| 1 | A bill to be entitled |
| 2 | An act relating to patient safety; creating s. 381.0271, |
| 3 | F.S.; providing definitions; creating the Florida Patient |
| 4 | Safety Corporation; authorizing the corporation to create |
| 5 | not-for-profit corporate subsidiaries; specifying that the |
| 6 | corporation and certain subsidiaries are not government |
| 7 | agencies; requiring the corporation and certain |
| 8 | subsidiaries to be subject to public meetings and records |
| 9 | requirements; exempting the corporation and certain |
| 10 | subsidiaries from certain provisions relating to |
| 11 | procurement of personal property and services; providing a |
| 12 | purpose for the corporation; establishing the membership |
| 13 | of the board of directors of the corporation; requiring |
| 14 | certain advisory committees for the corporation; requiring |
| 15 | the Agency for Health Care Administration to provide |
| 16 | assistance in establishing the corporation; specifying the |
| 17 | powers and duties of the corporation; requiring annual |
| 18 | reports; requiring the corporation to seek private-sector |
| 19 | funding and apply for grants for certain purposes; |
| 20 | requiring the Office of Program Policy Analysis and |
| 21 | Government Accountability, the Agency for Health Care |
| 22 | Administration, and the Department of Health to develop |
| 23 | performance measures for the corporation; requiring a |
| 24 | performance audit; providing an effective date. |
| 25 |
|
| 26 | Be It Enacted by the Legislature of the State of Florida: |
| 27 |
|
| 28 | Section 1. Section 381.0271, Florida Statutes, is created |
| 29 | to read: |
| 30 | 381.0271 Florida Patient Safety Corporation.-- |
| 31 | (1) DEFINITIONS.--As used in this section, the term: |
| 32 | (a) "Adverse incident" has the meanings given to the term |
| 33 | in ss. 395.0197, 458.351, and 459.026. |
| 34 | (b) "Corporation" means the Florida Patient Safety |
| 35 | Corporation created in this section. |
| 36 | (c) "Patient safety data" has the meaning given to the |
| 37 | term in s. 766.1016. |
| 38 | (2) CREATION.-- |
| 39 | (a) There is created a not-for-profit corporation, to be |
| 40 | known as the Florida Patient Safety Corporation, which shall be |
| 41 | registered, incorporated, organized, and operated in compliance |
| 42 | with chapter 617. The corporation is authorized to create not- |
| 43 | for-profit corporate subsidiaries that are organized under the |
| 44 | provisions of chapter 617, upon the prior approval of the board |
| 45 | of directors, as necessary, to fulfill its mission. |
| 46 | (b) Neither the corporation nor any authorized and |
| 47 | approved subsidiary is an agency as defined in s. 20.03(11). |
| 48 | (c) The corporation and any authorized and approved |
| 49 | subsidiary are subject to the public meetings and records |
| 50 | requirements of s. 24, Art. I of the State Constitution, chapter |
| 51 | 119, and s. 286.011. |
| 52 | (d) The corporation and any authorized and approved |
| 53 | subsidiary are not subject to the provisions of chapter 287. |
| 54 | (e) The corporation is a patient safety organization as |
| 55 | defined in s. 766.1016. |
| 56 | (3) PURPOSE.-- |
| 57 | (a) The purpose of the Florida Patient Safety Corporation |
| 58 | is to serve as a learning organization dedicated to assisting |
| 59 | health care providers in the state to improve the quality and |
| 60 | safety of health care rendered and to reduce harm to patients. |
| 61 | The corporation shall promote the development of a culture of |
| 62 | patient safety in the health care system in the state. The |
| 63 | corporation shall not regulate health care providers in the |
| 64 | state. |
| 65 | (b) In the fulfillment of its purpose, the corporation |
| 66 | shall work with a consortium of patient safety centers within |
| 67 | the universities of the state and other patient safety centers |
| 68 | and programs. |
| 69 | (4) BOARD OF DIRECTORS; MEMBERSHIP.--The corporation shall |
| 70 | be governed by a board of directors. The board of directors |
| 71 | shall consist of: |
| 72 | (a) The chair of the Florida Council of Medical School |
| 73 | Deans. |
| 74 | (b) The person responsible for patient safety issues for |
| 75 | the authorized health insurer with the largest market share as |
| 76 | measured by premiums written in the state for the most recent |
| 77 | calendar year, appointed by such insurer. |
| 78 | (c) A representative of an authorized medical malpractice |
| 79 | insurer appointed by the insurers. |
| 80 | (d) The president of the Florida Health Care Coalition. |
| 81 | (e) A representative of a hospital in the state that is |
| 82 | implementing innovative patient safety initiatives, appointed by |
| 83 | the Florida Hospital Association. |
| 84 | (f) A physician with expertise in patient safety, |
| 85 | appointed by the Florida Medical Association. |
| 86 | (g) An osteopathic physician with expertise in patient |
| 87 | safety, appointed by the Florida Osteopathic Medical |
| 88 | Association. |
| 89 | (h) A podiatric physician with expertise in patient |
| 90 | safety, appointed by the Florida Podiatric Medical Association. |
| 91 | (i) A chiropractic physician with expertise in patient |
| 92 | safety, appointed by the Florida Chiropractic Association. |
| 93 | (j) A dentist with expertise in patient safety, appointed |
| 94 | by the Florida Dental Association. |
| 95 | (k) A nurse with expertise in patient safety, appointed by |
| 96 | the Florida Nurses Association. |
| 97 | (l) An institutional pharmacist, appointed by the Florida |
| 98 | Society of Health-System Pharmacists. |
| 99 | (m) A representative of Florida AARP, appointed by the |
| 100 | state director of Florida AARP. |
| 101 | (n) An independent consultant on health care information |
| 102 | systems, appointed jointly by the Central Florida Chapter and |
| 103 | the South Florida Chapter of the Healthcare Information and |
| 104 | Management Systems Society. |
| 105 | (5) ADVISORY COMMITTEES.--In addition to any committees |
| 106 | that the corporation may establish, the corporation shall |
| 107 | establish the following advisory committees: |
| 108 | (a) A scientific research advisory committee that |
| 109 | includes, at a minimum, a representative from each patient |
| 110 | safety center or other patient safety program in the |
| 111 | universities of the state. The duties of the scientific research |
| 112 | advisory committee shall include, but not be limited to, the |
| 113 | analysis of existing data and research to improve patient safety |
| 114 | and encourage evidence-based medicine. |
| 115 | (b) A technology advisory committee that includes, at a |
| 116 | minimum, a representative of a hospital that has implemented a |
| 117 | computerized physician order entry system and a health care |
| 118 | provider that has implemented an electronic medical records |
| 119 | system. The duties of the technology advisory committee shall |
| 120 | include, but not be limited to, implementation of new |
| 121 | technologies, including electronic medical records. |
| 122 | (c) A health care provider advisory committee that |
| 123 | includes, at a minimum, representatives of hospitals, ambulatory |
| 124 | surgical centers, physicians, nurses, and pharmacists licensed |
| 125 | in the state and a representative of the Veterans Integrated |
| 126 | Service Network 8. The duties of the health care provider |
| 127 | advisory committee shall include, but not be limited to, |
| 128 | promotion of a culture of patient safety that reduces errors. |
| 129 | (d) A health care consumer advisory committee that |
| 130 | includes, at a minimum, representatives of businesses that |
| 131 | provide health insurance coverage to their employees, consumer |
| 132 | advocacy groups, and representatives of patient safety |
| 133 | organizations. The duties of the health care consumer advisory |
| 134 | committee shall include, but not be limited to, identification |
| 135 | of incentives to encourage patient safety and the efficiency and |
| 136 | quality of care. |
| 137 | (e) A litigation alternatives advisory committee that |
| 138 | includes, at a minimum, representatives of medical malpractice |
| 139 | plaintiff's and defendant's attorneys and a representative of |
| 140 | each law school in the state. The duties of the litigation |
| 141 | alternatives advisory committee shall include, but not be |
| 142 | limited to, identification of alternative systems to compensate |
| 143 | for injuries. |
| 144 | (f) An education advisory committee that includes, at a |
| 145 | minimum, the associate dean for education, or the equivalent |
| 146 | position, as a representative from each school of medicine and |
| 147 | nursing to provide advice on the development, implementation, |
| 148 | and measurement of core competencies for patient safety to be |
| 149 | considered for incorporation in the educational programs of the |
| 150 | universities and colleges of the state. |
| 151 | (6) ORGANIZATION; MEETINGS.-- |
| 152 | (a) The Agency for Health Care Administration shall assist |
| 153 | the corporation in its organizational activities required under |
| 154 | chapter 617, including, but not limited to: |
| 155 | 1. Eliciting appointments for the initial board of |
| 156 | directors. |
| 157 | 2. Convening the first meeting of the board of directors |
| 158 | and assisting with other meetings of the board of directors, |
| 159 | upon request of the board of directors, during the first year of |
| 160 | operation of the corporation. |
| 161 | 3. Drafting articles of incorporation for the board of |
| 162 | directors and, upon request of the board of directors, |
| 163 | delivering articles of incorporation to the Department of State |
| 164 | for filing. |
| 165 | 4. Drafting proposed bylaws for the corporation. |
| 166 | 5. Paying fees related to incorporation. |
| 167 | 6. Providing office space and administrative support, at |
| 168 | the request of the board of directors, but not beyond July 1, |
| 169 | 2005. |
| 170 | (b) The board of directors must conduct its first meeting |
| 171 | no later than August 1, 2004, and shall meet thereafter as |
| 172 | frequently as necessary to carry out the duties of the |
| 173 | corporation. |
| 174 | (7) POWERS AND DUTIES.--In addition to the powers and |
| 175 | duties prescribed in chapter 617, and the articles and bylaws |
| 176 | adopted under that chapter, the corporation shall, either |
| 177 | directly or through contract: |
| 178 | (a) Secure staff necessary to properly administer the |
| 179 | corporation. |
| 180 | (b) Collect, analyze, and evaluate patient safety data, |
| 181 | quality and patient safety indicators, medical malpractice |
| 182 | closed claims, and adverse incidents reported to the Agency for |
| 183 | Health Care Administration and the Department of Health for the |
| 184 | purpose of recommending changes in practices and procedures that |
| 185 | may be implemented by health care practitioners and health care |
| 186 | facilities to improve health care quality and to prevent future |
| 187 | adverse incidents. Notwithstanding any other law, the Agency for |
| 188 | Health Care Administration and the Department of Health shall |
| 189 | make available to the corporation any adverse incident report |
| 190 | submitted under ss. 395.0197, 458.351, and 459.026. To the |
| 191 | extent that adverse incident reports submitted under s. 395.0197 |
| 192 | are confidential and exempt, the confidential and exempt status |
| 193 | of such reports must be maintained by the corporation. |
| 194 | (c) Establish a 3-year pilot project of a near-miss |
| 195 | patient safety reporting system. The purpose of this system is |
| 196 | to identify potential systemic problems that could lead to |
| 197 | adverse incidents, enable publication of system-wide alerts of |
| 198 | potential harm, and facilitate development of both facility- |
| 199 | specific and statewide options to avoid adverse incidents and |
| 200 | improve patient safety. The reporting system shall record near- |
| 201 | misses submitted by hospitals, birthing centers, ambulatory |
| 202 | surgical facilities, and other providers. For the purpose of the |
| 203 | reporting system: |
| 204 | 1. The term "near miss" means any potentially harmful |
| 205 | event that could have had an adverse result, but, through chance |
| 206 | or intervention, harm was prevented. |
| 207 | 2. The near-miss reporting system shall be voluntary, |
| 208 | anonymous, and independent of mandatory reporting systems used |
| 209 | for regulatory purposes. |
| 210 | 3. Data submitted to the corporation shall be de- |
| 211 | identified and shall not be discoverable or admissible in any |
| 212 | civil or administrative action. |
| 213 | 4. Reports of near-miss data shall be published on a |
| 214 | regular basis and special alerts shall be published as needed |
| 215 | regarding newly identified, significant risks. |
| 216 | 5. Aggregated near-miss data shall be made publicly |
| 217 | available. |
| 218 | 6. The corporation shall report the performance and |
| 219 | results of the reporting system pilot project in its annual |
| 220 | report. |
| 221 | (d) Foster the development of a statewide electronic |
| 222 | infrastructure, including implementation of statewide electronic |
| 223 | medical records systems, that may be implemented in phases over |
| 224 | a multiyear period and that is designed to improve patient care |
| 225 | and the delivery and quality of health care services by health |
| 226 | care facilities and health care practitioners. Support for |
| 227 | implementation of electronic medical records systems shall |
| 228 | include: |
| 229 | 1. A report to the Governor, the President of the Senate, |
| 230 | the Speaker of the House of Representatives, and the Agency for |
| 231 | Health Care Administration by January 1, 2005, identifying: |
| 232 | a. Public and private-sector initiatives relating to |
| 233 | electronic medical records and the communication systems used to |
| 234 | share clinical information among caregivers. |
| 235 | b. Regulatory barriers that interfere with the sharing of |
| 236 | clinical information among caregivers. |
| 237 | c. Investment incentives that might be used to promote the |
| 238 | use of recommended technologies by health care providers. |
| 239 | d. Educational strategies that may be implemented to |
| 240 | educate health care providers about the recommended technologies |
| 241 | for sharing clinical information. |
| 242 | 2. An implementation plan reported to the Governor, the |
| 243 | President of the Senate, the Speaker of the House of |
| 244 | Representatives, and the Agency for Health Care Administration |
| 245 | by September 1, 2005, that must include, but need not be limited |
| 246 | to, the capital investment required to begin implementing the |
| 247 | system, the costs of operating the system, the financial |
| 248 | incentives recommended to increase capital investment, data |
| 249 | concerning the providers initially committed to participating in |
| 250 | the system by region, the standards for systemic functionality |
| 251 | and features, any marketing plan to increase participation, and |
| 252 | implementation schedules for key components. |
| 253 | (e) Provide for access to an active library of evidence- |
| 254 | based medicine and patient safety practices, including the |
| 255 | emerging evidence supporting their retention or modification, |
| 256 | and make this information available to health care |
| 257 | practitioners, health care facilities, and the public. Support |
| 258 | for implementation of evidence-based medicine shall include: |
| 259 | 1. A report to the Governor, the President of the Senate, |
| 260 | the Speaker of the House of Representatives, and the Agency for |
| 261 | Health Care Administration by January 1, 2005, identifying: |
| 262 | a. The ability to join or support efforts for the use of |
| 263 | evidence-based medicine already underway, such as those of the |
| 264 | Leapfrog Group, the international group Bandolier, and the |
| 265 | Healthy Florida Foundation. |
| 266 | b. The means by which to promote research using Medicaid |
| 267 | and other data collected by the Agency for Health Care |
| 268 | Administration to identify and quantify the most cost-effective |
| 269 | treatment and interventions, including disease management and |
| 270 | prevention programs. |
| 271 | c. The means by which to encourage development of systems |
| 272 | to measure and reward providers who implement evidence-based |
| 273 | medical practices. |
| 274 | d. The review of other state and private initiatives and |
| 275 | published literature for promising approaches and the |
| 276 | dissemination of information about such initiatives and |
| 277 | literature to providers. |
| 278 | e. The encouragement of the state health care boards under |
| 279 | the Department of Health to regularly publish findings related |
| 280 | to the cost-effectiveness of disease-specific evidence-based |
| 281 | standards. |
| 282 | f. Public and private-sector initiatives related to |
| 283 | evidence-based medicine and communication systems for the |
| 284 | sharing of clinical information among caregivers. |
| 285 | g. Regulatory barriers that interfere with the sharing of |
| 286 | clinical information among caregivers. |
| 287 | 2. An implementation plan reported to the Governor, the |
| 288 | President of the Senate, the Speaker of the House of |
| 289 | Representatives, and the Agency for Health Care Administration |
| 290 | by September 1, 2005, that must include, but need not be limited |
| 291 | to, estimated costs and savings, capital investment |
| 292 | requirements, recommended investment incentives, initial |
| 293 | committed provider participation by region, standards of |
| 294 | functionality and features, a marketing plan, and implementation |
| 295 | schedules for key components. |
| 296 | (f) Develop and recommend core competencies in patient |
| 297 | safety that can be incorporated into the curriculums in schools |
| 298 | of medicine, nursing, and allied health in the state. |
| 299 | (g) Develop programs to educate the public about the role |
| 300 | of health care consumers in promoting patient safety. |
| 301 | (h) Provide recommendations for interagency coordination |
| 302 | of patient safety efforts in the state. |
| 303 | (8) ADDITIONAL POWERS.--In carrying out its powers and |
| 304 | duties, the corporation may also: |
| 305 | (a) Assess the patient safety culture at volunteering |
| 306 | hospitals and recommend methods to improve the working |
| 307 | environment related to patient safety at these hospitals. |
| 308 | (b) Inventory the information technology capabilities |
| 309 | related to patient safety of health care facilities and health |
| 310 | care practitioners and recommend a plan for expediting the |
| 311 | implementation of patient safety technologies statewide. |
| 312 | (c) Recommend continuing medical education regarding |
| 313 | patient safety to practicing health care practitioners. |
| 314 | (d) Study and facilitate the testing of litigation |
| 315 | alternative systems, including risk management, best practices, |
| 316 | and systems of compensating injured patients, as a means of |
| 317 | reducing and preventing medical errors and promoting patient |
| 318 | safety. |
| 319 | (9) ANNUAL REPORT.--By December 1, 2004, the corporation |
| 320 | shall prepare a report on the startup activities of the |
| 321 | corporation and any proposals for legislative action that are |
| 322 | needed for the corporation to fulfill its purposes under this |
| 323 | section. By December 1 of each year thereafter, the corporation |
| 324 | shall prepare a report for the preceding fiscal year. The |
| 325 | report, at a minimum, must include: |
| 326 | (a) A description of the activities of the corporation |
| 327 | under this section. |
| 328 | (b) Progress made in improving patient safety and reducing |
| 329 | medical errors. |
| 330 | (c) Policies and programs that have been implemented and |
| 331 | their outcomes. |
| 332 | (d) A compliance and financial audit of the accounts and |
| 333 | records of the corporation at the end of the preceding fiscal |
| 334 | year conducted by an independent certified public accountant. |
| 335 | (e) Recommendations for legislative action needed to |
| 336 | improve patient safety in the state. |
| 337 |
|
| 338 | The corporation shall submit the report to the Governor, the |
| 339 | President of the Senate, and the Speaker of the House of |
| 340 | Representatives. |
| 341 | (10) PRIVATE-SECTOR FUNDING AND GRANTS.--The corporation |
| 342 | is required to seek private-sector funding and apply for grants |
| 343 | to accomplish its goals and duties. |
| 344 | (11) PERFORMANCE EXPECTATIONS.--The Office of Program |
| 345 | Policy Analysis and Government Accountability, the Agency for |
| 346 | Health Care Administration, and the Department of Health shall |
| 347 | develop performance standards by which to measure the success of |
| 348 | the corporation in fulfilling the purposes established in this |
| 349 | section. Using the performance standards, the Office of Program |
| 350 | Policy Analysis and Government Accountability shall conduct a |
| 351 | performance audit of the corporation during 2006 and shall |
| 352 | submit a report to the Governor, the President of the Senate, |
| 353 | and the Speaker of the House of Representatives by January 1, |
| 354 | 2007. |
| 355 | Section 2. This act shall take effect July 1, 2004. |