15 | 15 | | An act relating to health care provider 2 |
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16 | 16 | | accountability; amending s. 400.022, F.S.; revising 3 |
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17 | 17 | | the rights of licensed nursing home facility 4 |
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18 | 18 | | residents; providing definitions; amending s. 408.812, 5 |
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19 | 19 | | F.S.; creating a cause of action for an ex parte 6 |
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20 | 20 | | temporary injunction against continued unlicensed 7 |
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21 | 21 | | activity; providing requirements for such injunction; 8 |
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22 | 22 | | providing construction; authorizing the Agency for 9 |
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23 | 23 | | Health Care Administration to provide certain records 10 |
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24 | 24 | | to local law enforcement and state attorneys' offices 11 |
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25 | 25 | | under certain circumstances; amending ss. 458.328 and 12 |
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26 | 26 | | 459.0138, F.S.; requiring the Department of Health to 13 |
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27 | 27 | | complete an inspection of any physician′s office 14 |
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28 | 28 | | seeking registration to perform office surgeries 15 |
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29 | 29 | | before the office may be registered; requiring 16 |
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30 | 30 | | immediate suspension of a registration under specified 17 |
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31 | 31 | | circumstances; requiring such offices to remain closed 18 |
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32 | 32 | | for the duration of any suspensions; requiring a 19 |
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33 | 33 | | suspension to remain in effect for a specified 20 |
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34 | 34 | | timeframe; requiring physicians performing gluteal fat 21 |
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35 | 35 | | grafting procedures in an office surgery setting to 22 |
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36 | 36 | | adhere to specified standards of practice; specifying 23 |
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37 | 37 | | surgeries that may not be performed in an office 24 |
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38 | 38 | | surgery setting; requiring physicians performing 25 |
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46 | 46 | | Page 2 of 12 |
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47 | 47 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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48 | 48 | | |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | gluteal fat grafting procedures to conduct in -person 26 |
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52 | 52 | | examinations of the patients; requiring the reporting 27 |
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53 | 53 | | of specified adverse incidents; providing requirements 28 |
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54 | 54 | | for the performance of gluteal fat grafting 29 |
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55 | 55 | | procedures; providing an effective date. 30 |
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56 | 56 | | 31 |
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57 | 57 | | Be It Enacted by the Legislature of the State of Florida: 32 |
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58 | 58 | | 33 |
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59 | 59 | | Section 1. Paragraph (o) of subsection (1) of section 34 |
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60 | 60 | | 400.022, Florida Statutes, is amended to read: 35 |
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61 | 61 | | 400.022 Residents' rights. — 36 |
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62 | 62 | | (1) All licensees of nursing home facilities shall adopt 37 |
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63 | 63 | | and make public a statement of the rights and responsibilities 38 |
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64 | 64 | | of the residents of such facilities and shall treat such 39 |
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65 | 65 | | residents in accordance with the provisions of that statement. 40 |
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66 | 66 | | The statement shall assure each resident the following: 41 |
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67 | 67 | | (o) The right to be free from mental and physical abuse, 42 |
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68 | 68 | | sexual abuse, neglect, exploitation, corporal punishment, 43 |
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69 | 69 | | extended involuntary seclusion, and from physical and chemical 44 |
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70 | 70 | | restraints, except those restraints authorized in writing by a 45 |
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71 | 71 | | physician for a specified and limited period of time or as are 46 |
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72 | 72 | | necessitated by an emergency. In case of an emergency, restraint 47 |
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73 | 73 | | may be applied only by a qualified licensed nurse who shall set 48 |
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74 | 74 | | forth in writing the circumstances requiring the use of 49 |
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75 | 75 | | restraint, and, in the case of use of a chemical restraint, a 50 |
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83 | 83 | | Page 3 of 12 |
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84 | 84 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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85 | 85 | | |
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86 | 86 | | |
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87 | 87 | | |
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88 | 88 | | physician shall be consulted immediately thereafter. Restraints 51 |
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89 | 89 | | may not be used in lieu of staff supervision or merely for staff 52 |
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90 | 90 | | convenience, for punishment, or for reasons other than resident 53 |
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91 | 91 | | protection or safety. For purposes of this paragraph, the terms 54 |
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92 | 92 | | "sexual abuse," "neglect," and "exploita tion" have the same 55 |
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93 | 93 | | meanings as provided in 42 C.F.R. s. 483.5. 56 |
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94 | 94 | | Section 2. Subsection (6) of section 408.812, Florida 57 |
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95 | 95 | | Statutes, is amended to read: 58 |
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96 | 96 | | 408.812 Unlicensed activity. — 59 |
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97 | 97 | | (6) In addition to granting injunctive relief pursuant to 60 |
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98 | 98 | | subsection (2), if the agency determines that a person or entity 61 |
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99 | 99 | | is operating or maintaining a provider without obtaining a 62 |
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100 | 100 | | license and determines that a condition exists that poses a 63 |
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101 | 101 | | threat to the health, safety, or welfare of a client of the 64 |
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102 | 102 | | provider, the person or entity is subject to the same actions 65 |
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103 | 103 | | and fines imposed against a licensee as specified in this part, 66 |
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104 | 104 | | authorizing statutes, and agency rules. 67 |
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105 | 105 | | (a) There is created a cause of action for an ex parte 68 |
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106 | 106 | | temporary injunction against continued unlicensed activit y by a 69 |
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107 | 107 | | person or entity violating subsection (1), not to exceed 30 70 |
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108 | 108 | | days. 71 |
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109 | 109 | | (b) A sworn petition seeking the issuance of an ex parte 72 |
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110 | 110 | | temporary injunction against continued unlicensed activity shall 73 |
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111 | 111 | | allege all of the following: 74 |
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112 | 112 | | 1. The location of the unlic ensed activity. 75 |
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120 | 120 | | Page 4 of 12 |
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121 | 121 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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122 | 122 | | |
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123 | 123 | | |
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124 | 124 | | |
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125 | 125 | | 2. The names of the owners and operators of the unlicensed 76 |
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126 | 126 | | provider. 77 |
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127 | 127 | | 3. The type of services that require licensure. 78 |
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128 | 128 | | 4. The specific facts supporting the conclusion that the 79 |
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129 | 129 | | unlicensed provider is engaged in unlicensed activity, including 80 |
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130 | 130 | | the date, time, and location at which the unlicensed provider 81 |
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131 | 131 | | was notified by the agency to discontinue such activity. 82 |
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132 | 132 | | 5. That agency personnel have verified, through an onsite 83 |
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133 | 133 | | inspection, that the unlicensed provider is advertising, 84 |
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134 | 134 | | offering, or providing services that require licensure. 85 |
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135 | 135 | | 6. Whether the unlicensed provider prohibited the agency 86 |
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136 | 136 | | from conducting a subsequent investigation to determine current 87 |
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137 | 137 | | compliance with applicable laws and rules. 88 |
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138 | 138 | | 7. Any previous injunctive relief granted against the 89 |
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139 | 139 | | unlicensed provider. 90 |
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140 | 140 | | 8. Any previous agency determination that the unlicensed 91 |
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141 | 141 | | provider has been identified as engaging in unlicensed activity. 92 |
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142 | 142 | | (c) A bond may not be required by the court for entry of 93 |
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143 | 143 | | an ex parte temporary injunction. 94 |
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144 | 144 | | (d) Except as provided in s. 90.204, in a hearing to 95 |
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145 | 145 | | obtain an ex parte temporary injunction, evidence other than 96 |
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146 | 146 | | verified pleadings or affidavits by agency personnel or others 97 |
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147 | 147 | | with firsthand knowledge of the alleged unlicensed activity may 98 |
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148 | 148 | | not be used as evidence, unless the unlicensed provider appears 99 |
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149 | 149 | | at the hearing. A denial of a petition for an ex parte temporary 100 |
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157 | 157 | | Page 5 of 12 |
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158 | 158 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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159 | 159 | | |
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160 | 160 | | |
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161 | 161 | | |
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162 | 162 | | injunction shall specify the grounds for denial in writing. 101 |
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163 | 163 | | (e) If the court determines that the unlicensed provider 102 |
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164 | 164 | | is engaged in continued unl icensed activity after agency 103 |
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165 | 165 | | notification to cease such unlicensed activity, the court may 104 |
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166 | 166 | | grant the ex parte temporary injunction restraining the 105 |
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167 | 167 | | unlicensed provider from advertising, offering, or providing 106 |
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168 | 168 | | services for which licensure is required. The c ourt may also 107 |
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169 | 169 | | order the unlicensed provider to provide to agency personnel 108 |
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170 | 170 | | access to facility personnel, records, and clients for future 109 |
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171 | 171 | | inspection of the unlicensed provider's premises. 110 |
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172 | 172 | | (f) The agency must inspect the unlicensed provider's 111 |
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173 | 173 | | premises within 20 days after entry of the ex parte temporary 112 |
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174 | 174 | | injunction to verify compliance with such injunction. If the 113 |
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175 | 175 | | unlicensed provider is in compliance, the agency shall dismiss 114 |
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176 | 176 | | the injunction. If unlicensed activity has continued, the agency 115 |
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177 | 177 | | may file a petition for permanent injunction within 10 days 116 |
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178 | 178 | | after identifying noncompliance. The agency may also petition to 117 |
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179 | 179 | | extend the ex parte temporary injunction until the permanent 118 |
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180 | 180 | | injunction is decided. 119 |
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181 | 181 | | (g) The agency may provide any inspection records to local 120 |
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182 | 182 | | law enforcement or a state attorney's office upon request and 121 |
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183 | 183 | | without redaction. 122 |
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184 | 184 | | Section 3. Present subsection (2) of section 458.328, 123 |
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185 | 185 | | Florida Statutes, is redesignated as subsection (3), a new 124 |
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186 | 186 | | subsection (2) is added to that section, and paragraphs (a) an d 125 |
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194 | 194 | | Page 6 of 12 |
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195 | 195 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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196 | 196 | | |
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197 | 197 | | |
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198 | 198 | | |
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199 | 199 | | (e) of subsection (1) of that section are amended, to read: 126 |
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200 | 200 | | 458.328 Office surgeries. — 127 |
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201 | 201 | | (1) REGISTRATION.— 128 |
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202 | 202 | | (a)1. An office in which a physician performs a 129 |
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203 | 203 | | liposuction procedure in which more than 1,000 cubic centimeters 130 |
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204 | 204 | | of supernatant fat is removed , a Level II office surgery, or a 131 |
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205 | 205 | | Level III office surgery must register with the department 132 |
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206 | 206 | | unless the office is licensed as a facility under chapter 390 or 133 |
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207 | 207 | | chapter 395. 134 |
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208 | 208 | | 2. The department must complete an inspection of any 135 |
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209 | 209 | | office seeking registration un der this section before the office 136 |
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210 | 210 | | may be registered. 137 |
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211 | 211 | | (e)1. The department shall inspect a registered office at 138 |
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212 | 212 | | least annually, including a review of patient records, to ensure 139 |
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213 | 213 | | that the office is in compliance with this section and rules 140 |
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214 | 214 | | adopted hereunder unless the office is accredited by a 141 |
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215 | 215 | | nationally recognized accrediting agency approved by the board. 142 |
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216 | 216 | | The inspection may be unannounced, except for the inspection of 143 |
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217 | 217 | | an office that meets the description of a clinic specified in s. 144 |
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218 | 218 | | 458.3265(1)(a)3.h., and those wholly owned and operated 145 |
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219 | 219 | | physician offices described in s. 458.3265(1)(a)3.g. which 146 |
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220 | 220 | | perform procedures referenced in s. 458.3265(1)(a)3.h., which 147 |
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221 | 221 | | must be announced. 148 |
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222 | 222 | | 2. The department must immediately suspend the 149 |
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223 | 223 | | registration of a registered office that refuses an inspection 150 |
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231 | 231 | | Page 7 of 12 |
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232 | 232 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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233 | 233 | | |
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234 | 234 | | |
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235 | 235 | | |
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236 | 236 | | under subparagraph 1. The office must close during such 151 |
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237 | 237 | | suspension. The suspension must remain in effect for at least 14 152 |
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238 | 238 | | consecutive days and may not terminate until the department 153 |
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239 | 239 | | issues a written declaration that the office ma y reopen 154 |
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240 | 240 | | following the department′s completion of an inspection of the 155 |
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241 | 241 | | office. 156 |
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242 | 242 | | (2) STANDARDS OF PRACTICE. — 157 |
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243 | 243 | | (a) A physician performing a gluteal fat grafting 158 |
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244 | 244 | | procedure in an office surgery setting shall adhere to standards 159 |
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245 | 245 | | of practice pursuant to this s ubsection and rules adopted by the 160 |
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246 | 246 | | board. 161 |
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247 | 247 | | (b) Office surgeries may not: 162 |
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248 | 248 | | 1. Be a type of surgery that generally results in blood 163 |
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249 | 249 | | loss of more than 10 percent of estimated blood volume in a 164 |
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250 | 250 | | patient with a normal hemoglobin level; 165 |
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251 | 251 | | 2. Require major or pr olonged intracranial, intrathoracic, 166 |
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252 | 252 | | abdominal, or joint replacement procedures, except for 167 |
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253 | 253 | | laparoscopic procedures; 168 |
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254 | 254 | | 3. Involve major blood vessels and be performed with 169 |
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255 | 255 | | direct visualization by open exposure of the major blood vessel, 170 |
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256 | 256 | | except for percutaneous endovascular intervention; or 171 |
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257 | 257 | | 4. Be emergent or life threatening. 172 |
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258 | 258 | | (c)1. A physician performing a gluteal fat grafting 173 |
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259 | 259 | | procedure must conduct an in -person examination of the patient 174 |
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260 | 260 | | while physically present in the same room as the patient no 175 |
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268 | 268 | | Page 8 of 12 |
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269 | 269 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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270 | 270 | | |
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271 | 271 | | |
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272 | 272 | | |
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273 | 273 | | later than the day before the procedure. 176 |
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274 | 274 | | 2. Before a physician may delegate any duties during a 177 |
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275 | 275 | | gluteal fat grafting procedure, the patient must provide 178 |
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276 | 276 | | written, informed consent for such delegation. Any duty 179 |
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277 | 277 | | delegated by a physician during a gluteal fat graft ing procedure 180 |
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278 | 278 | | must be performed under the direct supervision of the physician 181 |
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279 | 279 | | performing such procedure. Fat extraction and gluteal fat 182 |
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280 | 280 | | injections must be performed by the physician and may not be 183 |
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281 | 281 | | delegated. 184 |
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282 | 282 | | 3. Fat may only be injected into the subcutane ous space of 185 |
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283 | 283 | | the patient and may not cross the fascia overlying the gluteal 186 |
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284 | 284 | | muscle. Intramuscular or submuscular fat injections are 187 |
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285 | 285 | | prohibited. 188 |
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286 | 286 | | 4. When the physician performing a gluteal fat grafting 189 |
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287 | 287 | | procedure injects fat into the subcutaneous space of t he 190 |
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288 | 288 | | patient, the physician must use ultrasound guidance, or guidance 191 |
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289 | 289 | | with other technology authorized under board rule which equals 192 |
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290 | 290 | | or exceeds the quality of ultrasound, during the placement and 193 |
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291 | 291 | | navigation of the cannula to ensure that the fat is injected 194 |
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292 | 292 | | into the subcutaneous space of the patient above the fascia 195 |
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293 | 293 | | overlying the gluteal muscle. Such guidance with the use of 196 |
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294 | 294 | | ultrasound or other technology is not required for other 197 |
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295 | 295 | | portions of such procedure. 198 |
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296 | 296 | | (d) If a procedure in an office surgery setting re sults in 199 |
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297 | 297 | | hospitalization, the incident must be reported as an adverse 200 |
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305 | 305 | | Page 9 of 12 |
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306 | 306 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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307 | 307 | | |
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308 | 308 | | |
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309 | 309 | | |
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310 | 310 | | incident pursuant to s. 458.351. 201 |
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311 | 311 | | (e) An office in which a physician performs gluteal fat 202 |
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312 | 312 | | grafting procedures must at all times maintain a ratio of one 203 |
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313 | 313 | | physician to one patient during all phases of the procedure, 204 |
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314 | 314 | | beginning with the administration of anesthesia to the patient 205 |
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315 | 315 | | and concluding with the extubation of the patient. After a 206 |
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316 | 316 | | physician has commenced, and while he or she is engaged in, a 207 |
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317 | 317 | | gluteal fat grafting procedure, the physici an may not commence 208 |
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318 | 318 | | or engage in another gluteal fat grafting procedure or any other 209 |
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319 | 319 | | procedure with another patient at the same time. 210 |
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320 | 320 | | Section 4. Present subsection (2) of section 459.0138, 211 |
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321 | 321 | | Florida Statutes, is redesignated as subsection (3), a new 212 |
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322 | 322 | | subsection (2) is added to that section, and paragraphs (a) and 213 |
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323 | 323 | | (e) of subsection (1) of that section are amended, to read: 214 |
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324 | 324 | | 459.0138 Office surgeries. — 215 |
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325 | 325 | | (1) REGISTRATION.— 216 |
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326 | 326 | | (a)1. An office in which a physician performs a 217 |
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327 | 327 | | liposuction procedure in which more than 1,000 cubic centimeters 218 |
---|
328 | 328 | | of supernatant fat is removed, a Level II office surgery, or a 219 |
---|
329 | 329 | | Level III office surgery must register with the department 220 |
---|
330 | 330 | | unless the office is licensed as a facility under chapter 390 or 221 |
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331 | 331 | | chapter 395. 222 |
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332 | 332 | | 2. The department mu st complete an inspection of any 223 |
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333 | 333 | | office seeking registration under this section before the office 224 |
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334 | 334 | | may be registered. 225 |
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342 | 342 | | Page 10 of 12 |
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343 | 343 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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344 | 344 | | |
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345 | 345 | | |
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346 | 346 | | |
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347 | 347 | | (e)1. The department shall inspect a registered office at 226 |
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348 | 348 | | least annually, including a review of patient records, to ensure 227 |
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349 | 349 | | that the office is in compliance with this section and rules 228 |
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350 | 350 | | adopted hereunder unless the office is accredited by a 229 |
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351 | 351 | | nationally recognized accrediting agency approved by the board. 230 |
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352 | 352 | | The inspection may be unannounced, except for the inspection of 231 |
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353 | 353 | | an office that meets the d escription of clinic specified in s. 232 |
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354 | 354 | | 459.0137(1)(a)3.h., and those wholly owned and operated 233 |
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355 | 355 | | physician offices described in s. 459.0137(1)(a)3.g. which 234 |
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356 | 356 | | perform procedures referenced in s. 459.0137(1)(a)3.h., which 235 |
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357 | 357 | | must be announced. 236 |
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358 | 358 | | 2. The department mus t immediately suspend the 237 |
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359 | 359 | | registration of a registered office that refuses an inspection 238 |
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360 | 360 | | under subparagraph 1. The office must close during such 239 |
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361 | 361 | | suspension. The suspension must remain in effect for at least 14 240 |
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362 | 362 | | consecutive days and may not terminate until t he department 241 |
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363 | 363 | | issues a written declaration that the office may reopen 242 |
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364 | 364 | | following the department′s completion of an inspection of the 243 |
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365 | 365 | | office. 244 |
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366 | 366 | | (2) STANDARDS OF PRACTICE. — 245 |
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367 | 367 | | (a) A physician performing a gluteal fat grafting 246 |
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368 | 368 | | procedure in an office surgery set ting shall adhere to standards 247 |
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369 | 369 | | of practice pursuant to this subsection and rules adopted by the 248 |
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370 | 370 | | board. 249 |
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371 | 371 | | (b) Office surgeries may not: 250 |
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379 | 379 | | Page 11 of 12 |
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380 | 380 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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381 | 381 | | |
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382 | 382 | | |
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383 | 383 | | |
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384 | 384 | | 1. Be a type of surgery that generally results in blood 251 |
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385 | 385 | | loss of more than 10 percent of estimated blood volume in a 252 |
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386 | 386 | | patient with a normal hemoglobin level; 253 |
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387 | 387 | | 2. Require major or prolonged intracranial, intrathoracic, 254 |
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388 | 388 | | abdominal, or joint replacement procedures, except for 255 |
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389 | 389 | | laparoscopic procedures; 256 |
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390 | 390 | | 3. Involve major blood vessels and be performed with 257 |
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391 | 391 | | direct visualization by open exposure of the major blood vessel, 258 |
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392 | 392 | | except for percutaneous endovascular intervention; or 259 |
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393 | 393 | | 4. Be emergent or life threatening. 260 |
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394 | 394 | | (c)1. A physician performing a gluteal fat grafting 261 |
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395 | 395 | | procedure must conduct an in -person examination of the patient 262 |
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396 | 396 | | while physically present in the same room as the patient no 263 |
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397 | 397 | | later than the day before the procedure. 264 |
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398 | 398 | | 2. Before a physician may delegate any duties during a 265 |
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399 | 399 | | gluteal fat grafting procedure, the patient must provide 266 |
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400 | 400 | | written, informed consent for such delegation. Any duty 267 |
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401 | 401 | | delegated by a physician during a gluteal fat grafting procedure 268 |
---|
402 | 402 | | must be performed under the direct supervision of the physician 269 |
---|
403 | 403 | | performing such procedure. Fat extraction and gluteal fat 270 |
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404 | 404 | | injections must be performed by the physician and may not b e 271 |
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405 | 405 | | delegated. 272 |
---|
406 | 406 | | 3. Fat may only be injected into the subcutaneous space of 273 |
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407 | 407 | | the patient and may not cross the fascia overlying the gluteal 274 |
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408 | 408 | | muscle. Intramuscular or submuscular fat injections are 275 |
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416 | 416 | | Page 12 of 12 |
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417 | 417 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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418 | 418 | | |
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419 | 419 | | |
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420 | 420 | | |
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421 | 421 | | prohibited. 276 |
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422 | 422 | | 4. When the physician performing a gluteal fat gr afting 277 |
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423 | 423 | | procedure injects fat into the subcutaneous space of the 278 |
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424 | 424 | | patient, the physician must use ultrasound guidance, or guidance 279 |
---|
425 | 425 | | with other technology authorized under board rule which equals 280 |
---|
426 | 426 | | or exceeds the quality of ultrasound, during the placement and 281 |
---|
427 | 427 | | navigation of the cannula to ensure that the fat is injected 282 |
---|
428 | 428 | | into the subcutaneous space of the patient above the fascia 283 |
---|
429 | 429 | | overlying the gluteal muscle. Such guidance with the use of 284 |
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430 | 430 | | ultrasound or other technology is not required for other 285 |
---|
431 | 431 | | portions of such procedure. 286 |
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432 | 432 | | (d) If a procedure in an office surgery setting results in 287 |
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433 | 433 | | hospitalization, the incident must be reported as an adverse 288 |
---|
434 | 434 | | incident pursuant to s. 458.351. 289 |
---|
435 | 435 | | (e) An office in which a physician performs gluteal fat 290 |
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436 | 436 | | grafting procedures must at all ti mes maintain a ratio of one 291 |
---|
437 | 437 | | physician to one patient during all phases of the procedure, 292 |
---|
438 | 438 | | beginning with the administration of anesthesia to the patient 293 |
---|
439 | 439 | | and concluding with the extubation of the patient. After a 294 |
---|
440 | 440 | | physician has commenced, and while he or she is engaged in, a 295 |
---|
441 | 441 | | gluteal fat grafting procedure, the physician may not commence 296 |
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442 | 442 | | or engage in another gluteal fat grafting procedure or any other 297 |
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443 | 443 | | procedure with another patient at the same time. 298 |
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444 | 444 | | Section 5. This act shall take effect July 1, 2023. 299 |
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