| 1 | A bill to be entitled |
| 2 | An act relating to medical quality assurance; amending s. |
| 3 | 395.0193, F.S.; requiring certain disciplinary actions to |
| 4 | be reported to the Division of Medical Quality Assurance |
| 5 | of the Department of Health instead of the Division of |
| 6 | Health Quality Assurance of the Agency for Health Care |
| 7 | Administration; amending s. 395.0197, F.S.; expanding the |
| 8 | list of health care practitioners to be reviewed by the |
| 9 | agency; requiring forwarding of incident reports to the |
| 10 | Division of Medical Quality Assurance of the Department of |
| 11 | Health for determination of need for disciplinary action |
| 12 | rather than the agency making such determination; |
| 13 | providing that certain annual reports are not required to |
| 14 | be forwarded to the department; amending s. 395.3025, |
| 15 | F.S.; transferring from the agency to the department |
| 16 | authority to access confidential patient records upon |
| 17 | issuance of a subpoena for the purpose of investigation, |
| 18 | prosecution, and appeal of disciplinary proceedings |
| 19 | relating to health care professionals; providing for a fee |
| 20 | for copies of records to be determined by rule of the |
| 21 | department; amending s. 400.147, F.S.; transferring from |
| 22 | the agency to the department certain duties relating to |
| 23 | disciplinary proceedings within the purview of the |
| 24 | department and appropriate regulatory boards; requiring a |
| 25 | copy of certain reports to be submitted to the Division of |
| 26 | Medical Quality Assurance of the department; amending ss. |
| 27 | 458.309 and 459.005, F.S.; providing that the department |
| 28 | shall inspect a physician's office unless such office is |
| 29 | accredited by a nationally recognized accrediting agency; |
| 30 | providing an effective date. |
| 31 |
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| 32 | Be It Enacted by the Legislature of the State of Florida: |
| 33 |
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| 34 | Section 1. Subsection (4) of section 395.0193, Florida |
| 35 | Statutes, is amended to read: |
| 36 | 395.0193 Licensed facilities; peer review; disciplinary |
| 37 | powers; agency or partnership with physicians.-- |
| 38 | (4) Pursuant to ss. 458.337 and 459.016, any disciplinary |
| 39 | actions taken under subsection (3) shall be reported in writing |
| 40 | to the Division of Medical Health Quality Assurance of the |
| 41 | department agency within 30 working days after its initial |
| 42 | occurrence, regardless of the pendency of appeals to the |
| 43 | governing board of the hospital. The notification shall identify |
| 44 | the disciplined practitioner, the action taken, and the reason |
| 45 | for such action. All final disciplinary actions taken under |
| 46 | subsection (3), if different from those which were reported to |
| 47 | the division agency within 30 days after the initial occurrence, |
| 48 | shall be reported within 10 working days to the division of |
| 49 | Health Quality Assurance of the agency in writing and shall |
| 50 | specify the disciplinary action taken and the specific grounds |
| 51 | therefor. The division shall review each report and determine |
| 52 | whether it potentially involved conduct by the licensee that is |
| 53 | subject to disciplinary action, in which case s. 456.073 shall |
| 54 | apply. The reports are not subject to inspection under s. |
| 55 | 119.07(1) even if the division's investigation results in a |
| 56 | finding of probable cause. |
| 57 | Section 2. Paragraphs (b) and (c) of subsection (6) and |
| 58 | subsections (7) and (13) of section 395.0197, Florida Statutes, |
| 59 | are amended to read: |
| 60 | 395.0197 Internal risk management program.-- |
| 61 | (6) |
| 62 | (b) The information reported to the agency pursuant to |
| 63 | paragraph (a) which relates to health care practitioners as |
| 64 | defined in s. 456.001(4) persons licensed under chapter 458, |
| 65 | chapter 459, chapter 461, or chapter 466 shall be reviewed by |
| 66 | the agency. The agency shall forward a copy of the report of |
| 67 | each incident to the Division of Medical Quality Assurance of |
| 68 | the department to determine whether it any of the incidents |
| 69 | potentially involved conduct by a health care professional who |
| 70 | is subject to disciplinary action, in which case the provisions |
| 71 | of s. 456.073 shall apply. The Agency for Health Care |
| 72 | Administration is not required to forward its annual reports to |
| 73 | the Department of Health. |
| 74 | (c) The report submitted to the agency shall also contain |
| 75 | the name and license number of the risk manager of the licensed |
| 76 | facility, a copy of its policy and procedures which govern the |
| 77 | measures taken by the facility and its risk manager to reduce |
| 78 | the risk of injuries and adverse incidents, and the results of |
| 79 | such measures. The annual report is confidential and is not |
| 80 | available to the public pursuant to s. 119.07(1) or any other |
| 81 | law providing access to public records. The annual report is not |
| 82 | discoverable or admissible in any civil or administrative |
| 83 | action, except in disciplinary proceedings by the agency or the |
| 84 | appropriate regulatory board. The annual report is not available |
| 85 | to the public as part of the record of investigation for and |
| 86 | prosecution in disciplinary proceedings made available to the |
| 87 | public by the agency or the appropriate regulatory board. |
| 88 | However, the agency or the appropriate regulatory board shall |
| 89 | make available, upon written request by a health care |
| 90 | professional against whom probable cause has been found, any |
| 91 | such records which form the basis of the determination of |
| 92 | probable cause. |
| 93 | (7) Any of the following adverse incidents, whether |
| 94 | occurring in the licensed facility or arising from health care |
| 95 | prior to admission in the licensed facility, shall be reported |
| 96 | by the facility to the agency within 15 calendar days after its |
| 97 | occurrence: |
| 98 | (a) The death of a patient; |
| 99 | (b) Brain or spinal damage to a patient; |
| 100 | (c) The performance of a surgical procedure on the wrong |
| 101 | patient; |
| 102 | (d) The performance of a wrong-site surgical procedure; |
| 103 | (e) The performance of a wrong surgical procedure; |
| 104 | (f) The performance of a surgical procedure that is |
| 105 | medically unnecessary or otherwise unrelated to the patient's |
| 106 | diagnosis or medical condition; |
| 107 | (g) The surgical repair of damage resulting to a patient |
| 108 | from a planned surgical procedure, where the damage is not a |
| 109 | recognized specific risk, as disclosed to the patient and |
| 110 | documented through the informed-consent process; or |
| 111 | (h) The performance of procedures to remove unplanned |
| 112 | foreign objects remaining from a surgical procedure. |
| 113 |
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| 114 | The agency may grant extensions to this reporting requirement |
| 115 | for more than 15 days upon justification submitted in writing by |
| 116 | the facility administrator to the agency. The agency may require |
| 117 | an additional, final report. These reports shall not be |
| 118 | available to the public pursuant to s. 119.07(1) or any other |
| 119 | law providing access to public records, nor be discoverable or |
| 120 | admissible in any civil or administrative action, except in |
| 121 | disciplinary proceedings by the agency or the appropriate |
| 122 | regulatory board, nor shall they be available to the public as |
| 123 | part of the record of investigation for and prosecution in |
| 124 | disciplinary proceedings made available to the public by the |
| 125 | agency or the appropriate regulatory board. However, the agency |
| 126 | or the appropriate regulatory board shall make available, upon |
| 127 | written request by a health care professional against whom |
| 128 | probable cause has been found, any such records which form the |
| 129 | basis of the determination of probable cause. The agency may |
| 130 | investigate, as it deems appropriate, any such incident and |
| 131 | prescribe measures that must or may be taken in response to the |
| 132 | incident. The agency shall forward a copy of each incident |
| 133 | report to the Department of Health, which shall determine |
| 134 | whether it potentially involved conduct by a health care |
| 135 | professional who is subject to disciplinary action, in which |
| 136 | case the provisions of s. 456.073 shall apply. The agency shall |
| 137 | review each incident and determine whether it potentially |
| 138 | involved conduct by the health care professional who is subject |
| 139 | to disciplinary action, in which case the provisions of s. |
| 140 | 456.073 shall apply. |
| 141 | (13) The agency shall have access to all licensed facility |
| 142 | records necessary to carry out the provisions of this section. |
| 143 | The records obtained by the agency under subsection (6), |
| 144 | subsection (7), or subsection (9) are not available to the |
| 145 | public under s. 119.07(1), nor shall they be discoverable or |
| 146 | admissible in any civil or administrative action, except in |
| 147 | disciplinary proceedings by the agency or the appropriate |
| 148 | regulatory board, nor shall records obtained pursuant to s. |
| 149 | 456.071 be available to the public as part of the record of |
| 150 | investigation for and prosecution in disciplinary proceedings |
| 151 | made available to the public by the agency or the appropriate |
| 152 | regulatory board. However, the agency or the appropriate |
| 153 | regulatory board shall make available, upon written request by a |
| 154 | health care professional against whom probable cause has been |
| 155 | found, any such records which form the basis of the |
| 156 | determination of probable cause, except that, with respect to |
| 157 | medical review committee records, s. 766.101 controls. |
| 158 | Section 3. Paragraph (e) of subsection (4) of section |
| 159 | 395.3025, Florida Statutes, is amended to read: |
| 160 | 395.3025 Patient and personnel records; copies; |
| 161 | examination.-- |
| 162 | (4) Patient records are confidential and must not be |
| 163 | disclosed without the consent of the person to whom they |
| 164 | pertain, but appropriate disclosure may be made without such |
| 165 | consent to: |
| 166 | (e) The department agency upon subpoena issued pursuant to |
| 167 | s. 456.071, but the records obtained thereby must be used solely |
| 168 | for the purpose of the department agency and the appropriate |
| 169 | professional board in its investigation, prosecution, and appeal |
| 170 | of disciplinary proceedings. If the department agency requests |
| 171 | copies of the records, the facility shall charge a reasonable |
| 172 | fee as determined by rule of the department no more than its |
| 173 | actual copying costs, including reasonable staff time. The |
| 174 | records must be sealed and must not be available to the public |
| 175 | pursuant to s. 119.07(1) or any other statute providing access |
| 176 | to records, nor may they be available to the public as part of |
| 177 | the record of investigation for and prosecution in disciplinary |
| 178 | proceedings made available to the public by the department |
| 179 | agency or the appropriate regulatory board. However, the |
| 180 | department agency must make available, upon written request by a |
| 181 | practitioner against whom probable cause has been found, any |
| 182 | such records that form the basis of the determination of |
| 183 | probable cause. |
| 184 | Section 4. Subsection (7) and paragraph (b) of subsection |
| 185 | (8) of section 400.147, Florida Statutes, are amended to read: |
| 186 | 400.147 Internal risk management and quality assurance |
| 187 | program.-- |
| 188 | (7) The facility shall initiate an investigation and shall |
| 189 | notify the agency within 1 business day after the risk manager |
| 190 | or his or her designee has received a report pursuant to |
| 191 | paragraph (1)(d). The notification must be made in writing and |
| 192 | be provided electronically, by facsimile device or overnight |
| 193 | mail delivery. The notification must include information |
| 194 | regarding the identity of the affected resident, the type of |
| 195 | adverse incident, the initiation of an investigation by the |
| 196 | facility, and whether the events causing or resulting in the |
| 197 | adverse incident represent a potential risk to any other |
| 198 | resident. The notification is confidential as provided by law |
| 199 | and is not discoverable or admissible in any civil or |
| 200 | administrative action, except in disciplinary proceedings by the |
| 201 | Department of Health agency or the appropriate regulatory board. |
| 202 | The agency may investigate, as it deems appropriate, any such |
| 203 | incident and prescribe measures that must or may be taken in |
| 204 | response to the incident. The Department of Health agency shall |
| 205 | review each incident and determine whether it potentially |
| 206 | involved conduct by the health care professional who is subject |
| 207 | to disciplinary action, in which case the provisions of s. |
| 208 | 456.073 shall apply. |
| 209 | (8) |
| 210 | (b) A copy of the report submitted The information |
| 211 | reported to the agency pursuant to paragraph (a) which relates |
| 212 | to health care practitioners as defined in s. 456.001(4) persons |
| 213 | licensed under chapter 458, chapter 459, chapter 461, or chapter |
| 214 | 466 shall be forwarded to the Division of Medical Quality |
| 215 | Assurance of the Department of Health for review reviewed by the |
| 216 | agency. The Department of Health agency shall determine whether |
| 217 | any of the incidents potentially involved conduct by a health |
| 218 | care professional who is subject to disciplinary action, in |
| 219 | which case the provisions of s. 456.073 shall apply. |
| 220 | Section 5. Subsection (3) of section 458.309, Florida |
| 221 | Statutes, is amended to read: |
| 222 | 458.309 Rulemaking authority.-- |
| 223 | (3) All physicians who perform level 2 procedures lasting |
| 224 | more than 5 minutes and all level 3 surgical procedures in an |
| 225 | office setting must register the office with the department |
| 226 | unless that office is licensed as a facility pursuant to chapter |
| 227 | 395. The department shall inspect the physician's office |
| 228 | annually unless the office is accredited by a nationally |
| 229 | recognized accrediting agency or an accrediting organization |
| 230 | subsequently approved by the Board of Medicine. The actual costs |
| 231 | for registration and inspection or accreditation shall be paid |
| 232 | by the person seeking to register and operate the office setting |
| 233 | in which office surgery is performed. |
| 234 | Section 6. Subsection (2) of section 459.005, Florida |
| 235 | Statutes, is amended to read: |
| 236 | 459.005 Rulemaking authority.-- |
| 237 | (2) All physicians who perform level 2 procedures lasting |
| 238 | more than 5 minutes and all level 3 surgical procedures in an |
| 239 | office setting must register the office with the department |
| 240 | unless that office is licensed as a facility pursuant to chapter |
| 241 | 395. The department shall inspect the physician's office |
| 242 | annually unless the office is accredited by a nationally |
| 243 | recognized accrediting agency or an accrediting organization |
| 244 | subsequently approved by the Board of Osteopathic Medicine. The |
| 245 | actual costs for registration and inspection or accreditation |
| 246 | shall be paid by the person seeking to register and operate the |
| 247 | office setting in which office surgery is performed. |
| 248 | Section 7. This act shall take effect July 1, 2008. |