1 california code of regulations title 22. social security ... · chapter 7.1 st-elevation...

Public Comment April 6, 2018 through May 21, 2018

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California Code of Regulations 1 Title 22. Social Security 2

Division 9. Prehospital Emergency Medical Services 3 Chapter 7.1 ST-Elevation Myocardial Infarction Critical Care System 4

5 6 ARTICLE 1. DEFINITIONS 7 8 § 100270.101. Cardiac Catheterization Laboratory 9 “Cardiac catheterization laboratory” or “Cath lab” means the setting within the hospital 10 where laboratory procedures for obtaining physiologic, pathologic, and angiographic 11 data can be performed on patients with cardiovascular disease. 12 13 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 14 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 15 16 § 100270.102. Cardiac Catheterization Team 17 “Cardiac catheterization team” means the specially trained medical staff that performs 18 percutaneous coronary intervention. It may include, but is not limited to, an 19 interventional cardiologist, mid-level practitioners, registered nurses, technicians, and 20 other health care professionals. 21 22 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 23 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 24 25 § 100270.103. Clinical Staff 26 “Clinical staff” means an individual that has specific training and experience in the 27 treatment and management of ST-Elevation Myocardial Infarction (STEMI) patients. 28 This includes, but is not limited to, physicians, registered nurses, advanced practice 29 nurses, physician assistants, pharmacists, and technologists. 30 31 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 32 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 33 34 § 100270.104. Door-to-Balloon Time 35 “Door-to-balloon time” or “D2B time” or “door-to-device time” means the amount of time 36 between a STEMI patient’s arrival at the hospital to the time he/she receives 37 percutaneous coronary intervention. 38 39 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 40 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 41 42


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§ 100270.105. Door-to-Needle Time 43 “Door-to-needle time” means the time interval between the arrival of a STEMI patient at 44 a hospital to the time fibrinolytic therapy is administered to open a blocked artery. 45 46 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 47 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 48 49 § 100270.106. Emergency Medical Services Authority 50 “Emergency medical services authority” or “EMS Authority” or “EMSA” means the 51 department in California responsible for the coordination and integration of all state 52 activities concerning EMS. 53 54 Note: Authority cited: Sections 1797.1, 1797.107 and 1797.54, Health and Safety Code. 55 Reference: Sections 1797.100, and 1797.103, Health and Safety Code. 56 57 § 100270.107. Immediately Available 58 “Immediately available” means 59 (a) Unencumbered by conflicting duties or responsibilities. 60 (b) Responding without delay upon receiving notification. 61 (c) Being physically available to the specified area of the hospital when the patient is 62 delivered in accordance with local EMS agency policies and procedures. 63 64 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 65 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 66 67 § 100270.108. Implementation 68 “Implementation,” “implemented” or “has implemented” means the development and 69 activation of a STEMI Critical Care System Plan by the local EMS agency, including the 70 prehospital and hospital care components in accordance with the plan. 71 72 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 73 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 74 75 § 100270.109. Interfacility Transfer 76 “Interfacility transfer” means the transfer of a STEMI patient from one acute general 77 care facility to another acute general care facility. 78 79 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 80 Reference: Sections 1797.103, 1797.176 and 1798.170, Health and Safety Code. 81 82 § 100270.110. Local Emergency Medical Services Agency 83


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“Local emergency medical services agency” or “local EMS agency” means the agency, 84 department, or office having primary responsibility for administration of emergency 85 medical services in a county and which is designated pursuant Health and Safety Code 86 commencing with section 1797.200. 87

88 Note: Authority cited: Sections 1797.107, 1797.200 and 1798.150, Health and Safety 89 Code. Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 90 91 § 100270.111. Percutaneous Coronary Intervention (PCI) 92 “Percutaneous coronary intervention” or “PCI” means a procedure used to open or 93 widen a narrowed or blocked coronary artery to restore blood flow supplying the heart. 94 A PCI is generally done on an emergency basis for a STEMI patient. 95 96 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 97 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 98 99 § 100270.112. Quality Improvement 100 “Quality improvement” or “QI” means methods of evaluation that are composed of 101 structure, process, and outcome evaluations that focus on improvement efforts to 102 identify root causes of problems, intervene to reduce or eliminate these causes, and 103 take steps to correct the process, and recognize excellence in performance and delivery 104 of care. 105 106 Note: Authority cited: Sections 1797.103, 1797.107, 1797.174, 1797.176 and 1798.150 107 Health and Safety Code. Reference: Sections 1797.174, 1797.202, 1797.204, 1797.220 108 and 1798.175, Health and Safety Code. 109 110 § 100270.113. ST-Elevation Myocardial Infarction (STEMI) 111 “ST-Elevation Myocardial Infarction” or “STEMI” means a clinical syndrome defined by 112 characteristic symptoms of myocardial infarction in association with ST-segment 113 elevation on ECG. 114 115 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 116 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 117 118 § 100270.114. STEMI Care 119 “STEMI care” means emergency cardiac care, for the purposes of these regulations. 120 121 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 122 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 123 124 § 100270.115. STEMI Medical Director 125


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“STEMI medical director” means a qualified physician as defined by the local EMS 126 agency and designated by the hospital that is responsible for the STEMI program, 127 performance improvement, and patient safety programs related to a STEMI critical care 128 system. 129

130 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 131 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 132 133 § 100270.116. STEMI Patient 134 “STEMI patient” means a patient with characteristic symptoms of myocardial infarction 135 in association with ST-Segment Elevation in an Electrocardiogram (ECG). 136 137 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 138 Reference: Sections 1797.103, 1797.176 and 1797.220, Health and Safety Code. 139 140 § 100270.117. STEMI Program 141 “STEMI program” means an organizational component of the hospital specializing in the 142 care of STEMI patients. 143 144 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 145 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 146 147 § 100270.118. STEMI Program Manager 148 “STEMI program manager” means a registered nurse or qualified individual as defined 149 by the local EMS agency, and designated by the hospital responsible for monitoring and 150 evaluating STEMI patients, performance improvement, and patient safety programs 151 related to a STEMI critical care system. 152 153 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 154 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 155 156 § 100270.119. STEMI Receiving Center (SRC) 157 “STEMI receiving center” or “SRC” means a licensed general acute care facility that 158 meets the minimum hospital STEMI care requirements pursuant to Section 100270.127 159 and is able to perform primary PCI. 160 161 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 162 Reference: Sections 1797.103, 1797.176 and 1797.220, Health and Safety Code. 163 164 § 100270.120. STEMI Referring Hospital (SRH) 165 “STEMI referring hospital” means a licensed general acute care facility that meets the 166 minimum hospital STEMI care requirements pursuant to Section 100270.128. 167


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168 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 169 Reference: Sections 1797.103, 1797.176 and 1797.220, Health and Safety Code. 170 171 § 100270.121. STEMI Technical Advisory Committee 172 “STEMI technical advisory committee” means a multidisciplinary committee as 173 appointed by the EMS Authority. The STEMI Technical Advisory Committee serves as 174 an advisory committee to the EMS Authority on STEMI related issues. 175 176 Note: Authority cited: Sections 1797.107, 1797.133 and 1798.150, Health and Safety 177 Code. Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 178 179 § 100270.122. STEMI Critical Care System 180 “STEMI critical care system” means a critical care component of the EMS system 181 developed by a local EMS agency. This system of care links prehospital and hospital 182 care to deliver treatment to STEMI patients. 183 184 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 185 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 186 187 § 100270.123. STEMI Team 188 “STEMI team” means clinical personnel, support personnel, and administrative staff that 189 function together as part of the hospital’s STEMI program. 190 191 Note: Authority cited: Sections 1797.107 and 1798.150, Health and Safety Code. 192 Reference: Sections 1797.103 and 1797.176, Health and Safety Code. 193 194 ARTICLE 2. LOCAL EMS AGENCY STEMI CRITICAL CARE SYSTEM 195 REQUIREMENTS 196 197 § 100270.124. STEMI Critical Care System Plan 198

199 (a) The local EMS agency may develop and implement a STEMI critical care system. 200

201 (b) The local EMS agency implementing a STEMI Critical Care System Plan shall have 202 a STEMI critical care system approved by the EMS Authority before implementation. 203

204 (c) A STEMI Critical Care System Plan submitted to the EMS Authority shall include, 205 at a minimum, all the following components: 206 207 (1) The names and titles of the local EMS agency personnel who have a role in a 208 STEMI critical care system. 209


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210 (2) Verification of agreements with hospitals for designation of STEMI facilities with the 211 list of STEMI hospital contracts and contract expiration dates. 212 213 (3) A description or a copy of the local EMS agency’s STEMI patient identification and 214 destination policies. 215 216 (4) A description or a copy of the method of field communication to the receiving 217 hospital specific to STEMI patient, designed to expedite time-sensitive treatment on 218 arrival. 219 220 (5) A description or a copy of the policy that facilitates the inter-facility transfer of a 221 STEMI patient. 222 223 (6) A description of the method of data collection from the EMS providers and 224 designated STEMI hospitals to the local EMS agency and the EMS Authority. 225 226 (7) A copy of all written agreements with neighboring local EMS agencies that provide 227 STEMI care. 228 229 (8) A description of the integration of STEMI into an existing quality improvement 230 committee or a description of any STEMI specific quality improvement committee. 231 232 (9) A description of programs to conduct or promote public education specific to cardiac 233 care. 234 235 (d) The EMS Authority shall, within 30 days of receiving a request for approval, notify 236 the requesting local EMS agency in writing of approval or disapproval of its STEMI 237 Critical Care System Plan. If the STEMI Critical Care System Plan is disapproved, the 238 response shall include the reason(s) for the disapproval and any required corrective 239 action items. 240 241 (e) The local EMS agency shall provide a corrected plan to the EMS Authority within 60 242 days of receipt of the disapproval letter. 243 244 (f) The local EMS agency currently operating a STEMI critical care system implemented 245 before the effective date of these regulations, shall submit to the EMS Authority a 246 STEMI Critical Care System Plan as an addendum to its next annual EMS plan update, 247 or within 180 days of the effective date of these regulations, whichever comes first. 248 249


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(g) After approval of the STEMI Critical Care System Plan, the local EMS agency shall 250 submit an update to the plan as part of its annual EMS update, consistent with the 251 requirements in Section 100270.125. 252 253 (h) No health care facility shall advertise in any manner or otherwise hold itself out to be 254 affiliated with a STEMI critical care system or a STEMI center unless they have been so 255 designated by the local EMS agency, in accordance with this Chapter. 256 257 Note: Authority cited: Sections 1797.107, 1797.103, 1797.105, 1797.250, 1797.254 and 258 1798.150, Health and Safety Code. Reference: Section 1797.176 and 1797.220, Health 259 and Safety Code. 260 261 §100270.125. STEMI Critical Care System Plan Updates 262 263 (a) The local EMS agency shall submit an annual update of its STEMI Critical Care 264 System Plan, as part of its annual EMS plan submittal, which shall include, at a 265 minimum, all the following: 266 267 (1) Any changes in a STEMI critical care system since submission of the prior annual 268 plan update or a STEMI Critical Care System Plan addendum. 269 270 (2) The status of a STEMI critical care system goals and objectives. 271 272 (3) The STEMI critical care system quality improvement activities. 273 274 (4) The progress on addressing action items and recommendations provided by the 275 EMS Authority within the STEMI Critical Care System Plan or status report approval 276 letter if applicable. 277 278 Note: Authority cited: Sections 1797.103, 1797.107, 1797.176, 1797.250, 1797.254, 279 1798.150, and 1798.172, Health and Safety Code. Reference: Section 1797.176, 280 1797.220, 1797.222, 1798.170, Health and Safety Code. 281 282 ARTICLE 3. PREHOSPITAL STEMI CRITICAL CARE SYSTEM REQUIREMENTS 283 284 § 100270.126. EMS Personnel and Early Recognition 285 286 (a) The local EMS agency with an established STEMI critical care system shall have 287 protocols for the treatment of STEMI patients, including paramedic capability to perform 288 a 12-lead ECG, to determine the patient destination. 289 290


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(b) When 12-lead ECG equipment is used, those findings shall be assessed and 291 interpreted through one or more of the following methods: 292 293 (1) Direct paramedic interpretation. 294 295 (2) Automated computer algorithm. 296 297 (3) Wireless transmission to facility followed by physician interpretation or confirmation. 298 299 (c) Advance notification of prehospital ECG findings of suspected STEMI patients, as 300 defined by the local EMS agency, will be communicated to the STEMI facilities, centers 301 or hospitals according to the local EMS agency’s STEMI Critical Care System Plan. 302 303 Note: Authority cited: Sections 1797.103, 1797.107, 1797.114, 1797.176, 1797.206, 304 1797.214 and 1798.150, Health and Safety Code. Reference: Section 1797.176, 305 1797.220, 1798, 1798.150 and 1798.170, Health and Safety Code. 306 307 ARTICLE 4. STEMI CRITICAL CARE FACILITY REQUIREMENTS 308 309 § 100270.127. STEMI Receiving Center Requirements 310 311 (a) The following minimum criteria shall be used by the local EMS agency for the 312 designation of a STEMI receiving center: 313 314 (1) The hospital shall have established protocols for triage, diagnosis, and Cath lab 315 activation from field notification. 316 317 (2) The hospital shall have a single call activation system to activate the Cath lab team 318 directly. 319 320 (3) Written protocols shall be in place for the identification of STEMI patients. 321 322 (A) At a minimum, these written protocols shall be available in the intensive care 323 unit/coronary care unit and the emergency department. 324 325 (4) The hospital shall be available for treatment of STEMI patients twenty-four (24) 326 hours per day, seven (7) days per week, three hundred and sixty-five (365) days per 327 year. 328 329 (5) The hospital shall have a process in place for the treatment and triage of 330 simultaneously arriving STEMI patients. 331 332


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(6) The hospital shall maintain a STEMI team call roster. 333 334 (7) The Cath lab team, including appropriate staff determined by the local EMS agency, 335 shall be immediately available. 336 337 (8) The hospital shall agree to accept all STEMI patients according to the local policy. 338 339 (9) STEMI receiving centers shall comply with the requirement for a minimum volume of 340 procedures for designation by the local EMS agency. 341 342 (10) The hospital shall have a STEMI program manager and a STEMI medical director. 343 344 (11) The hospital shall have job descriptions and organizational charts depicting the 345 relationship between the STEMI medical director, STEMI program manager, and the 346 STEMI team. 347 348 (12) The hospital shall participate in the local EMS agency quality improvement 349 processes related to a STEMI critical care system. 350 351 (13) A STEMI receiving center without cardiac surgery capability on-site shall have a 352 written transfer plan and agreements for transfer to a facility with cardiovascular surgery 353 capability. 354 355 (14) A STEMI receiving center shall have on-site accreditation reviews conducted every 356 three years. 357 358 (b) A STEMI center designated by the local EMS agency prior to implementation of 359 these regulations may continue to operate. Before re-designation by the local EMS 360 agency at the next regular interval, STEMI centers shall be re-evaluated to meet the 361 criteria established in these regulations. 362 363 (c) Additional requirements may be included at the discretion of the local EMS agency 364 medical director. 365 366 Note: Authority cited: Sections 1797.103, 1797.107, 1797.176, 1797.220, and 1798.150 367 1798.167 and 1798.172, Health and Safety Code. Reference: Section 1797.176, 368 1797.220, 1798, 1798.150 and 1798.170 Health and Safety Code. 369 370 § 100270.128. STEMI Referring Hospital Requirements 371 372 (a) The following minimum criteria shall be used by the local EMS agency for 373 designation of a STEMI referring hospital: 374


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375 (1) The hospital shall be committed to supporting and sustaining the STEMI Program. 376 377 (2) The hospital shall be available to provide care for STEMI patients twenty-four (24) 378 hours per day, seven (7) days per week, Three hundred and sixty-five (365) days per 379 year. 380 381 (3) Written protocols shall be in place for the identification of STEMI patients. 382 383 (A) At a minimum, these written protocols shall be available in the intensive care 384 unit/coronary care unit and the emergency department. 385 386 (4) The emergency department shall maintain a standardized procedure for the 387 treatment of STEMI patients. 388 389 (5) The hospital shall have a transfer process through interfacility transfer agreements, 390 and have pre-arranged agreements with EMS providers for a higher level of care and 391 rapid transport of STEMI patients to an SRC when considering ground or air transport. 392 393 (6) The hospital shall have a program to track and improve treatment. 394 395 (7) The hospital must have a plan to work with a STEMI referring hospital and the local 396 EMS agency on quality improvement processes. 397 398 (8) A STEMI referring hospital shall have on-site accreditation reviews conducted every 399 three years. 400 401 (b) A STEMI center designated by the local EMS agency prior to implementation of 402 these regulations may continue to operate. Before re-designation by the local EMS 403 agency at the next regular interval, STEMI centers shall be re-evaluated to meet the 404 criteria established in these regulations. 405 406 (c) Additional requirements may be included at the discretion of the local EMS agency 407 medical director. 408 409 Note: Authority cited: Sections 1797.103, 1797.107, 1797.176, 1797.220, and 1798.150 410 1798.167 and 1798.172, Health and Safety Code. Reference: Section 1797.176, 411 1797.220, 1798.150 and 1798.170 Health and Safety Code. 412 413 ARTICLE 5. DATA MANAGEMENT, QUALITY IMPROVEMENT AND EVALUATIONS 414 415 § 100270.129. Data Management. 416


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417 (a) The local EMS agency shall implement a standardized data collection and reporting 418 process for a STEMI critical care system. 419 420 (b) The system shall include the collection of both prehospital and hospital patient care 421 data, as determined by the local EMS agency. 422 423 (c) The prehospital STEMI patient care elements selected by the local EMS agency 424 shall be compliant with the most current version of the California EMS Information 425 Systems (CEMSIS) database, and the National EMS Information System (NEMSIS). 426 427 (d) The hospital STEMI patient care data elements shall be compliant with the National 428 Cardiovascular Data Registry (NCDR), Data Collection Form Premier 2.4.2, dated April 429 10, 2017. 430 431 (e) All hospitals that receive STEMI patients shall participate in the local EMS agency 432 data collection process in accordance with local EMS agency policies and procedures. 433 434 (f) The patient care data elements shall be collected and submitted to the local EMS 435 agency by the hospital, and subsequently to the EMS Authority, on no less than a 436 quarterly basis and shall include, but not be limited to, the following: 437

438 (1) EMS ePCR Number. 439 (2) Facility. 440 (3) Name: Last, First. 441 (4) Date of Birth. 442 (5) Patient Age. 443 (6) Patient Gender. 444 (7) Patient Race. 445 (8) Hospital Arrival Date. 446 (9) Hospital Arrival Time. 447 (10) Dispatch Date. 448 (11) Dispatch Time. 449 (12) Field ECG Performed. 450 (13) 1st ECG Date. 451 (14) 1st ECG Time. 452 (15) Did the patient suffer out-of-hospital cardiac arrest. 453 (16) CATH LAB Activated. 454 (17) CATH LAB Activation Date. 455 (18) CATH LAB Activation Time. 456 (19) Did the patient go to the CATH LAB. 457 (20) CATH LAB Arrival Date. 458


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(21) CATH LAB Arrival Time. 459 (22) PCI Performed. 460 (23) PCI Date. 461 (24) PCI Time. 462 (25) Fibrinolytic Infusion. 463 (26) Fibrinolytic Infusion Date. 464 (27) Fibrinolytic Infusion Time. 465 (28) Transfer. 466 (29) SRH ED Arrival Date. 467 (30) SRH ED Arrival Time. 468 (31) SRH ED Departure Date. 469 (32) SRH ED Departure Time. 470 (33) Hospital Discharge Date. 471 (34) Patient Outcome. 472 (35) Discharge Diagnosis. 473 474 Note: Authority cited: Sections 1791.102, 1797.103, 1797.107, 1797.176, 1797.204, 475 1797.220, 1798.150, and 1798.172, Health and Safety Code. Reference: Section 476 1797.220, 1797.222, 1797.204, Health and Safety Code. 477 478 § 100270.130. Quality Improvement and Evaluation Process 479 480 (a) A STEMI critical care system shall have a quality improvement process to include 481 structure, process, and outcome evaluations which focus on improvement efforts to 482 identify root causes of problems, intervene to reduce or eliminate these causes, and 483 take steps to correct the process. This process shall include, at a minimum: 484 485 (1) A detailed audit of all STEMI-related deaths, major complications, and transfers. 486 487 (2) A multidisciplinary STEMI Quality Improvement Committee, including both 488 prehospital and hospital members. 489 490 (3) Compliance with the California Evidence Code, Section 1157.7 to ensure 491 confidentiality, and a disclosure-protected review of selected STEMI cases. 492 493 (b)The local EMS agency shall be responsible for the following: 494 495 (1) The on-going performance evaluation of a local or regional STEMI critical care 496 system. 497 498 (2) The development of a quality improvement process pursuant to this section. 499 500


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(3) Ensuring that designated STEMI centers, other hospitals that treat STEMI patients 501 and prehospital providers involved in a STEMI critical care system participate in the 502 quality improvement process contained in this section. 503 504 Note: Authority cited: Sections 1797.102, 1797.103, 1797.107, 1797.176, 1797.204, 505 1797.220, 1797.250, 1797.254, 1798.150, and 1798.172, Health and Safety Code. 506 Reference: Section 1797.104, 1797.176, 1797.204, 1797.220, 1797.222, 1798.170, 507 Health and Safety Code. 508

1 california code of regulations title 22. social security ... · chapter 7.1 st-elevation...

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