1 | A bill to be entitled |
2 | An act relating to sexually transmissible disease testing |
3 | and reporting; amending s. 381.004, F.S.; revising |
4 | criteria for releasing preliminary HIV test results; |
5 | providing that informed consent is not required to test |
6 | pregnant women for HIV; amending s. 384.25, F.S.; |
7 | requiring certain positive test results to be reported to |
8 | the Department of Health within a specified period of |
9 | time; revising provisions relating to method of reporting |
10 | of test results, time period during which the reports must |
11 | be made, content of reports, enforcement requirements, and |
12 | followup activities and requiring the department to adopt |
13 | rules therefor; deleting requirement that the department |
14 | submit certain reports; amending s. 384.31, F.S.; |
15 | requiring informed consent of a pregnant woman before |
16 | performing a test for sexually transmitted diseases; |
17 | requiring documentation if a pregnant woman declines to be |
18 | tested; deleting provision limiting liability of the |
19 | practitioner attending a patient who declined to be |
20 | tested; providing an effective date. |
21 |
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22 | Be It Enacted by the Legislature of the State of Florida: |
23 |
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24 | Section 1. Paragraphs (d) and (h) of subsection (3) of |
25 | section 381.004, Florida Statutes, are amended to read: |
26 | 381.004 HIV testing.-- |
27 | (3) HUMAN IMMUNODEFICIENCY VIRUS TESTING; INFORMED |
28 | CONSENT; RESULTS; COUNSELING; CONFIDENTIALITY.-- |
29 | (d) No positive preliminary test result shall be |
30 | determined as positive, and no positive test result shall be |
31 | revealed to any person, without corroborating or confirmatory |
32 | tests being conducted except in the following situations: |
33 | 1. Preliminary test results may be released to licensed |
34 | physicians or the medical or nonmedical personnel subject to the |
35 | significant exposure for purposes of subparagraphs (h)10., 11., |
36 | and 12. |
37 | 2. Preliminary test results may be released to health care |
38 | providers and to the person tested when decisions about medical |
39 | care or treatment of, or recommendation to, the person tested |
40 | and, in the case of an intrapartum or postpartum woman, when |
41 | care, treatment, or recommendations regarding her newborn, |
42 | cannot await the results of confirmatory testing. Positive |
43 | preliminary HIV test results shall not be characterized to the |
44 | patient as a diagnosis of HIV infection. Justification for the |
45 | use of preliminary test results must be documented in the |
46 | medical record by the health care provider who ordered the test. |
47 | This subparagraph does not authorize the release of preliminary |
48 | test results for the purpose of routine identification of HIV- |
49 | infected individuals or when HIV testing is incidental to the |
50 | preliminary diagnosis or care of a patient. |
51 | 3. The results of rapid testing technologies shall be |
52 | considered preliminary and may be released in accordance with |
53 | the manufacturer's instructions as approved by the federal Food |
54 | and Drug Administration. |
55 | 4. Corroborating or confirmatory testing must be conducted |
56 | as followup to a positive preliminary test. Results shall be |
57 | communicated to the patient according to statute regardless of |
58 | the outcome. Except as provided in this section, test results |
59 | are confidential and exempt from the provisions of s. 119.07(1). |
60 | (h) Notwithstanding the provisions of paragraph (a), |
61 | informed consent is not required: |
62 | 1. When testing for sexually transmissible diseases is |
63 | required by state or federal law, or by rule including the |
64 | following situations: |
65 | a. HIV testing pursuant to s. 796.08 of persons convicted |
66 | of prostitution or of procuring another to commit prostitution. |
67 | b. HIV testing of inmates pursuant to s. 945.355 prior to |
68 | their release from prison by reason of parole, accumulation of |
69 | gain-time credits, or expiration of sentence. |
70 | c. Testing for HIV by a medical examiner in accordance |
71 | with s. 406.11. |
72 | d. HIV testing of pregnant women pursuant to s. 384.31. |
73 | 2. Those exceptions provided for blood, plasma, organs, |
74 | skin, semen, or other human tissue pursuant to s. 381.0041. |
75 | 3. For the performance of an HIV-related test by licensed |
76 | medical personnel in bona fide medical emergencies when the test |
77 | results are necessary for medical diagnostic purposes to provide |
78 | appropriate emergency care or treatment to the person being |
79 | tested and the patient is unable to consent, as supported by |
80 | documentation in the medical record. Notification of test |
81 | results in accordance with paragraph (c) is required. |
82 | 4. For the performance of an HIV-related test by licensed |
83 | medical personnel for medical diagnosis of acute illness where, |
84 | in the opinion of the attending physician, obtaining informed |
85 | consent would be detrimental to the patient, as supported by |
86 | documentation in the medical record, and the test results are |
87 | necessary for medical diagnostic purposes to provide appropriate |
88 | care or treatment to the person being tested. Notification of |
89 | test results in accordance with paragraph (c) is required if it |
90 | would not be detrimental to the patient. This subparagraph does |
91 | not authorize the routine testing of patients for HIV infection |
92 | without informed consent. |
93 | 5. When HIV testing is performed as part of an autopsy for |
94 | which consent was obtained pursuant to s. 872.04. |
95 | 6. For the performance of an HIV test upon a defendant |
96 | pursuant to the victim's request in a prosecution for any type |
97 | of sexual battery where a blood sample is taken from the |
98 | defendant voluntarily, pursuant to court order for any purpose, |
99 | or pursuant to the provisions of s. 775.0877, s. 951.27, or s. |
100 | 960.003; however, the results of any HIV test performed shall be |
101 | disclosed solely to the victim and the defendant, except as |
102 | provided in ss. 775.0877, 951.27, and 960.003. |
103 | 7. When an HIV test is mandated by court order. |
104 | 8. For epidemiological research pursuant to s. 381.0032, |
105 | for research consistent with institutional review boards created |
106 | by 45 C.F.R. part 46, or for the performance of an HIV-related |
107 | test for the purpose of research, if the testing is performed in |
108 | a manner by which the identity of the test subject is not known |
109 | and may not be retrieved by the researcher. |
110 | 9. When human tissue is collected lawfully without the |
111 | consent of the donor for corneal removal as authorized by s. |
112 | 765.5185 or enucleation of the eyes as authorized by s. 765.519. |
113 | 10. For the performance of an HIV test upon an individual |
114 | who comes into contact with medical personnel in such a way that |
115 | a significant exposure has occurred during the course of |
116 | employment or within the scope of practice and where a blood |
117 | sample is available that was taken from that individual |
118 | voluntarily by medical personnel for other purposes. The term |
119 | "medical personnel" includes a licensed or certified health care |
120 | professional; an employee of a health care professional or |
121 | health care facility; employees of a laboratory licensed under |
122 | chapter 483; personnel of a blood bank or plasma center; a |
123 | medical student or other student who is receiving training as a |
124 | health care professional at a health care facility; and a |
125 | paramedic or emergency medical technician certified by the |
126 | department to perform life-support procedures under s. 401.23. |
127 | a. Prior to performance of an HIV test on a voluntarily |
128 | obtained blood sample, the individual from whom the blood was |
129 | obtained shall be requested to consent to the performance of the |
130 | test and to the release of the results. The individual's refusal |
131 | to consent and all information concerning the performance of an |
132 | HIV test and any HIV test result shall be documented only in the |
133 | medical personnel's record unless the individual gives written |
134 | consent to entering this information on the individual's medical |
135 | record. |
136 | b. Reasonable attempts to locate the individual and to |
137 | obtain consent shall be made, and all attempts must be |
138 | documented. If the individual cannot be found, an HIV test may |
139 | be conducted on the available blood sample. If the individual |
140 | does not voluntarily consent to the performance of an HIV test, |
141 | the individual shall be informed that an HIV test will be |
142 | performed, and counseling shall be furnished as provided in this |
143 | section. However, HIV testing shall be conducted only after a |
144 | licensed physician documents, in the medical record of the |
145 | medical personnel, that there has been a significant exposure |
146 | and that, in the physician's medical judgment, the information |
147 | is medically necessary to determine the course of treatment for |
148 | the medical personnel. |
149 | c. Costs of any HIV test of a blood sample performed with |
150 | or without the consent of the individual, as provided in this |
151 | subparagraph, shall be borne by the medical personnel or the |
152 | employer of the medical personnel. However, costs of testing or |
153 | treatment not directly related to the initial HIV tests or costs |
154 | of subsequent testing or treatment shall not be borne by the |
155 | medical personnel or the employer of the medical personnel. |
156 | d. In order to utilize the provisions of this |
157 | subparagraph, the medical personnel must either be tested for |
158 | HIV pursuant to this section or provide the results of an HIV |
159 | test taken within 6 months prior to the significant exposure if |
160 | such test results are negative. |
161 | e. A person who receives the results of an HIV test |
162 | pursuant to this subparagraph shall maintain the confidentiality |
163 | of the information received and of the persons tested. Such |
164 | confidential information is exempt from s. 119.07(1). |
165 | f. If the source of the exposure will not voluntarily |
166 | submit to HIV testing and a blood sample is not available, the |
167 | medical personnel or the employer of such person acting on |
168 | behalf of the employee may seek a court order directing the |
169 | source of the exposure to submit to HIV testing. A sworn |
170 | statement by a physician licensed under chapter 458 or chapter |
171 | 459 that a significant exposure has occurred and that, in the |
172 | physician's medical judgment, testing is medically necessary to |
173 | determine the course of treatment constitutes probable cause for |
174 | the issuance of an order by the court. The results of the test |
175 | shall be released to the source of the exposure and to the |
176 | person who experienced the exposure. |
177 | 11. For the performance of an HIV test upon an individual |
178 | who comes into contact with medical personnel in such a way that |
179 | a significant exposure has occurred during the course of |
180 | employment or within the scope of practice of the medical |
181 | personnel while the medical personnel provides emergency medical |
182 | treatment to the individual; or who comes into contact with |
183 | nonmedical personnel in such a way that a significant exposure |
184 | has occurred while the nonmedical personnel provides emergency |
185 | medical assistance during a medical emergency. For the purposes |
186 | of this subparagraph, a medical emergency means an emergency |
187 | medical condition outside of a hospital or health care facility |
188 | that provides physician care. The test may be performed only |
189 | during the course of treatment for the medical emergency. |
190 | a. An individual who is capable of providing consent shall |
191 | be requested to consent to an HIV test prior to the testing. The |
192 | individual's refusal to consent, and all information concerning |
193 | the performance of an HIV test and its result, shall be |
194 | documented only in the medical personnel's record unless the |
195 | individual gives written consent to entering this information on |
196 | the individual's medical record. |
197 | b. HIV testing shall be conducted only after a licensed |
198 | physician documents, in the medical record of the medical |
199 | personnel or nonmedical personnel, that there has been a |
200 | significant exposure and that, in the physician's medical |
201 | judgment, the information is medically necessary to determine |
202 | the course of treatment for the medical personnel or nonmedical |
203 | personnel. |
204 | c. Costs of any HIV test performed with or without the |
205 | consent of the individual, as provided in this subparagraph, |
206 | shall be borne by the medical personnel or the employer of the |
207 | medical personnel or nonmedical personnel. However, costs of |
208 | testing or treatment not directly related to the initial HIV |
209 | tests or costs of subsequent testing or treatment shall not be |
210 | borne by the medical personnel or the employer of the medical |
211 | personnel or nonmedical personnel. |
212 | d. In order to utilize the provisions of this |
213 | subparagraph, the medical personnel or nonmedical personnel |
214 | shall be tested for HIV pursuant to this section or shall |
215 | provide the results of an HIV test taken within 6 months prior |
216 | to the significant exposure if such test results are negative. |
217 | e. A person who receives the results of an HIV test |
218 | pursuant to this subparagraph shall maintain the confidentiality |
219 | of the information received and of the persons tested. Such |
220 | confidential information is exempt from s. 119.07(1). |
221 | f. If the source of the exposure will not voluntarily |
222 | submit to HIV testing and a blood sample was not obtained during |
223 | treatment for the medical emergency, the medical personnel, the |
224 | employer of the medical personnel acting on behalf of the |
225 | employee, or the nonmedical personnel may seek a court order |
226 | directing the source of the exposure to submit to HIV testing. A |
227 | sworn statement by a physician licensed under chapter 458 or |
228 | chapter 459 that a significant exposure has occurred and that, |
229 | in the physician's medical judgment, testing is medically |
230 | necessary to determine the course of treatment constitutes |
231 | probable cause for the issuance of an order by the court. The |
232 | results of the test shall be released to the source of the |
233 | exposure and to the person who experienced the exposure. |
234 | 12. For the performance of an HIV test by the medical |
235 | examiner or attending physician upon an individual who expired |
236 | or could not be resuscitated while receiving emergency medical |
237 | assistance or care and who was the source of a significant |
238 | exposure to medical or nonmedical personnel providing such |
239 | assistance or care. |
240 | a. HIV testing may be conducted only after a licensed |
241 | physician documents in the medical record of the medical |
242 | personnel or nonmedical personnel that there has been a |
243 | significant exposure and that, in the physician's medical |
244 | judgment, the information is medically necessary to determine |
245 | the course of treatment for the medical personnel or nonmedical |
246 | personnel. |
247 | b. Costs of any HIV test performed under this subparagraph |
248 | may not be charged to the deceased or to the family of the |
249 | deceased person. |
250 | c. For the provisions of this subparagraph to be |
251 | applicable, the medical personnel or nonmedical personnel must |
252 | be tested for HIV under this section or must provide the results |
253 | of an HIV test taken within 6 months before the significant |
254 | exposure if such test results are negative. |
255 | d. A person who receives the results of an HIV test |
256 | pursuant to this subparagraph shall comply with paragraph (e). |
257 | 13. For the performance of an HIV-related test medically |
258 | indicated by licensed medical personnel for medical diagnosis of |
259 | a hospitalized infant as necessary to provide appropriate care |
260 | and treatment of the infant when, after a reasonable attempt, a |
261 | parent cannot be contacted to provide consent. The medical |
262 | records of the infant shall reflect the reason consent of the |
263 | parent was not initially obtained. Test results shall be |
264 | provided to the parent when the parent is located. |
265 | 14. For the performance of HIV testing conducted to |
266 | monitor the clinical progress of a patient previously diagnosed |
267 | to be HIV positive. |
268 | 15. For the performance of repeated HIV testing conducted |
269 | to monitor possible conversion from a significant exposure. |
270 | Section 2. Section 384.25, Florida Statutes, is amended to |
271 | read: |
272 | 384.25 Reporting required.-- |
273 | (1) Each person who makes a diagnosis of or treats a |
274 | person with a sexually transmissible disease and each laboratory |
275 | that performs a test for a sexually transmissible disease which |
276 | either concludes with a positive result for a sexually |
277 | transmissible disease or a result indicative of human |
278 | immunodeficiency virus (HIV) or acquired immune deficiency |
279 | syndrome (AIDS) shall report such facts as may be required by |
280 | the department by rule, within a time period as specified by |
281 | rule of the department, but in no case to exceed 2 weeks. |
282 | (2) The department shall adopt rules specifying the |
283 | information required in and the maximum a minimum time period |
284 | for reporting a sexually transmissible disease. In adopting such |
285 | rules, the department shall consider the need for information, |
286 | protections for the privacy and confidentiality of the patient, |
287 | and the practical ability of persons and laboratories to report |
288 | in a reasonable fashion. |
289 | (3) To ensure the confidentiality of persons infected with |
290 | the human immunodeficiency virus (HIV), reporting of HIV |
291 | infection and AIDS acquired immune deficiency syndrome (AIDS) |
292 | must be conducted using a system the HIV/AIDS Reporting System |
293 | (HARS) developed by the Centers for Disease Control and |
294 | Prevention of the United States Public Health Service or an |
295 | equivalent system. |
296 | (a) The department shall adopt rules requiring each |
297 | physician and laboratory to report any newborn or infant up to |
298 | 18 months of age who has been exposed to HIV. Such rules may |
299 | include the method and time period for reporting which may not |
300 | exceed 2 weeks, information to be included in the report, |
301 | enforcement requirements, and followup activities by the |
302 | department. |
303 | (3) The department shall require reporting of physician |
304 | diagnosed cases of AIDS based upon diagnostic criteria from the |
305 | Centers for Disease Control and Prevention. |
306 | (b)(4) The department may require physician and laboratory |
307 | reporting of HIV infection. However, only reports of HIV |
308 | infection identified on or after the effective date of the rule |
309 | developed by the department pursuant to this subsection shall be |
310 | accepted. The reporting may not affect or relate to anonymous |
311 | HIV testing programs conducted pursuant to s. 381.004(4) or to |
312 | university-based medical research protocols as determined by the |
313 | department. |
314 | (c)(5) After notification of the test subject under |
315 | subsection (4), the department may, with the consent of the test |
316 | subject, notify school superintendents of students and school |
317 | personnel whose HIV tests are positive. |
318 | (6) The department shall by February 1 of each year submit |
319 | to the Legislature an annual report relating to all information |
320 | obtained pursuant to this section. |
321 | (4)(7) Each person who violates the provisions of this |
322 | section or the rules adopted hereunder may be fined by the |
323 | department up to $500 for each offense. The department shall |
324 | report each violation of this section to the regulatory agency |
325 | responsible for licensing each health care professional and each |
326 | laboratory to which these provisions apply. |
327 | Section 3. Section 384.31, Florida Statutes, is amended to |
328 | read: |
329 | 384.31 Serological Testing of pregnant women; duty of the |
330 | attendant.-- |
331 | (1) Every person, including every physician licensed under |
332 | chapter 458 or chapter 459 or midwife licensed under part I of |
333 | chapter 464 or chapter 467, attending a pregnant woman for |
334 | conditions relating to pregnancy during the period of gestation |
335 | and delivery shall take or cause the woman to be tested for |
336 | sexually transmissible diseases, including HIV, as taken a |
337 | sample of venous blood at a time or times specified by the |
338 | department rule. Testing Each sample of blood shall be conducted |
339 | tested by a laboratory approved for such purposes under part I |
340 | of chapter 483 for sexually transmissible diseases as required |
341 | by rule of the department. The woman shall be informed of the |
342 | tests that will be conducted and of her right to refuse testing. |
343 | If the pregnant woman objects to testing, a written statement of |
344 | objection, signed by the woman, shall be placed in the patient's |
345 | medical record and no testing shall occur. |
346 | (2) At the time the venous blood sample is taken, testing |
347 | for human immunodeficiency virus (HIV) infection shall be |
348 | offered to each pregnant woman. The prevailing professional |
349 | standard of care in this state requires each health care |
350 | provider and midwife who attends a pregnant woman to counsel the |
351 | woman to be tested for human immunodeficiency virus (HIV). |
352 | Counseling shall include a discussion of the availability of |
353 | treatment if the pregnant woman tests HIV positive. If a |
354 | pregnant woman objects to HIV testing, reasonable steps shall be |
355 | taken to obtain a written statement of such objection, signed by |
356 | the patient, which shall be placed in the patient's medical |
357 | record. Every person, including every physician licensed under |
358 | chapter 458 or chapter 459 or midwife licensed under part I of |
359 | chapter 464 or chapter 467, who attends a pregnant woman who has |
360 | been offered and objects to HIV testing shall be immune from |
361 | liability arising out of or related to the contracting of HIV |
362 | infection or acquired immune deficiency syndrome (AIDS) by the |
363 | child from the mother. |
364 | Section 4. This act shall take effect July 1, 2005. |