCMS institutions are recommended to: 194

a) Have oversight of the laboratory and testing procedures 195

provided by a physician trained in exercise testing and exercise 196

physiology 197

b) Be able to perform spirometry/pulmonary function testing 198

c) Be able to perform metabolic stress tests 199

d) Be able to perform or refer patients for stress echocardiography 200

e) Be able to perform or refer patients for pharmacologic stress 201

testing 202

f) Be able to perform or refer patients for nuclear myocardial 203

blood flow imaging 204

5. Serial monitoring and management of implanted electronic devices, such 205

as pacemakers and defibrillators should be an integral component of any 206

center. 207


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6. Adult Congenital Heart Clinic- Each CMS Pediatric Cardiology Clinic 208

must have a specific adult congenital heart clinic, listed by the Adult 209

Congenital Heart Association (ACHA). Such a clinic should have a 210

physician clinic director with special skills and expertise in dealing with 211

adults with congenital heart disease. 212

7. Adult Congenital Heart Programs: 213

i) All adults with congenital heart disease deserve access to 214

appropriate care. 215

ii) Each CMS Pediatric Cardiovascular Center must have as a goal to 216

provide care in alignment with national standards, utilizing as 217

guidelines those of the Adult Congenital Heart Association 218

(ACHA). 219

iii) More self-sustaining comprehensive Adult Congenital Heart 220

Programs (ACHP) will be needed to provide such type of care in 221

the future. Collaboration among CMS Pediatric Cardiovascular 222

Centers with some regionalization of expertise is encouraged. 223

iv) Existing national and international guidelines, which outline the 224

care provided in adult congenital heart programs, should be 225

utilized. 226


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v) All ACHD programs must be registered with the Adult Congenital 227

Heart Association and submit required data at established intervals. 228

vi) Personnel 229

a) The program must be directed by a physician with special skills 230

and training in caring for the adult patient with congenital heart 231

disease. 232

b) A primary goal of each ACHD program is that the Director of 233

the ACHD program be board certified by the ABP/ABIM 234

ACHD sub-board within five years of the initial examination. 235

c) Cardiac Surgeon(s) with expertise in the unique surgical 236

aspects and challenges of the adult congenital heart patient. 237

d) Social Worker who is available to the adult patient to provide 238

counseling and support services. 239

e) A health professional (ARNP or PA) whose role includes 240

coordinating care for ACHD patients. 241

f) Availability of Adult Medicine sub-specialty physicians to 242

provide consultative care. 243

g) All physicians caring for the adult congenital heart disease 244

patient be ACLS certified. 245


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h) All staff performing exercise testing on adult congenital heart 246

disease patient be ACLS certified. 247

vii) Clinic Physical Space 248

a) The clinic space used for evaluation of adult patients must be 249

in accordance with their specific needs. 250

b) Facility must be accessible to handicapped Individuals. 251

c) Availability of EKG, X-Rays, MRI studies, Echocardiography, 252

and exercise/metabolic stress testing 253

d) Availability of a conference room for multi-disciplinary 254

meetings. 255

viii) Hospital and Inpatient Facilities 256

a) The admitting facility must have expertise in the care of this 257

complex adult congenital heart patient population. 258

b) The ACHD Program must have access to a fully equipped 259

cardiac laboratory with appropriately trained personnel. 260

c) The ACHD Program must meet national standards in all 261

cardiac catheterization interventional and electrophysiology 262

procedures. 263


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d) The ACHD Program must offer a comprehensive 264

cardiovascular surgical program, with established commitment 265

from cardiac intensivists, anesthesiologists, and other adult 266

medical and surgical subspecialties. 267

ix) Patient Care Characteristics Specific to an ACHD Program – 268

Recommendations and Specific Requirements: 269

a) Patient care transition services must be emphasized during 270

patient encounters. Transition education of the pediatric 271

patient should start at age 12 years and should be documented 272

in clinic notes. Such transition programs should be coordinated 273

with the area Children’s Medical Services transition program 274

where available. 275

b) All adult patients (18 years or older) must be referred for an 276

initial evaluation by an adult congenital heart specialist. 277

c) Adult female patients with congenital heart disease must have 278

access to professional staff expert in the management of 279

contraception and pre-pregnancy counseling. In addition, 280

Genetic Counseling and Fetal Echocardiography studies must 281

be available. 282


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d) Pregnant patients with congenital heart disease must be 283

evaluated as a High-Risk Pregnancy and referred to Maternal-284

Fetal Medicine Physicians. 285

e) Health maintenance programs for adolescents and adult 286

patients with CHD should be initiated by providing each 287

patient with information related to, but not limited, to 288

recommendations on endocarditis prophylaxis, anticoagulation 289

therapy, diet, weight control, contraception, pregnancy risk and 290

exercise limitations. 291

f) There must be a major educational component that forms the 292

foundation of the ACHD program that will advance public 293

awareness, educate the medical and health care community and 294

empower those individuals with adult CHD to have 295

opportunities to be successful contributing adults to their 296

respective communities. 297

g) The ACHD program is strongly encouraged to develop 298

partnership with sister institutions to do collaborative research, 299

cultivate working relationships and form advocacy groups to 300

support their patients with CHD. These partnership building 301


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activities should aim to address the critical issues in ACHD 302

patients and aid in achieving health equity for all such adult 303

patients with congenital heart disease. 304

8. Annual updates on information submitted by each center to the ACHA 305

regarding adult congenital heart disease activities should be forwarded to 306

the CMS program staff within 30 days of such submission. 307

9. High Risk Obstetrical Cases with Fetal Cardiac Anomalies- Each CMS 308

Pediatric Cardiovascular Center must have an established protocol to 309

address the needs of such patients, usually high-risk obstetrical cases 310

having a cardiac fetal anomaly diagnosed by fetal echocardiography 311

and/or ultrasound. 312

F. Physical Facility General requirements: 313

1. The area must be suitable for performance of a high quality cardiovascular 314

examination. 315

2. Examination areas must be adequately lighted, have adjustable 316

temperature, and offer privacy to patients. 317

3. A conference room must be available for discussing cases. 318

G. Equipment - All clinic equipment must be monitored and maintained in 319

accordance with manufacturers’ recommendations. 320


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H. Radiological equipment- Access to a Radiological facility at which chest x-321

rays and other indicated radiological studies can be expeditiously performed, 322

including access to Magnetic Resonance Imaging (MRI) studies, particularly 323

to evaluate the large vessels of the chest associated with the heart. 324

I. Records 325

1. Permanent record of real time study must include, at a minimum, video, 326

disk, chart, or digital or electronic medical records. 327

2. Permanent record of real time study of Holter Monitoring studies must 328

include one or more of the following: cassette tape, disk, printed paper, 329

or digital or electronic medical records. 330

3. Permanent record of real time study of exercise treadmill testing must 331

include EKG and blood pressure recordings. 332

4. Permanent record of real time study of serial pacemaker testing must be 333

available. 334

5. Interpretation and final approval of study reports must be performed by a 335

physician who is board certified in pediatric cardiology. 336

6. Medical records must be retained for a period of no less than seven (7) 337

years in a locked area. 338


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J. Initial Evaluation 339

1. Program evaluation and development review: When a request is received 340

for involvement as a CMS Hospital co-located Pediatric Cardiology 341

Clinic, along with attestation of compliance with these standards, a 342

program evaluation and development review by members or designees of 343

the CMS Cardiac Technical Advisory Panel will be scheduled. A request 344

for involvement shall not be deemed complete until the Deputy State 345

Health Officer for CMS or designee receives the recommendation of the 346

CMS Cardiac Technical Advisory Panel. 347

2. Medical Record Review: A minimum of 25 consecutive pediatric cardiac 348

cases within a specified time period must be available to warrant initial 349

evaluation of any facility. 350

3. Facility and Practitioner Volume Standards: A facility requesting to 351

participate as a CMS Pediatric Cardiovascular Center must meet 352

requirements for and have documentation of IAC accreditation. 353

4. Facility Criteria: include all standards in the CMS Hospital co-located 354

Pediatric Cardiology Clinic Component section. 355

5. The Deputy State Health Officer for CMS or designee considers new 356

facilities for upon the recommendation of the CMS Cardiac Technical 357


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Advisory Panel and the criteria established above. The Deputy State 358

Health Officer for CMS or designee shall make the final decision on 359

whether a facility may participate by entering into an agreement with the 360

Department of Health. 361

K. Re-evaluation of CMS Pediatric Cardiovascular Centers 362

1. Program Evaluation and Development Review: Each Hospital co-located 363

Pediatric Cardiology Clinic must be re-evaluated at a minimum of once 364

every three (3) years on-site by members or designees of the CMS Cardiac 365

Technical Advisory Panel. The re-evaluation process is not complete until 366

the Deputy State Health Officer for CMS or designee receives the 367

recommendation of the CMS Cardiac Technical Advisory Panel. 368


cases within a specified time period must be available for review at the 370

time of the re-evaluation. 371

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


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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 CMS Pediatric Cardiovascular Center and 380

the Department of Health as a participating CMS Pediatric Cardiovascular 381

Center. 382

4. IAC Accreditation: By the initial or subsequent program evaluation and 383

development review, all echocardiography laboratories, TTE, TEE, and 384

FE must be accredited by the IAC, whether within the center or “off-site”. 385

5. Facility Criteria: include all standards in the CMS Hospital co-located 386

Pediatric Cardiology Clinic Component section. If all facility criteria 387

other than volume standards are not met, the facility must submit a 388

corrective action plan for approval by the Deputy State Health Officer for 389

CMS or designee, upon the recommendation of the CMS Cardiac 390

Technical Advisory Panel. If the plan is approved, the facility shall be 391

granted a one (1) year probationary status. Probationary status may be 392

extended one (1) additional year if the facility documents improvements 393

toward achieving all the facility criteria. If the facility is not in 394

compliance with all the facility criteria at the end of a second year of 395


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probationary status, the facility shall be provided with a notice of intent to 396

end the agreement between the CMS Pediatric Cardiovascular Center and 397

the Department of Health. After a 90-day transition period, the facility 398

will receive formal notice of the end of the agreement between the CMS 399

Pediatric Cardiovascular Center and the Department of Health. 400

6. Data Submission: All CMS Pediatric Cardiology Clinics must collect and 401

submit quality assurance data annually in accordance with the following 402

CMS form: 403

Pediatric Cardiology Clinic Laboratory Procedures (DH-CMS 2056, 404

10/20XX) 405

7. In the event that a facility’s participation with CMS is terminated by either 406

the facility or CMS, a 90 day notice shall be provided to the CMS 407

Pediatric Cardiovascular Center. 408

The CMS Deputy State Health Officer for CMS or designee considers 409

existing facilities for continuing involvement upon the recommendation 410

of the CMS Cardiac Technical Advisory Panel and the criteria established 411

above. The Deputy State Health Officer for CMS or designee shall make 412

the final decision on whether or not a facility by continue such an 413

agreement with the Department of Health 414


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II. Standards for CMS Pediatric Cardiac Catheterization Laboratory 415

Component 416

A. The Pediatric Cardiac Catheterization Laboratory must be co-located within 417

a facility completely equipped to accommodate all aspects of the medical 418

and surgical care of the patient. 419

2012 American College of Cardiology Foundation/Society for 420

Cardiovascular Angiography and Interventions Expert Consensus Document 421

on Cardiac Catherization Laboratory Standards Update. J Am College 422

Cardiology. 2012;Vol. 59 No. 24 221-2305. 423

B. Cardiac Team 424

1. Physician in Charge 425

The physician in charge of the procedure must be board-certified by the 426

Sub-Board of Pediatric Cardiology of the American Board of Pediatrics 427

and have completed an additional 12 month fellowship in interventional 428

pediatric cardiology. Pediatric cardiologists either trained in other 429

countries or for any reason not eligible for certification by the Sub-Board 430

of Pediatric Cardiology of the American Board of Pediatrics may be 431

credentialed as a CMS physician by the Deputy State Health Officer for 432

CMS or designee, as a special situation after a review and in-depth 433

Deleted: . ¶434

Formatted: Font color: Red


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evaluation by the CMS Cardiac Technical Advisory Panel, which 435

recommended such approval. 436

2. Consulting Physicians 437

In addition to the physician listed above, in interventional cardiac 438

catheterizations, an anesthesiologist and a thoracic surgeon, each with 439

advanced training in the cardiovascular aspects of their specialty, must be 440

immediately available within the facility or in close proximity for 441

consultation, assistance, emergency and elective surgical procedures and 442

peri-operative care. 443

3. Nurse 444

Each laboratory must have a registered nurse, with special training in 445

cardiovascular techniques and in the care of children, as a full time 446

member of the team. This nurse must have special skills in pre-447

catheterization evaluation and instruction of the patient and family, care of 448

the patient post-catheterization, and discharge teaching for the patient and 449

family. 450

4. Cardiovascular Technologist 451

Each laboratory must have a cardiovascular technologist with special 452

training in cardiac catheterization laboratory techniques. 453


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5. Dedicated Trained Cardiovascular Recorder 454

Each laboratory must have a dedicated trained cardiovascular recorder 455

who has no other responsibilities during procedures. 456

6. Each laboratory must have immediate access to personnel trained in 457

equipment repair and maintenance. 458

7. Although the above required functions are well defined, it is not necessary 459

for one person to fulfill each separate job category. Well defined adequate 460

cross training for other personnel classifications permits 24-hour coverage 461

of essential team functions. 462

8. All technologists in a cardiovascular laboratory must be certified by the 463

Cardiovascular Credentialing Institute as a Registered Cardiovascular 464

Technologist (RCVT) and licensed by the State of Florida under the 465

Clinical Laboratory law, when applicable. 466

C. Equipment: Radiological, electronic, and computer-based systems are integral 467

components of the equipment in a catheterization laboratory. These systems 468

all require a program of rigorous maintenance and troubleshooting. For 469

pediatric patients, biplane angiography, higher frame rates (30-60 fps), and 470

higher injection rates (up to 40 mL/s) are required to help define abnormal 471


Deleted: ing 472


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intra-cardiac anatomy. The catheterization laboratory must be able to perform 473

procedures in a patient supported by extra corporeal membrane oxygenation. 474

2012 American College of Cardiology Foundation/Society for Cardiovascular 475

Angiography and Interventions Expert Consensus Document on Cardiac 476

Catherization Laboratory Standards Update. J Am College Cardiology. 477

2012;Vol. 59 No. 24 221-2305. 478

D. Electrical Safety and Radiation Protection 479

Electrical safety and radiation protection shall be followed in accordance with 480

the manufacturer’s recommendations and applicable State and Federal 481

regulations. 482

E. Records 483

1. Permanent record of real time study must include, at a minimum, video, 484

disk, chart, or digital / electronic recordings. 485

2. Interpretation and final approval of study reports must be performed by a 486

physician who is board certified in pediatric cardiology. 487

3. Medical records must be retained for a period of no less than seven (7) 488

years in a secure locked area. 489

F. Initial Evaluation 490


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1. Program Evaluation Review: When a request is received for participation 491

as a CMS Pediatric Cardiac Catheterization Laboratory facility, along with 492

attestation of compliance with all these standards, a program evaluation 493

and development review by members or designees of the CMS Cardiac 494

Technical Advisory Panel will be scheduled as the final component of the 495

application process. A request for participation shall not be deemed 496

complete until the Deputy State Health Officer for CMS or designee 497

receives the recommendation of the CMS Cardiac Technical Advisory 498

Panel. 499

2. Medical Records Review: A minimum of 25 consecutive pediatric cardiac 500

catheterization cases within a specified time period must be available to 501

warrant initial program evaluation and development review of any facility. 502

3. Facility Volume Standards: The minimum annual number of pediatric 503

cardiac catheterizations in a facility requesting to participate as a CMS 504

Pediatric Cardiovascular Center is 150 per facility (with a minimum of 50 505

interventional). 506


Cardiovascular Angiography and Interventions Expert Consensus 508

Deleted: 50509


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Document on Cardiac Catherization Laboratory Standards Update. J Am 510

College Cardiology. 2012;Vol. 59 No. 24 221-2305. 511

4. Practitioner Volume Standards: The minimum annual number of pediatric 512

cardiac catheterizations performed by each practitioner in a facility 513

requesting to participate as a CMS Pediatric Cardiovascular Center is 50 514

per year. Practitioners doing interventional procedures must do a 515

minimum of 25 interventional catheterizations per year. 516


Cardiovascular Angiography and Interventions Expert Consensus 518

Document on Cardiac Catherization Laboratory Standards Update. J Am 519

College Cardiology. 2012;Vol. 59 No. 24 221-2305. 520

5. Facility Criteria: include all standards in the CMS Pediatric Cardiac 521

Catheterization Laboratory Component section. 522

6. The CMS Deputy State Health Officer for CMS or designee considers new 523

facilities for involvement upon the recommendation of the CMS Cardiac 524

Technical Advisory Panel and all the criteria established above for 525

pediatric cardiac catheterizations. The Deputy State Health Officer for 526

CMS or designee shall make the final decision on whether or not a facility 527


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may continue such entering into an agreement with the Department of 528

Health. 529

G. Re-evaluation of CMS Facilities 530

1. Program Evaluation and Development Review: Each CMS Pediatric 531

Cardiac Catheterization Laboratory Facility must be evaluated on-site by 532

members or designees of the CMS Cardiac Technical Advisory Panel at a 533

minimum of once every three (3) years. The re-evaluation process is not 534



Panel. 537


catheterization cases must be available within a specified time period for 539

review at the time of the re-evaluation. 540

Facility Volume Standards: The minimum annual number of cardiac 541

catheterizations in a CMS Pediatric Cardiovascular Center is 150 per 542

facility (with a minimum of 50 interventional). If the facility volume is 543

below 150 for the twelve (12) month reporting period, the facility shall be 544

placed on probationary status for one (1) year. Probationary status may be 545

extended one (1) additional year if the facility documents a positive trend 546


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in meeting the volume standard. If the facility has not achieved the 547

volume standard at the end of a second year of probationary status, the 548

facility shall be provided with a notice of intent to end the agreement 549

between the CMS Pediatric Cardiovascular Center and the Department of 550

Health 551

3. Practitioner Volume Standards: By the first or subsequent three-year 552

program evaluation and development review, the minimum number of 553

cardiac catheterizations performed by each practitioner in a CMS Pediatric 554

Cardiovascular Center is 50 per year. Practitioners doing interventional 555

procedures must do a minimum of 25 interventional catheterizations per 556

year. 557

4. Facility Criteria: include all standards, other than facility volume 558

standards, in the CMS Pediatric Cardiac Catheterization Laboratory 559

Component section. 560

If the facility is not in compliance with all the required criteria other than 561

the volume standards, the facility must submit a corrective action plan for 562

approval by the Deputy State Health Officer for CMS or designee upon 563

the recommendation of the CMS Cardiac Technical Advisory Panel. If the 564

plan is approved, the facility shall be granted one-year probationary status. 565


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Probationary status may be extended one (1) additional year if the facility 566

documents improvements toward achieving all the facility criteria. If the 567

facility is not in compliance with all the facility criteria at the end of a 568

second year of probationary status, the facility shall be provided with a 569

notice of intent to end the agreement between the CMS Pediatric 570

Cardiovascular Center and the Department of Health. After the 90 day 571

patient care transition period, the facility will receive formal notice of the 572

end of the agreement between the CMS Pediatric Cardiovascular Center 573

and the Department of Health. 574

5. Data Submission: All Pediatric Cardiac Catheterization Laboratories must 575

collect and submit quality assurance data to IMPACT and annually in 576

accordance with the following CMS forms: 577

Pediatric Cardiac Catheterization Procedures (DH-CMS 2057, 578

10/20XX); and 579

Cardiac Catheterization Cases--Primary Cardiac Diagnoses (DH-580

CMS 2058, 10/20XX). 581


the facility or CMS, a 90 day notice shall be provided to the CMS 583

Pediatric Cardiovascular Center. 584


Deleted: All CMS585


August 2014

32

7. The CMS Deputy State Health Officer for CMS or designee considers 586

existing facilities for continuing involvement based upon the 587

recommendation of the CMS Cardiac Technical Advisory Panel and all 588

the criteria established above. The Deputy State Health Officer for CMS 589

or designee shall make the final decision on whether or not a facility may 590

continue such an agreement with the Department of Health. 591

592

III. Standards for CMS Pediatric Cardiac Electrophysiology (EP) Programs 593

A Pediatric Cardiac Electrophysiology (EP) Program is an integral part of a 594

CMS Pediatric Cardiovascular Center. The EP program has two main 595

components: (1) An Interventional program in a Pediatric Cardiac 596

Electrophysiology Laboratory and (2) an outpatient arrhythmia evaluation and 597

management service. 598

An institution participating as a CMS Pediatric Cardiovascular Center, may 599

elect not to participate in both components of these EP Standards. 600

All CMS designated centers must participate in the outpatient arrhythmia 601

evaluation and management services. 602

If an institution elects not to participate in the EP interventional program in a 603

pediatric cardiology electrophysiology laboratory, it must have a written 604


August 2014

33

format establishing an effective triage to another CMS EP facility as defined 605

below. Such a protocol must include a formal document signed by the CEO’s 606

of both involved institutions and approved by the CMS Deputy State Health 607

Officer for CMS or designee. 608

609

A. Laboratory Component: The Pediatric Cardiac Electrophysiology Laboratory 610

must be co-located within a facility completely equipped to accommodate all 611

aspects of the medical and surgical care of the pediatric patient. 612

1. Cardiac Team 613

i) Physician in Charge: The physician in charge of the laboratory must be 614

board-certified by the Sub-Board of Pediatric Cardiology of the 615

American Board of Pediatrics and must be a pediatric 616

electrophysiologist as defined below: 617

a) Pediatric Electrophysiologist is a Pediatric Cardiology Board 618

Certified physician, whose primary clinical practice is dedicated to 619

pediatric electrophysiology activities. 620

b) In addition, the individual to be credentialed by CMS as a pediatric 621

electrophysiologist must meet the International Board of Heart 622

Rhythm Examiners (IBHRE) board eligibility criteria by meeting 623


August 2014

34

or exceeding the requirements outlined by one or both of the tracks 624

outlined below: 625

International Board of Heart Rhythm Examiners. Eligibility 626

Requirements Policy: IBHRE Board Certification Examination in 627

Cardiac Electrophysiology for the Physician 10.29.2010 628

Pediatric Electrophysiologist: Credentials 629

1) Track 1: Training Completed After July 1, 2005 630

(i) Successful completion of a pediatric cardiovascular 631

medicine fellowship program and board-certified in 632

Pediatric Cardiology by the American Board of Pediatrics. 633

(ii) Successful completion of a minimum of 1 additional year 634

of cardiac electrophysiology training in a pediatric 635

electrophysiology fellowship program. The training 636

program must meet the minimum criteria set forth by the 637

task force in pediatric cardiology training. ACCF/AHA/AAP 638

Recommendations for Training in Pediatric Cardiology. 639

A Report of the American College of Cardiology 640

Foundation/American Heart Association/American 641

Committee to Develop Training Recommendations for 642


August 2014

35

Pediatric Cardiology) College of Physicians Task Force on 643

Clinical Competence Circulation. 2005;112:2555-2580 644

(iii)In addition, the electrophysiologist must monitor on a 645

continuing basis at least 30 patients with implanted devices. 646

However, the involved pediatric electrophysiologist does 647

not necessarily have to perform all such device 648

implantations 649

2) Track 2: Training Completed Before July 1, 2005 650

(i) Pediatric EP applicants completing training prior to July 1, 651

2005 may qualify either by satisfying Track 1 requirements 652

above, or by demonstrating a minimum level of practice 653

experience consisting of at least 5 years of active pediatric 654

electrophysiology experience, in which the applicant’s 655

primary clinical interest is pediatric electrophysiology. The 656

candidate must be actively involved in the management and 657

care of pediatric arrhythmia patients. 658

(ii) Past Experience: 659

(a) A minimum 5 year history of practicing pediatric 660

electrophysiology as his or her primary clinical interest. 661


August 2014

36

(b) In that 5 year span, performance of a minimum of 150 662

EP studies of which at least 90 or 60% of the total must 663

have been catheter ablation procedures. 664

ACCF/AHA/AAP Recommendations for Training in 665

Pediatric Cardiology. A Report of the American College 666

of Cardiology Foundation/American Heart 667

Association/American Committee to Develop Training 668

Recommendations for Pediatric Cardiology) College of 669

Physicians Task Force on Clinical Competence 670

Circulation. 2005;112:2555-2580 671

(c) In addition, the individual must monitor on a continuing 672

basis at least 30 patients with implanted devices. 673

However, the involved pediatric electrophysiologist 674

does not necessarily have to perform any or all such 675

device implantations. 676

3) Foreign Trainees: Pediatric cardiologists either trained in other 677

countries, or for any other reason not eligible for certification 678

by the Sub-Board of Pediatric Cardiology of the American 679

Board of Pediatrics may be credentialed as a CMS physician 680


August 2014

37

specializing in electrophysiology by the Deputy State Health 681

Officer for CMS or designee as a special situation after a 682

review and in-depth evaluation by the CMS Cardiac Technical 683

Advisory Panel, which recommended such credentialing. 684

ii) Consulting Physicians: In addition to the physician listed above, in 685

interventional EP cardiac catheterizations, an anesthesiologist and a 686

thoracic surgeon, each with advanced training in the cardiovascular 687

aspects of their specialty, must be immediately available within the 688

facility, or in close proximity, for consultation, assistance, emergency 689

and elective surgical procedures and peri-operative care. 690

iii) Nurse: Each laboratory must have a registered nurse, with special 691

training in cardiovascular techniques and in the care of children, as a 692

full time member of the team. This nurse must have special skills in 693

pre and post catheterization evaluation, and management. In addition, 694

this individual must have skills in and be able to coordinate patient and 695

family education and instructions pre and post procedure. 696

iv) Cardiovascular EP Technologist: Each laboratory must have a 697

cardiovascular EP technologist with special training in cardiac EP 698

laboratory techniques. 699


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v) Dedicated Trained Cardiovascular EP Recorder: 700

a) Each laboratory must have a dedicated trained cardiovascular EP 701

recorder who has no other responsibilities during such 702

procedures. 703

b) Each laboratory must have immediate access to personnel trained 704

in equipment repair and maintenance. 705

c) Although the above-required functions are well defined, it is not 706

necessary for one person to fulfill each separate job category. 707

Adequate cross training for other personnel classifications 708

permits 24-hour coverage of essential team functions. 709

d) All technologists in a cardiovascular laboratory must be certified 710

by the Cardiovascular Credentialing Institute as a Registered 711

Cardiovascular Technologist (RCVT) and licensed by the State 712

of Florida under the Clinical Laboratory law, when applicable. 713

2. Equipment: 714

i) Radiological, electronic, and computer-based systems are integral 715

components of the equipment in a catheterization laboratory. These 716

systems all require a program of rigorous maintenance and 717


August 2014

39

troubleshooting. In addition, a pediatric electrophysiology laboratory must 718

have: 719

a) Multi Channel EP recording system 720

b) External Defibrillation system 721

c) Cardiopulmonary monitoring system 722

d) Radiofrequency Energy Source 723

e) It is strongly recommended that Pediatric Electrophysiology 724

laboratories also have: 725

1) 3 Dimensional Mapping System 726

2) Cryo ablation System 727

ii) Electrical Safety and Radiation Protection: Electrical safety and radiation 728

protection shall be followed in accordance with the manufacturer’s 729

recommendations and applicable State and Federal regulations. 730

3. Records 731

i) Permanent record of real time study must include, at a minimum, video, 732

disk, chart, or digital / electronic recordings. 733

ii) Interpretation and final approval of such EP study reports must be 734

performed by a physician who is board certified in pediatric cardiology 735


August 2014

40

and meets the standards to be qualified as a pediatric electrophysiologist, 736

as defined previously. 737

iii) Medical records must be retained for a period of no less than seven (7) 738

years in a secure locked area. 739

4. Initial Evaluation 740

i) Program Evaluation and Development Review: When a request is 741

received for participation as a CMS Pediatric Cardiac Electrophysiology 742

Laboratory facility, along with attestation of compliance with all these 743

standards, a program evaluation and development review by members or 744

designees of the CMS Cardiac Technical Advisory Panel will be scheduled 745

as the final component of the application process. An application shall not 746

be deemed complete until the Deputy State Health Officer for CMS or 747

designee receives the recommendation of the CMS Cardiac Technical 748

Advisory Panel. 749

ii) Medical Records Review: 750

a) A minimum of 12 consecutive pediatric cardiac catheterization 751

electrophysiologic studies within a year must be available to warrant 752

initial inspection of any facility. 753


August 2014

41

b) A minimum of 7 consecutive pediatric implantable device insertions 754

(pacemakers and / or Implantable Cardioverter Defibrillators) studies 755

within a year must be available to warrant initial inspection of any 756

facility. 757

iii) Facility Volume Standards: Facilities shall be evaluated independently for 758

two separate areas of expertise within a pediatric electrophysiology 759

program: EP studies with ablations and device insertions. 760

a) EP studies and ablation: The minimum annual number of pediatric 761

electrophysiologic studies in an applicant facility is recommended to 762

be at least 30 per facility with a minimum of 18 ablations, or 60% of 763

the total number of studies per year. 764

Source: PACES SURVEY, 2012 765

b) Device implantations: Pacemaker and / or Implantable - Cardioverter 766

Defibrillators (ICD) insertions. The minimum number of device 767

implantations (pacemakers and /or ICD’s) in an applicant facility is 768

recommended to be at least 10 per year. For the purpose of facility 769

volume standards, device insertions may be performed by either a 770

credentialed CMS pediatric cardiovascular surgeon and /or a 771

credentialed CMS pediatric electrophysiologist. 772


August 2014

42

iv) Practitioner Volume Standards: 773

a) Pediatric electrophysiologists shall be evaluated independently for two 774

separate areas of expertise within a pediatric electrophysiology 775

program: EP Studies with Ablations and Device Insertions 776

b) A practitioner may choose to be credentialed to perform EP Studies / 777

Ablations and Device insertions, or both. 778

1) The minimum annual number of pediatric cardiac 779

electrophysiologic studies performed by each practitioner in an 780

applicant facility is recommended to be at least 30 per year, of 781

which at least 18, or 60% of the total number of studies per year, 782

are catheter ablation procedures. 783

2) The minimum annual number of pediatric device implants 784

(pacemaker and/ or ICD) performed by each practitioner in an 785

applicant facility is recommended to be at least 10 per year. 786

Electrophysiology Society Clinical Competency Statement: 787

Training pathways for implantation of cardioverter-defibrillators 788

and cardiac resynchronization therapy devices in pediatric and 789

congenital heart patients. Developed in collaboration with the 790

American College of Cardiology and the American Heart 791


August 2014

43

Association. J. Philip Saul, MD, FHRS, Victoria L. Vetter, MD, 792

Heart Rhythm, Vol 5, No 6, June 2008 793

(i) Practitioners whose volume falls below 10 per year must then 794

demonstrate that they have an established working relationship 795

with either a credentialed CMS pediatric cardiovascular 796

surgeon or a credentialed CMS pediatric electrophysiologist 797

performing device implants or an adult electrophysiologist 798

trained in device implantation, and demonstrate that such 799

physicians are available in case they are needed. 800

v) Outcomes Standards: 801

The members of the CMS Cardiac Technical Advisory Panel’s EP Task 802

Force will develop and recommend that all CMS Cardiac Centers 803

participate in a database into which the involved EP physicians would 804

report the outcomes of their EP Studies and device insertions. Such 805

database recommendations will be submitted to the CMS Cardiac 806

Technical Advisory Panel and implemented if the Panel supports such 807

recommendations. 808

a) Outcomes Standards- Initial Phase 809


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44

1) Initially, CMS Pediatric Electrophysiology programs will be 810

evaluated utilizing existing outcome expectations based on current 811

literature, with the understanding that more data needs to be 812

generated which incorporates modern technologies and 813

expectations. 814

2) The presently appointed Florida CMS EP Task Force will create a 815

pilot data-tracking tool, which will serve as a preliminary data 816

repository. This will be implemented after a recommendation by 817

the CMS Cardiac Technical Advisory Panel to, and approval by, 818

the Director of the Division of Children’s Medical Services or 819

his/her designee. 820

(i) Supraventricular Tachycardia (SVT) or Ventricular Tachycardia 821

(VT) ablation outcomes in post-surgical or abnormal anatomy 822

substrate. Acceptable success and complication standards are 823

not yet defined. However, each will be reported for ongoing 824

analysis 825

(ii) Endocardial Device Insertion Procedures. Acceptable success 826

and complication rates are not yet defined in the pediatric 827


August 2014

45

population. However, outcomes will be reported for ongoing 828

analysis. 829

(iii)Epicardial Device Insertion procedures are considered cardiac 830

surgeries and outcomes evaluated in the context of the involved 831

cardiovascular surgical program. 832

b) Outcomes Standards- Second Phase: 833

1) When a proposed national database (MAP-IT) is implemented and 834

incorporated into the existing national cardiac catheterization 835

database (IMPACT), the existing CMS EP data tracking tool is 836

strongly recommended to be incorporated into this national 837

database. All CMS pediatric cardiovascular centers are strongly 838

recommended to participate and report their data to the MAP-IT 839

national database when implemented. 840

2) When national outcome standards are defined, they will be 841

submitted to the CMS Cardiac Technical Advisory Panel as the 842

new outcome standards for Florida CMS pediatric 843

electrophysiology centers. 844

3) Once procedural success and complication rates are measured and 845

published, the CMS EP Task force shall recommend that 846


August 2014

46

acceptable program and or practitioner volume and outcomes are 847

within two standard deviations from the national mean. This 848

recommendation shall be presented to the CMS Cardiac Technical 849

Advisory Panel and submitted for incorporation into the present 850

Rules by the Director of the Division of Children’s Medical 851

Services or his/her designee. Once these new volume and outcome 852

standards are incorporated into the present Rules, programs whose 853

volume or outcomes are below the new standards shall be subject 854

to increased surveillance and potential probationary status as 855

defined below. 856

vi) Facility Criteria: Includes all standards in the CMS Pediatric Cardiac 857

Catheterization Laboratory Component section. 858

vii) The Deputy State Health Officer for CMS or designee considers new 859

facilities for involvement in the CMS cardiac program upon the 860

recommendation of the CMS Cardiac Technical Advisory Panel after 861

meeting all the criteria established above for such pediatric cardiac 862

catheterizations. The Deputy State Health Officer for CMS or designee 863

shall make the final decision on whether to approve an applicant to be a 864

Center. 865


August 2014

47

5. Re-evaluation of CMS Centers: 866

a) Program Evaluation and Development Review: Each CMS Pediatric Cardiac 867

Electrophysiology Laboratory Facility must be evaluated on-site by members 868

or designees of the CMS Cardiac Technical Advisory Panel at a minimum of 869

once every three (3) years. The re-evaluation process is not complete until the 870

Deputy State Health Officer for CMS or designee receives the 871

recommendations of the CMS Cardiac Technical Advisory Panel. 872

b) Medical Record Review: A minimum of 12 consecutive pediatric cardiac 873

electrophysiologic studies must be available within a specified time period for 874

review at the time of the re-evaluation. Volume Standards are as follows: 875

c) Facility Volume Standards: The minimum annual number of pediatric 876

electrophysiologic studies in an applicant facility is recommended to be at 877

least 30 per facility with a minimum of 18 ablations, or 60% of the total 878

number of studies per year. 879

d) Practitioner Volume Standards: 880

(i) By the first or subsequent three-year review, the minimum annual number 881

of pediatric cardiac electrophysiologic studies performed by each 882

practitioner in an applicant facility is recommended to be at least 30 per 883


August 2014

48

year, of which at least 18, or 60% of the total number of studies per year 884

are catheter ablation procedures. 885

(ii) Pediatric electrophysiologists performing device implantations are 886

recommended to perform at least 10 device implantation procedures per 887

year. 888

e) During the initial phase of the development of outcomes standards, defined in 889

Section III.A.4.v)a), EP facilities will be evaluated by examining their 890

completeness of data submission. During this initial phase, the primary 891

evaluative assessment will be procedural outcomes as deemed acceptable 892

based on existing literature. 893

f) The second phase of outcomes evaluation, Section III.A.4.v)b), will be 894

completed once national standards are derived from national databases into 895

which all Florida EP programs are expected to submit their data. National 896

volume and outcome standards, once created, will be recommended by the EP 897

Task force to the CMS Cardiac Technical Advisory Panel and submitted for 898

approval by the Deputy State Health Officer for CMS or designee. Once 899

approved, then these will become the volume and outcome standards by which 900

each program is to be evaluated. 901


August 2014

49

g) If the site review team determines the facility meets acceptable standards and 902

has acceptable outcomes, then the facility and practitioner will be subject to 903

be a component of the three year review cycle of CMS Pediatric 904

Cardiovascular Centers. 905

h) If the facility is below acceptable standards and with less than acceptable 906

outcomes, then the facility will be reviewed by the CMS Cardiac Technical 907

Advisory Panel which may recommend that the facility be placed on 908

probationary status for one year. Probationary status may be extended one (1) 909

additional year if the facility documents a positive trend in meeting the 910

outcomes standard. If the facility has not achieved the acceptable outcomes 911

standard at the end of a second year of probationary status, the facility shall be 912

provided with a notice of intent to end the agreement between the CMS 913

Pediatric Cardiovascular Center and the Department of Health. After a 90 day 914

transition period, the facility will receive a formal notice to end the agreement 915

between the CMS Pediatric Cardiovascular Center and the Department of 916

Health. 917

B. Outpatient Clinic Component 918


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50

1. Facility Criteria: include all standards, as outlined in the outpatient clinic 919

section. In addition, an outpatient electrophysiology program must have 920

the following components: 921

i) Personnel: 922

a) The physician in charge of this clinic is to be board certified in 923

Pediatric Cardiology and Basic Life Support and have special 924

expertise in arrhythmias and device management 925

b) The involved nurse/technician is to have special expertise in device 926

management and be certified in both Basic Life Support and 927

Pediatric Advanced Life Support. 928

ii) Device Management: Pacemaker, Implantable Cardioverter 929

Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT ) 930

device monitoring is performed by combining both in-clinic and 931

remote (home) monitoring. Criteria for intervals for device follow-up 932

must recognize that the complexity of the underlying heart disease 933

dictates the intervals for such surveillance. A reasonable guide for in-934

clinic monitoring is as follows: 935

a) Antibradycardia devices: At a minimum, the patient will be seen in 936

the clinic one week and then 3 months post implant. Then the 937


August 2014

51

patient should be seen no less frequently than annually as long as 938

clinic visits are supplemented by remote monitoring from home no 939

less frequently than every three months, and more frequently as 940

may be clinically indicated. Complexity of the issues managed or 941

device related issues may require a more intensive and frequent 942

monitoring schedule. Evaluation of surgical site may be performed 943

by physicians in the patient’s local community when deemed 944

appropriate. 945

b) ICD and CRT devices: At a minimum, the patient will be seen in 946

the clinic within one week and then 3 months post implant. Then 947

the patient should be seen no less frequently than bi-annually as 948

long as clinic visits are supplemented by remote monitoring from 949

home no less frequently than every three months, and more 950

frequently as may be clinically indicated. Complexity of the issues 951

managed; or device related issues, may require a more intensive 952

and frequent monitoring schedule. Evaluation of surgical site may 953

be performed by physicians in the patient’s local community when 954

deemed appropriate. 955


August 2014

52

2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for 956

Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report 957

of the American College of Cardiology Foundation/American 958

Heart Association Task Force on Practice Guidelines Cynthia M. 959

Tracy, MD et al. J Am Coll Cardiol. 2012;60(14):1297-1313. 960

iii) Equipment 961

a) For in-clinic monitoring – the following items must be available: 962

Electrocardiographic (EKG) recording machine, External 963

Defibrillator, Device programmers for: Pacemakers, Implantable-964

Cardioverter Defibrillators (ICD’s) and Cardiac Resynchronization 965

Therapy (CRT’s). 966

b) For remote monitoring, some form of surveillance must be 967

available including traditional trans-telephonic monitoring (TTM). 968

iv) Volume: It is recommended that the involved EP physicians should 969

have managed, in their professional career, at least 75 patients with 970

devices and maintained competence by performing 30 assessments 971

annually. 972


August 2014

53

v) Records: A complete database of patients with devices should be 973

maintained and to include all device models and ID numbers, Lead 974

models and ID numbers. 975

a) A permanent record of real time study of serial device testing must 976

be maintained and kept for at least 7 years. 977

vi) Arrhythmia Management 978

a) Pediatric Electrophysiology clinics must be staffed by a pediatric 979

electrophysiologist and at least one skilled nurse. Visit frequency is 980

dictated individually by the severity of the arrhythmia. 981

1) Visits are recommended to include: 982

(i) Antiarrhythmic drug management, verification of drug 983

dosages and drug- drug interactions 984

(ii) Surveillance of arrhythmia monitoring tests which may 985

include a 12 lead electrocardiogram, Holter monitor 986

electrocardiography, event or memory loping monitors, and 987

a stress test. 988

(iii)Cardiac channelopathy patients are monitored as frequently 989

as the specific disease requires. Proper management of 990

these syndromes is recommended to include genetic testing 991


August 2014

54

of the proband followed by family specific testing, and 992

genotype specific drug management and counseling. 993

vii) Evaluation of Participating Facilities: 994

1) If the facility is not in compliance with all the required personnel 995

and equipment criteria as described previously, the facility must 996

submit a corrective action plan for approval by the Deputy State 997

Health Officer for CMS or designee upon the recommendation of 998

the CMS Cardiac Technical Advisory Panel. If the plan is 999

approved, the facility shall be granted a one-year probationary 1000

status. Probationary status may be extended one (1) additional year 1001

if the facility documents improvements toward achieving all the 1002

facility criteria. If the facility is not in compliance with all the 1003

facility criteria at the end of a second year of probationary status, 1004

the facility shall be provided with a notice of intent to end the 1005

agreement between the CMS Pediatric Cardiovascular Center and 1006

the Department of Health. After a 90 day transition period, the 1007

facility will receive a formal notice to end the agreement between 1008

the CMS Pediatric Cardiovascular Center and the Department of 1009

Health. 1010


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55

2) Data Submission: The staff of all CMS Pediatric Cardiac 1011

Electrophysiology Centers must collect and submit quality 1012

assurance data annually in accordance with the following CMS 1013

forms: 1014

(i) Cardiac Catheterization Procedures (DH-CMS 2057, 1015

10/20XX); 1016

(ii) Cardiac Catheterization Cases--Primary Cardiac Diagnoses 1017

(DH-CMS 2058, 10/20XX); and 1018

(iii)Pediatric Cardiac Electrophysiology Laboratories (DH-CMS 1019

XXXX, XX/XX). 1020

The Deputy State Health Officer for CMS or designee considers existing facilities for 1021

continuing involvement based upon the recommendation of the CMS Cardiac Technical 1022

Advisory Panel and all the criteria established above. The Deputy State Health Officer for 1023

CMS or designee shall make the final decision as to whether or not to continue such an 1024

agreement with the Department of Health 1025

IV. Standards for CMS Pediatric Cardiovascular Surgery Program Component 1026

A. Diagnosis and treatment are so closely related that a CMS Pediatric 1027

Cardiovascular Surgery Program, CMS Pediatric Cardiac Catheterization 1028


August 2014

56

Laboratory Component and a CMS Pediatric Cardiology Clinic Component 1029

must be co-located on the same campus. 1030

B. General pediatric coverage with sub-specialty capability twenty-four hours a 1031

day, seven days a week. 1032

C. An effective system (with documentation) of rapid referral and transportation. 1033

D. Cardiac Team - Pediatric Cardiovascular Surgery Program must have 1034

accredited pediatric and general surgery training programs with house staff or 1035

must have other arrangements to provide 24-hour physician or house staff 1036

coverage. 1037

1. A CMS credentialed thoracic and cardiovascular surgeon with special 1038

training, interest and experience with pediatric cardiac patients and 1039

certification by the American Board of Thoracic Surgery. All such 1040

surgeons will have 5 years to become Board Certified after becoming 1041

eligible for such an examination. 1042

2. CMS credentialed associate thoracic and cardiovascular surgeon with 1043

special training interest and experience with pediatric cardiac patients and 1044

certification by the American Board of Thoracic Surgery. Such an 1045

associate surgeon should be either “on-site”, available through an 1046

established agreement with another CMS Pediatric Cardiovascular Center, 1047


August 2014

57

or available by an established organizational format approved by the 1048

Deputy State Health Officer for CMS or designee. 1049

3. In regards to the above thoracic and cardiovascular surgeons, since the 1050

new Sub-Board of Pediatric Cardiovascular Surgery under the American 1051

Board of Thoracic Surgery is now fully implemented, each surgeon who 1052

started such training after July 1, 2008 must be certified by this new Board 1053

within 5 years of becoming eligible. 1054

4. Pediatric cardiovascular surgeons, either trained in other countries or for 1055

any other reason not eligible for certification by the American Board of 1056

Thoracic Surgery, or the new Sub-Board of Pediatric Cardiovascular 1057

Surgery, may be credentialed as a CMS physician by the DeputyState 1058

Health Officer for CMS or designee as a special situation after a review 1059

and in-depth evaluation by the CMS Cardiac Technical Advisory Panel, 1060

which recommended such approval. 1061

5. Pediatric sub-specialists with expertise in hematology, nephrology, 1062

neurology, infectious disease, critical care and pulmonology must be 1063

available for consultation and management of patients with heart disease. 1064

6. Radiologist trained in cardiopulmonary disease. 1065


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7. Anesthesiologist with training and experience in open and closed heart 1066

pediatric anesthesia. 1067

8. Respiratory Therapist with training and experience in short and long-term 1068

ventilatory support in infants and children. 1069

9. Technicians available 24 hours a day for laboratory and radiology 1070

procedures. 1071

10. Perfusionist who is certified by the American Board of Cardiovascular 1072

Perfusion in the area of cardiovascular perfusion. 1073

11. Specially trained nurses for preoperative evaluation and instruction of the 1074

patient and family, intensive care, and convalescent care. 1075

12. Pathologist with skills and training in cardiovascular pathology. 1076

13. The facility must identify and utilize a core surgical team. 1077

14. Involved staff will make a priority of maintaining on-going 1078

communication throughout the patient’s hospital course with the patient’s 1079

primary care physician. 1080

15. Continuous availability of a team skilled in performing intra-operative 1081

TEE’s to aid in the post-surgical assessment of operative procedures. 1082

16. Availability of Extra Corporeal Life Support (ECLS) 1083

E. Pre-operative Preparation 1084


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59

1. Dedicated pediatric patient rooms with provision for a parent, relative or 1085

guardian to remain overnight with hospitalized child. 1086

2. Clear instructions to parents and patient with pre-operative visits to 1087

catheterization laboratory, intensive care unit, and other sites as needed, 1088

consistent with their ability to comprehend. 1089

3. Care management conference between the pediatric cardiologist, pediatric 1090

cardiovascular surgeon, and other professional staff as necessary 1091

documented in the patient record. 1092

F. Post-operative Care 1093

1. All post-operative care must be under the direction of the involved CMS 1094

credentialed cardiovascular surgeons in constant (24/7) communication with, 1095

and in support of, the post-operative cardiovascular team composed of 1096

pediatric intensivists, cardiologists, neonatologists, anesthesiologists, and 1097

other personnel as needed. In certain cases, the involved pediatric 1098

cardiovascular surgeon may transfer primary responsibilities to another 1099

member of the team, such as cases with arrhythmias, or neonates on Extra 1100

Corporeal Membrane Oxygenation (ECMO) in the neonatal intensive care 1101

unit (NICU). 1102


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2. Each CMS Pediatric Cardiovascular Surgical Facility must have a 1103

dedicated Pediatric Cardiovascular Intensive Care Unit with personnel 1104

specially trained in Congenital Heart Surgery, including physicians, nurses, 1105

respiratory specialists, and ancillary staff. Such a unit may be either a 1106

separate cardiac ICU or a dedicated component within a Pediatric Intensive 1107

Care Unit. 1108

Guidelines for Pediatric Cardiovascular Centers: Pediatrics. 2002: Vol. 109 1109

No. 3 544-549 1110

G. Initial Evaluation 1111

1. Program Evaluation and Development Review: When a request is 1112

received for involved as a CMS pediatric cardiovascular surgery facility, 1113

along with attestation of compliance with all these standards, a program 1114

evaluation and development review by members or designees of the CMS 1115

Cardiac Technical Advisory Panel shall be scheduled as the final 1116

component of the application process. An application shall not be deemed 1117

complete until the Deputy State Health Officer for CMS or designee for 1118

CMS or designee receives the recommendation of the CMS Cardiac 1119

Technical Advisory Panel. 1120


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2. Medical Records Review: A minimum of 25 consecutive pediatric cardiac 1121

surgical cases must be available within a specified time period to warrant 1122

initial program evaluation and development review of any facility. 1123

Facility Volume Standard: The minimum annual (12 consecutive 1124

months) number of pediatric cardiac surgeries in a facility requesting to 1125

become a CMS Pediatric Cardiovascular Center is 101 index cardiac 1126

operations as defined by Society of Thoracic Surgeons (STS). 1127

Additionally, each center must do 90 open heart cases in a 12 month 1128

period, i.e. on Cardiopulmonary (CB) bypass. Open heart cases are now 1129

counted by CMS criteria not STS criteria. Thus, multiple CB operations, 1130

on the same patient during the same admission count individually. 1131

Surgical Volume for Pediatric and Congenital Heart Surgery: Total 1132

Programmatic Volume and Programmatic Volume Stratified by Five STS-1133

EACTS Mortality Levels: NATIONAL QUALITY FORUM. Measure 1134

Evaluation 4.1 2009;1-21. 1135

Association of Center Volume With Mortality and Complications in 1136

Pediatric Heart Surgery: Pediatrics 2012:129; e370-e376 1137

1138


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An empirically based tool for analyzing mortality associated with congenital 1139

heart surgery. The Journal of Thoracic and Cardiovascular Surgery. 2009: 1140

Vol. 138 No. 5; 1139-1153 1141

i) NATIONAL VOLUNTARY CONSENSUS STANDARDS FOR 1142

PEDIATRIC CARDIAC SURGERY: A CONSENSUS REPORT. 1143

National Quality Forum 2012: 1-18.For the purposes of counting 1144

cardiac surgical volume in a CMS Pediatric Cardiovascular Center, 1145

CMS further defines pediatric cardiac surgeries to include the 1146

following: 1147

a) Cardiac Surgery: Cardiac surgical cases performed by each 1148

facility’s pediatric cardiovascular surgeon(s), including: 1149

1) Only cardiac operations count, as defined by the STS 1150

Congenital Heart Surgery Database as CPB (Cardio 1151

Pulmonary By-Pass) or No CPB Cardiovascular; 1152

2) Cardiac surgeries performed on pediatric patients (pediatric 1153

patient is defined by the Society of Thoracic Surgeons 1154

Database as from birth to 18 years of age); 1155

3) Cardiac surgeries performed on adult heart disease patients 1156

in whom the primary component is congenital; 1157


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4) Non-cardiac surgeries performed on cardiopulmonary by-1158

pass by the facility’s pediatric cardiovascular surgeon(s); 1159

5) Surgical closure of a patent ductus arteriosus, including all 1160

premature infants, regardless of age; 1161

6) Placement of a cardiac pace-maker or defibrillator, in 1162

which the facility’s pediatric cardiovascular surgeon(s) is 1163

the primary physician of record; and 1164

7) Hybrid cardiac cases involving a surgical component. 1165

b) Additionally, the following procedures are NOT considered 1166

when determining cardiac surgical volume: 1167

1) Cardiac surgeries not performed by the facility’s pediatric 1168

cardiovascular surgeon(s); 1169

2) Delayed sternal closure; 1170

3) Re-exploration of the mediastinum; for example, excessive 1171

bleeding; 1172

4) Operations where ECMO cannulation or decannulation is 1173

the primary procedure and any operations classified by the 1174

STS Congenital Heart Surgery Database as Operation Type 1175

= ECMO; and 1176


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5) Any operation classified by the STS Congenital Heart 1177

Surgery Database as an Operation Type other than CPB 1178

(CPB = Cardio Pulmonary = By-Pass) or No CPB 1179

Cardiovascular. 1180

ii) To further clarify surgical volume for the purposes of CMS volume 1181

requirements, surgical volume should be calculated based on each 1182

cardiac surgical admission that involves a cardiac surgical 1183

operation. For example, if patient A comes to the facility and has a 1184

cardiac operation and then has a second cardiac operation later but 1185

during the same admission, that would be counted as one surgery. 1186

As another example, if patient B has multiple component 1187

procedures performed during the same cardiac operation, that 1188

would also be counted as one operation. Such guidelines are 1189

identical to the rules used by The Society of Thoracic Surgeons 1190

Database to calculate programmatic volume using index cardiac 1191

operations. CMS utilizes such national standards whenever 1192

available. 1193

3. The facility must be co-located with a CMS Pediatric Cardiology Clinic 1194

Facility and a CMS Pediatric Catheterization facility. 1195


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4. Facility Criteria: include all standards in the CMS Pediatric 1196

Cardiovascular Surgery Program Component section. If the facility is not 1197

in compliance with all the required criteria other than the volume 1198

standards, the facility must submit a corrective action plan for approval by 1199

the Deputy State Health Officer for CMS or designee upon the 1200

recommendation of the CMS Cardiac Technical Advisory Panel. If the 1201

plan is approved, the facility shall be granted a one (1) year probationary 1202

status. Probationary status may be extended one (1) additional year if the 1203

facility documents improvements toward achieving all the facility criteria. 1204

If the facility is not in compliance with all the facility criteria at the end of 1205

a second year of probationary status, the facility shall be provided with a 1206

notice of intent to end the agreement between the CMS Pediatric 1207

Cardiovascular Center and the Department of Health. 1208

5. The Deputy State Health Officer for CMS or designee considers new 1209

facilities for involvement upon the recommendation of the Cardiac 1210

Technical Advisory Panel and after fulfilling all criteria established above 1211

for pediatric cardiac surgery. The Deputy State Health Officer for CMS or 1212

designee shall make the final decision on whether or not a facility may 1213

continue such an agreement with the Department of Health. 1214


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H. Re-evaluation of Approved Facilities 1215

1. Program Evaluation and Development Review: Each CMS Pediatric 1216

Cardiovascular Surgical Facility must be re-evaluated on-site by members 1217

or designees of the CMS Cardiac Technical Advisory Panel at a minimum 1218

of once every three (3) years. The process of re-evaluation is not 1219



Panel 1222


surgical cases must be available within a specified time period for review 1224

at the time of the re-evaluation. 1225

3. Facility Volume Standard: By the first and all subsequent three year 1226

program evaluation and development reviews, the minimum annual 1227

number of pediatric cardiac surgeries for a CMS Pediatric Cardiovascular 1228

Center is 101,at least 90 of which must be cases involving open heart 1229

surgery 1230

i) For the purposes of counting cardiac surgical volume in a CMS 1231

Pediatric Cardiovascular Center, CMS further defines pediatric 1232

cardiac surgeries to include the following: 1233


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a) Cardiac Surgery: Cardiac surgical cases performed by each 1234

facility’s pediatric cardiovascular surgeon(s), including: 1235

1) Only cardiac operations count, as defined by the STS 1236

Congenital Heart Surgery Database as CPB (Cardio 1237

Pulmonary By-Pass) or No CPB Cardiovascular; 1238

2) Cardiac surgeries performed on pediatric patients (pediatric 1239

patient is defined by the Society of Thoracic Surgeons 1240

Database as from birth to 18 years of age); 1241

3) Cardiac surgeries performed on adult heart disease patients 1242

in whom the primary component is congenital; 1243

4) Non-cardiac surgeries performed on cardiopulmonary by-1244

pass by the facility’s pediatric cardiovascular surgeon(s); 1245

5) Surgical closure of a patent ductus arteriosus, including all 1246

premature infants, regardless of age; 1247

6) Placement of a cardiac pace-maker or defibrillator, in 1248

which the facility’s pediatric cardiovascular surgeon(s) is 1249

the primary physician of record; and 1250

7) Hybrid cardiac cases involving a surgical component. 1251


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68

b) Additionally, the following procedures are NOT considered 1252

when determining cardiac surgical volume: 1253

1) Cardiac surgeries not performed by the facility’s pediatric 1254

cardiovascular surgeon(s); 1255

2) Delayed sternal closure; 1256

3) Re-exploration of the mediastinum; for example, excessive 1257

bleeding; 1258

4) Operations where ECMO cannulation or decannulation is 1259

the primary procedure and any operations classified by the 1260

STS Congenital Heart Surgery Database as Operation Type 1261

= ECMO; and 1262

5) Any operation classified by the STS Congenital Heart 1263

Surgery Database as an Operation Type other than CPB 1264

(CPB = Cardio Pulmonary = By-Pass) or No CPB 1265

Cardiovascular. 1266

ii) To further clarify surgical volume for the purposes of CMS volume 1267

requirements, surgical volume should be calculated based on each 1268

cardiac surgical admission that involves a cardiac surgical 1269

operation. For example, if patient A comes to the facility and has a 1270


August 2014

69

cardiac operation and then has a second cardiac operation later but 1271

during the same admission, that would be counted as one surgery. 1272

As another example, if patient B has multiple component 1273

procedures performed during the same cardiac operation, that 1274

would also be counted as one operation. Such guidelines are 1275

identical to the rules used by The Society of Thoracic Surgeons 1276

Database to calculate programmatic volume using index cardiac 1277

operations. CMS utilizes such national standards whenever 1278

available. 1279

i. 1280

4. If the facility volume is below 150, the facility shall be placed on 1281

probationary status for one (1) year. Probationary status may be extended 1282

one (1) additional year if the facility documents a positive trend in meeting 1283

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 CMS 1286

Pediatric Cardiovascular Center and the Department of Health. After a 90 1287

day transition period, the facility will receive a formal notice to end the 1288


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70

agreement between the CMS Pediatric Cardiovascular Center and the 1289

Department of Health. 1290

5. Facility Criteria: include all standards, other than facility volume 1291

standards, in the CMS Pediatric Cardiovascular Surgery Program 1292

Component section. 1293

If the facility is not in compliance with all the required criteria other than 1294

the volume standards, the facility must submit a corrective action plan for 1295

approval by the Deputy State Health Officer for CMS or designee upon 1296

the recommendation of the CMS Cardiac Technical Advisory Panel. If the 1297

plan is approved, the facility shall be granted one-year probationary status. 1298

Probationary status may be extended one (1) additional year if the facility 1299

documents improvements toward achieving all the facility criteria. If the 1300

facility is not in compliance with all the facility criteria at the end of a 1301

second year of probationary status, the facility shall be provided with a 1302

notice of intent to end the agreement between that CMS Pediatric 1303

Cardiovascular Center and the Department of Health the facility as a CMS 1304

Pediatric Cardiovascular Center. After a 90 day transition period, the 1305

facility will receive a formal notice to end the agreement between that 1306

CMS Pediatric Cardiovascular Center and the Department of Health 1307


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71

6. All CMS Pediatric Cardiovascular Centers must collect and submit the 1308

following quality assurance data to STS: 1309

Number of patients/ operations submitted and an analysis, discharge 1310

mortality, and complexity information, by year 1311

Aristotle Basic Complexity Level Discharge Mortality, by year 1312

RACHS-1 Discharge Mortality, by year 1313

Number of patients/operations in analysis, discharge mortality, and 1314

complexity information, by age group 1315

Aristotle Basic Complexity Level Discharge Mortality, by age group 1316

RACHS-1 Discharge Mortality, by age group 1317

Primary procedure outcomes, by anomaly 1318

STS-EACTS Mortality Category Discharge Mortality, by year 1319

STS-EACTS Mortality Category Discharge Mortality, by age group 1320

1321

7. Collect and submit quality assurance data annually in accordance with 1322

following CMS form: 1323

Patients with Fetal Diagnosis of Heart Conditions (DH-CMS 2065, 1324

10/20XX) 1325

1326


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72


the facility or CMS, a 90 day notice shall be provided to that CMS Pediatric 1328

Cardiovascular Center. 1329

9. The CMS Deputy State Health Officer for CMS or designee considers 1330

existing facilities for continued involvement upon the recommendation of the 1331

CMS Cardiac Technical Advisory Panel and fulfillment of all the criteria 1332

established above. The Deputy State Health Officer for CMS or designee 1333

shall make the final decision as to whether or not to continue such an 1334

agreement with the Department of Health. 1335

1336

pediatric cardiovascular center standards

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