Bill Text: FL S2586 | 2010 | Regular Session | Introduced

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Bill Title: Health Care Regulation [SPSC]

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Failed) 2010-04-30 - Died in Committee on Health Regulation [S2586 Detail]

Download: Florida-2010-S2586-Introduced.html

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Florida Senate - 2010                                    SB 2586 
 
By Senator Rich 
34-01598A-10                                          20102586__ 
1                        A bill to be entitled 
2         An act relating to health care regulation; amending s. 
3         395.0197, F.S.; revising provisions relating to the 
4         requirement for certain medical facilities to maintain 
5         an internal risk management program and submit adverse 
6         incident reports; amending s. 395.3025, F.S.; 
7         substituting the Department of Health for the Agency 
8         for Health Care Regulation with respect to the use of 
9         patient records in disciplinary proceedings; amending 
10         s. 400.462, F.S.; revising definitions relating to 
11         home health care services; amending s. 400.476, F.S.; 
12         revising provisions relating to home health care 
13         staffing requirements; clarifying that an alternate 
14         administrator must meet the same standards as an 
15         administrator; specifying training requirements for 
16         home health aides; providing contractual requirements 
17         for home health agency personnel; requiring at least 
18         one home health agency service to be provided by 
19         agency employees; creating s. 400.4775, F.S.; 
20         specifying the duties and responsibilities for the 
21         home health agency administrator, director of nursing, 
22         nurses, therapists, home health aides, and certified 
23         nursing assistants; amending s. 400.487, F.S.; 
24         revising provisions relating to home health service 
25         agreements, plans of care, and the supervision of 
26         services; specifying requirements for the provision of 
27         drugs and treatment orders; creating s. 400.493, F.S.; 
28         providing patients’ rights for persons receiving home 
29         health services; requiring the home health agency to 
30         investigate complaints; requiring the agency to 
31         furnish the patient with written notice of such 
32         rights; amending s. 400.933, F.S.; revising provisions 
33         relating to the Agency for Health Care 
34         Administration’s acceptance of inspections conducted 
35         by accrediting organizations; amending s. 400.969, 
36         F.S.; revising the grounds for imposing penalties 
37         against intermediate care facilities for 
38         developmentally disabled persons; amending s. 408.05, 
39         F.S.; directing the Florida Center for Health 
40         Information and Policy Analysis to collect data on 
41         patient safety in health facilities; amending s. 
42         408.7056, F.S.; conforming a cross-reference; amending 
43         s. 408.805, F.S.; revising provisions relating to the 
44         calculation of license fees charged by the agency; 
45         amending s. 408.811, F.S.; clarifying that agency 
46         inspection reports are not subject to administrative 
47         challenges; amending s. 429.65, F.S.; revising 
48         definitions relating to adult family-care homes to 
49         require the provider to reside in the home; amending 
50         ss. 458.331 and 459.015, F.S.; conforming cross 
51         references; amending s. 641.55, F.S.; revising 
52         provisions relating to the requirement for managed 
53         care organizations to maintain an internal risk 
54         management program and submit adverse incident 
55         reports; requiring the State Fire Marshal to conduct a 
56         study of the adequacy of firesafety standards in 
57         assisted living facilities; requiring a report to the 
58         Governor and Legislature; providing effective dates. 
59 
60  Be It Enacted by the Legislature of the State of Florida: 
61 
62         Section 1. Effective January 1, 2011, section 395.0197, 
63  Florida Statutes, is amended to read: 
64         395.0197 Internal risk management program.— 
65         (1) Every licensed facility shall, As a part of its 
66  administrative functions, each licensed facility shall establish 
67  an internal risk management program that includes all of the 
68  following components: 
69         (a) The investigation and analysis of the frequency and 
70  causes of general categories and specific types of adverse 
71  incidents causing injury to patients. 
72         (b) The development of appropriate measures to minimize the 
73  risk of adverse incidents causing injury to patients, including, 
74  but not limited to: 
75         1. Risk management and risk prevention education and 
76  training of all nonphysician personnel as follows: 
77         a. Such Education and training of all nonphysician 
78  personnel as part of their initial orientation; and 
79         b. At least 1 hour of such education and training annually 
80  for all personnel of the licensed facility working in clinical 
81  areas and providing patient care, except those persons licensed 
82  as health care practitioners who are required to complete 
83  continuing education coursework pursuant to chapter 456 or their 
84  the respective practice act. 
85         2. A prohibition, Except when emergency circumstances 
86  require otherwise, a prohibition against a staff member of the 
87  licensed facility attending a patient in the recovery room, 
88  unless the staff member is authorized to attend the patient in 
89  the recovery room and is in the company of at least one other 
90  person. However, a licensed facility is exempt from the two 
91  person requirement if it has: 
92         a. Live visual observation; 
93         b. Electronic observation; or 
94         c. Any other reasonable measure taken to ensure patient 
95  protection and privacy. 
96         3. A prohibition against an unlicensed person from 
97  assisting or participating in any surgical procedure unless the 
98  facility has authorized the person to do so following a 
99  competency assessment, and such assistance or participation is 
100  done under the direct and immediate supervision of a licensed 
101  physician and is not otherwise an activity that may only be 
102  performed by a licensed health care practitioner. 
103         4. Development, implementation, and ongoing evaluation of 
104  procedures, protocols, and systems to accurately identify 
105  patients, planned procedures, and the correct site of the 
106  planned procedure so as to minimize the performance of a 
107  surgical procedure on the wrong patient, a wrong surgical 
108  procedure, a wrong-site surgical procedure, or a surgical 
109  procedure otherwise unrelated to the patient’s diagnosis or 
110  medical condition. 
111         (c) The analysis of patient grievances that relate to 
112  patient care and the quality of medical services. 
113         (d) A system for informing a patient or an individual 
114  identified pursuant to s. 765.401(1) that the patient was the 
115  subject of an adverse incident, as defined in subsection (5). 
116  Such notice shall be given by an appropriately trained person 
117  designated by the licensed facility as soon as practicable to 
118  allow the patient an opportunity to minimize damage or injury. 
119  Documentation of the notification should be maintained by the 
120  facility. 
121         (e) The development and implementation of a an incident 
122  reporting system based upon the affirmative duty of all health 
123  care providers and all agents and employees of the licensed 
124  health care facility to report adverse incidents to the risk 
125  manager, or to his or her designee, within 3 business days after 
126  their occurrence. 
127         (2) The internal risk management program is the 
128  responsibility of the governing board of the health care 
129  facility. Each licensed facility shall hire a risk manager, 
130  licensed under s. 395.10974, who is responsible for 
131  implementation and oversight of the such facility’s internal 
132  risk management program as required by this section. 
133         (a) A risk manager may must not be made responsible for 
134  more than four internal risk management programs in separate 
135  licensed facilities, unless the facilities are under one 
136  corporate ownership or the risk management programs are in rural 
137  hospitals. 
138         (3) In addition to the programs mandated by this section, 
139  other innovative approaches intended to reduce the frequency and 
140  severity of medical malpractice and patient injury claims shall 
141  be encouraged and their implementation and operation 
142  facilitated. Such additional approaches may include extending 
143  internal risk management programs to health care providers’ 
144  offices and the assuming of provider liability by a licensed 
145  health care facility for acts or omissions occurring within the 
146  licensed facility. Each licensed facility shall annually report 
147  to the agency and the Department of Health the name and 
148  judgments entered against each health care practitioner for 
149  which it assumes liability. The agency and Department of Health, 
150  in their respective annual reports, shall include statistics 
151  that report the number of licensed facilities that assume such 
152  liability and the number of health care practitioners, by 
153  profession, for whom they assume liability. 
154         (4) The agency shall adopt rules governing the 
155  establishment of internal risk management programs to meet the 
156  needs of individual licensed facilities. Each internal risk 
157  management program shall include the use of incident reports to 
158  be filed with an individual of responsibility who is competent 
159  in risk management techniques in the employ of each licensed 
160  facility, such as an insurance coordinator, or who is retained 
161  by the licensed facility as a consultant. 
162         (b) The risk manager individual responsible for the risk 
163  management program shall have free access to all medical records 
164  of the licensed facility. 
165         (3) The incident Reports of adverse incidents are part of 
166  the workpapers of the attorney defending the licensed facility 
167  in litigation relating to the licensed facility and are subject 
168  to discovery, but are not admissible as evidence in court. A 
169  person filing an incident report is not subject to civil suit by 
170  virtue of such incident report. As a part of each internal risk 
171  management program, the incident reports shall be used to 
172  develop categories of incidents which identify problem areas. 
173  Once identified, procedures shall be adjusted to correct the 
174  problem areas. 
175         (4) For an incident to be an adverse incident that must be 
176  reported to the agency pursuant to this section, it must be: of 
177  concern to both the public and health care practitioners and 
178  providers; clearly identifiable and measurable and thus feasible 
179  to include in a reporting system; and of such a nature that the 
180  risk of occurrence is significantly influenced by the policies 
181  and procedures of the licensed facility. In addition, the 
182  incident must be unambiguous, usually preventable, serious, and 
183  any of the following: adverse; indicative of a problem in the 
184  facility’s safety systems; or important for public credibility 
185  or public accountability. The incident must also be on the most 
186  current list set forth by the National Quality Forum. 
187         (5)� Adverse incidents shall be reported electronically by 
188  the facility through an online portal to the agency within 15 
189  calendar days after the occurrence. The agency may grant an 
190  extension to this reporting requirement upon receiving 
191  justification submitted by the facility administrator to the 
192  agency. 
193         (a) An adverse incident listing an individual licensed by 
194  the Department of Health as directly involved in the incident 
195  must be immediately forwarded to the Department of Health and is 
196  subject to s. 456.073. 
197         (b) The reports are exempt from disclosure under chapter 
198  119 or any other law providing access to public records; not 
199  discoverable or admissible in any civil or administrative 
200  action, except in disciplinary proceedings by the Department of 
201  Health or the appropriate regulatory authority; and are not 
202  available to the public as part of the record of investigation 
203  for and prosecution in disciplinary proceedings ordinarily made 
204  available to the public. 
205         (c) The facility’s chief executive officer, or designee, 
206  shall certify quarterly, through the electronic submission 
207  portal, that all adverse incidents from the previous quarter 
208  have been reported and that the reports are accurate. 
209         (6) Within 60 days after the occurrence of an adverse 
210  incident, the agency shall require the facility to 
211  electronically submit a final report. The final report should 
212  include a copy of the root-cause analysis, any risk management 
213  or patient safety lessons learned, the plan of correction, and 
214  the results obtained during the plan’s implementation in the 
215  facility. The agency may investigate adverse incidents and 
216  prescribe measures that must or may be taken in response to the 
217  incident. These reports are exempt from disclosure under chapter 
218  119 or any other law providing access to public records, and are 
219  not discoverable or admissible in any civil or administrative 
220  action. 
221         (7) The agency shall publish on the agency’s website: 
222         (a) At least quarterly, a summary and trend analysis of 
223  adverse incidents received pursuant to this section, which does 
224  not include information that identifies the patient, the 
225  reporting facility, or the health care practitioners involved. 
226         (b) An annual report that describes and summarizes adverse 
227  incidents that have been submitted, and highlights patient 
228  safety lessons learned, common root-cause analysis findings, and 
229  notable corrective action plans implemented. 
230         (5) For purposes of reporting to the agency pursuant to 
231  this section, the term “adverse incident” means an event over 
232  which health care personnel could exercise control and which is 
233  associated in whole or in part with medical intervention, rather 
234  than the condition for which such intervention occurred, and 
235  which: 
236         (a) Results in one of the following injuries: 
237         1. Death; 
238         2. Brain or spinal damage; 
239         3. Permanent disfigurement; 
240         4. Fracture or dislocation of bones or joints; 
241         5. A resulting limitation of neurological, physical, or 
242  sensory function which continues after discharge from the 
243  facility; 
244         6. Any condition that required specialized medical 
245  attention or surgical intervention resulting from nonemergency 
246  medical intervention, other than an emergency medical condition, 
247  to which the patient has not given his or her informed consent; 
248  or 
249         7. Any condition that required the transfer of the patient, 
250  within or outside the facility, to a unit providing a more acute 
251  level of care due to the adverse incident, rather than the 
252  patient’s condition prior to the adverse incident; 
253         (b) Was the performance of a surgical procedure on the 
254  wrong patient, a wrong surgical procedure, a wrong-site surgical 
255  procedure, or a surgical procedure otherwise unrelated to the 
256  patient’s diagnosis or medical condition; 
257         (c) Required the surgical repair of damage resulting to a 
258  patient from a planned surgical procedure, where the damage was 
259  not a recognized specific risk, as disclosed to the patient and 
260  documented through the informed-consent process; or 
261         (d) Was a procedure to remove unplanned foreign objects 
262  remaining from a surgical procedure. 
263         (6)(a) Each licensed facility subject to this section shall 
264  submit an annual report to the agency summarizing the incident 
265  reports that have been filed in the facility for that year. The 
266  report shall include: 
267         1. The total number of adverse incidents. 
268         2. A listing, by category, of the types of operations, 
269  diagnostic or treatment procedures, or other actions causing the 
270  injuries, and the number of incidents occurring within each 
271  category. 
272         3. A listing, by category, of the types of injuries caused 
273  and the number of incidents occurring within each category. 
274         4. A code number using the health care professional’s 
275  licensure number and a separate code number identifying all 
276  other individuals directly involved in adverse incidents to 
277  patients, the relationship of the individual to the licensed 
278  facility, and the number of incidents in which each individual 
279  has been directly involved. Each licensed facility shall 
280  maintain names of the health care professionals and individuals 
281  identified by code numbers for purposes of this section. 
282         5. A description of all malpractice claims filed against 
283  the licensed facility, including the total number of pending and 
284  closed claims and the nature of the incident which led to, the 
285  persons involved in, and the status and disposition of each 
286  claim. Each report shall update status and disposition for all 
287  prior reports. 
288         (b) The information reported to the agency pursuant to 
289  paragraph (a) which relates to persons licensed under chapter 
290  458, chapter 459, chapter 461, or chapter 466 shall be reviewed 
291  by the agency. The agency shall determine whether any of the 
292  incidents potentially involved conduct by a health care 
293  professional who is subject to disciplinary action, in which 
294  case the provisions of s. 456.073 shall apply. 
295         (c) The report submitted to the agency shall also contain 
296  the name and license number of the risk manager of the licensed 
297  facility, a copy of its policy and procedures which govern the 
298  measures taken by the facility and its risk manager to reduce 
299  the risk of injuries and adverse incidents, and the results of 
300  such measures. The annual report is confidential and is not 
301  available to the public pursuant to s. 119.07(1) or any other 
302  law providing access to public records. The annual report is not 
303  discoverable or admissible in any civil or administrative 
304  action, except in disciplinary proceedings by the agency or the 
305  appropriate regulatory board. The annual report is not available 
306  to the public as part of the record of investigation for and 
307  prosecution in disciplinary proceedings made available to the 
308  public by the agency or the appropriate regulatory board. 
309  However, the agency or the appropriate regulatory board shall 
310  make available, upon written request by a health care 
311  professional against whom probable cause has been found, any 
312  such records which form the basis of the determination of 
313  probable cause. 
314         (7) Any of the following adverse incidents, whether 
315  occurring in the licensed facility or arising from health care 
316  prior to admission in the licensed facility, shall be reported 
317  by the facility to the agency within 15 calendar days after its 
318  occurrence: 
319         (a) The death of a patient; 
320         (b) Brain or spinal damage to a patient; 
321         (c) The performance of a surgical procedure on the wrong 
322  patient; 
323         (d) The performance of a wrong-site surgical procedure; 
324         (e) The performance of a wrong surgical procedure; 
325         (f) The performance of a surgical procedure that is 
326  medically unnecessary or otherwise unrelated to the patient’s 
327  diagnosis or medical condition; 
328         (g) The surgical repair of damage resulting to a patient 
329  from a planned surgical procedure, where the damage is not a 
330  recognized specific risk, as disclosed to the patient and 
331  documented through the informed-consent process; or 
332         (h) The performance of procedures to remove unplanned 
333  foreign objects remaining from a surgical procedure. 
334 
335  The agency may grant extensions to this reporting requirement 
336  for more than 15 days upon justification submitted in writing by 
337  the facility administrator to the agency. The agency may require 
338  an additional, final report. These reports shall not be 
339  available to the public pursuant to s. 119.07(1) or any other 
340  law providing access to public records, nor be discoverable or 
341  admissible in any civil or administrative action, except in 
342  disciplinary proceedings by the agency or the appropriate 
343  regulatory board, nor shall they be available to the public as 
344  part of the record of investigation for and prosecution in 
345  disciplinary proceedings made available to the public by the 
346  agency or the appropriate regulatory board. However, the agency 
347  or the appropriate regulatory board shall make available, upon 
348  written request by a health care professional against whom 
349  probable cause has been found, any such records which form the 
350  basis of the determination of probable cause. The agency may 
351  investigate, as it deems appropriate, any such incident and 
352  prescribe measures that must or may be taken in response to the 
353  incident. The agency shall review each incident and determine 
354  whether it potentially involved conduct by the health care 
355  professional who is subject to disciplinary action, in which 
356  case the provisions of s. 456.073 shall apply. 
357         (8) The agency shall publish on the agency’s website, no 
358  less than quarterly, a summary and trend analysis of adverse 
359  incident reports received pursuant to this section, which shall 
360  not include information that would identify the patient, the 
361  reporting facility, or the health care practitioners involved. 
362  The agency shall publish on the agency’s website an annual 
363  summary and trend analysis of all adverse incident reports and 
364  malpractice claims information provided by facilities in their 
365  annual reports, which shall not include information that would 
366  identify the patient, the reporting facility, or the 
367  practitioners involved. The purpose of the publication of the 
368  summary and trend analysis is to promote the rapid dissemination 
369  of information relating to adverse incidents and malpractice 
370  claims to assist in avoidance of similar incidents and reduce 
371  morbidity and mortality. 
372         (8)(9) The internal risk manager of each licensed facility 
373  shall: 
374         (a) Investigate every allegation of sexual misconduct which 
375  is made against a member of the facility’s personnel who has 
376  direct patient contact if, when the allegation is that the 
377  sexual misconduct occurred at the facility or on the grounds of 
378  the facility. 
379         (b) Report every allegation of sexual misconduct to the 
380  administrator of the licensed facility. 
381         (c) Notify the family or guardian of the victim, if a 
382  minor, that an allegation of sexual misconduct has been made and 
383  that an investigation is being conducted. 
384         (d) Report to the Department of Health every allegation of 
385  sexual misconduct, as defined in chapter 456 and the respective 
386  practice act, by a licensed health care practitioner which that 
387  involves a patient. 
388         (9)(10) Any witness who witnessed or who possesses actual 
389  knowledge of the act that is the basis of an allegation of 
390  sexual abuse shall: 
391         (a) Notify the local police; and 
392         (b) Notify the licensed facility’s hospital risk manager 
393  and the administrator. 
394 
395  For purposes of this subsection, “sexual abuse” means acts of a 
396  sexual nature committed for the sexual gratification of anyone 
397  upon, or in the presence of, a vulnerable adult, without the 
398  vulnerable adult’s informed consent, or a minor. The term 
399  “Sexual abuse” includes, but is not limited to, the acts defined 
400  in s. 794.011(1)(h), fondling, exposure of a vulnerable adult’s 
401  or minor’s sexual organs, or the use of the vulnerable adult or 
402  minor to solicit for or engage in prostitution or sexual 
403  performance. The term “Sexual abuse” does not include any act 
404  intended for a valid medical purpose or any act that which may 
405  reasonably be construed to be a normal caregiving action. 
406         (10)(11) A person who, with malice or with intent to 
407  discredit or harm a licensed facility or any person, makes a 
408  false allegation of sexual misconduct against a member of a 
409  licensed facility’s personnel commits is guilty of a misdemeanor 
410  of the second degree, punishable as provided in s. 775.082 or s. 
411  775.083. 
412         (12) In addition to any penalty imposed pursuant to this 
413  section or part II of chapter 408, the agency shall require a 
414  written plan of correction from the facility. For a single 
415  incident or series of isolated incidents that are nonwillful 
416  violations of the reporting requirements of this section or part 
417  II of chapter 408, the agency shall first seek to obtain 
418  corrective action by the facility. If the correction is not 
419  demonstrated within the timeframe established by the agency or 
420  if there is a pattern of nonwillful violations of this section 
421  or part II of chapter 408, the agency may impose an 
422  administrative fine, not to exceed $5,000 for any violation of 
423  the reporting requirements of this section or part II of chapter 
424  408. The administrative fine for repeated nonwillful violations 
425  may not exceed $10,000 for any violation. The administrative 
426  fine for each intentional and willful violation may not exceed 
427  $25,000 per violation, per day. The fine for an intentional and 
428  willful violation of this section or part II of chapter 408 may 
429  not exceed $250,000. In determining the amount of fine to be 
430  levied, the agency shall be guided by s. 395.1065(2)(b). 
431         (11)(13) The agency shall have access to all licensed 
432  facility records necessary to carry out the provisions of this 
433  section. The records obtained by the agency under subsection (5) 
434  or subsection (6), subsection (7), or subsection (9) are exempt 
435  from disclosure not available to the public under s. 119.07(1), 
436  and are not nor shall they be discoverable or admissible in any 
437  civil or administrative action, except in disciplinary 
438  proceedings by the agency, the Department of Health, or the 
439  appropriate regulatory board., nor shall Records obtained 
440  pursuant to s. 456.071 may not be made available to the public 
441  as part of the record of investigation for and prosecution in 
442  disciplinary proceedings made available to the public by the 
443  agency or the appropriate regulatory board. However, the agency 
444  or the appropriate regulatory board shall make available, upon 
445  written request by a health care professional against whom 
446  probable cause has been found, any such records which form the 
447  basis of the determination of probable cause, except that, with 
448  respect to medical review committee records, s. 766.101 
449  controls. 
450         (12)(14) The meetings of the committees and governing board 
451  of a licensed facility held solely for the purpose of achieving 
452  the objectives of risk management purposes as provided by this 
453  section are shall not be open to the public pursuant to under 
454  the provisions of chapter 286. The records of such meetings are 
455  confidential and exempt from s. 119.07(1), except as provided in 
456  subsection (11) (13). 
457         (13)(15) The agency shall review, As part of its licensure 
458  inspection process, the agency shall review the internal risk 
459  management program of at each licensed facility regulated by 
460  this section to determine whether the program meets the 
461  standards established in statutes and rules, whether the program 
462  is being conducted in a manner designed to reduce adverse 
463  incidents, and whether the program is appropriately reporting 
464  such incidents under this section. 
465         (14)(16) There shall be No monetary liability on the part 
466  of, and no cause of action for damages shall arise against, any 
467  risk manager, licensed under s. 395.10974, for the 
468  implementation and oversight of the internal risk management 
469  program in a facility licensed under this chapter or chapter 390 
470  as required by this section, for any act or proceeding 
471  undertaken or performed within the scope of the functions of 
472  such internal risk management program if the risk manager acts 
473  without intentional fraud. 
474         (15)(17) A privilege against civil liability is hereby 
475  granted to any licensed risk manager or licensed facility with 
476  regard to information furnished pursuant to this chapter, unless 
477  the licensed risk manager or facility acted in bad faith or with 
478  malice in providing such information. 
479         (18) If the agency, through its receipt of any reports 
480  required under this section or through any investigation, has a 
481  reasonable belief that conduct by a staff member or employee of 
482  a licensed facility is grounds for disciplinary action by the 
483  appropriate regulatory board, the agency shall report this fact 
484  to such regulatory board. 
485         (16)(19) No It shall be unlawful for any person may to 
486  coerce, intimidate, or preclude a risk manager from lawfully 
487  executing his or her reporting obligations pursuant to this 
488  chapter. Such action is unlawful action shall be subject to 
489  civil monetary penalties not to exceed $10,000 per violation. 
490         (17) The agency may impose administrative fines on licensed 
491  facilities for violations of the reporting requirements of this 
492  section. In determining the amount of fine to be levied, the 
493  agency shall consider the factors listed in s. 395.1065(2)(b). 
494         (a) Before imposing a fine for a nonwillful violation, the 
495  agency shall first seek to obtain corrective action by the 
496  facility for a single incident or series of isolated incidents. 
497         (b) If the correction of a nonwillful violation is not 
498  accomplished within the timeframe established by the agency or 
499  if there is a pattern of nonwillful violations, the agency may 
500  impose an administrative fine of up to $5,000. However, the 
501  administrative fine for repeated nonwillful violations may not 
502  exceed $10,000. 
503         (c) The agency may impose an administrative fine of up to 
504  $25,000 per violation per day for each intentional and willful 
505  violation. However, the fine for an intentional and willful 
506  violation may not exceed $250,000. 
507         (18) The agency may adopt rules to administer this section. 
508         Section 2. Effective January 1, 2011, paragraph (e) of 
509  subsection (4) of section 395.3025, Florida Statutes, is amended 
510  to read: 
511         395.3025 Patient and personnel records; copies; 
512  examination.— 
513         (4) Patient records are confidential and must not be 
514  disclosed without the consent of the patient or his or her legal 
515  representative, but appropriate disclosure may be made without 
516  such consent to: 
517         (e) The Department of Health agency upon issuance of a 
518  subpoena issued pursuant to s. 456.071. However, but the records 
519  obtained thereby must be used solely by for the purpose of the 
520  department agency and the appropriate regulatory professional 
521  board in its investigation, prosecution, and appeal of 
522  disciplinary proceedings. If the department agency requests 
523  copies of the records, the facility may not shall charge no more 
524  than its actual copying costs, including reasonable staff time. 
525  The records must be sealed and may must not be made available to 
526  the public pursuant to s. 119.07(1) or any other statute 
527  providing access to records, and may not be made nor may they be 
528  available to the public as part of the record of investigation 
529  for and prosecution in disciplinary proceedings made available 
530  to the public by the department agency or the appropriate 
531  regulatory board. However, the department agency must make 
532  available, upon written request by a practitioner against whom 
533  probable cause has been found, any such records that form the 
534  basis of the determination of probable cause. 
535         Section 3. Subsections (2) and (14) of section 400.462, 
536  Florida Statutes, are amended, present subsections (27) through 
537  (29) of that section are renumbered as subsections (28) through 
538  (30), respectively, and new subsections (27) and (31) are added 
539  to that section, to read: 
540         400.462 Definitions.—As used in this part, the term: 
541         (2) “Admission” means a decision by the home health agency, 
542  during or after an evaluation visit with the patient to the 
543  patient’s home, that there is reasonable expectation that the 
544  patient’s medical, nursing, and social needs for skilled care 
545  can be adequately met by the agency in the patient’s place of 
546  residence. Admission includes completion of an agreement with 
547  the patient or the patient’s legal representative to provide 
548  home health services as required in s. 400.487(1). 
549         (14) “Home health services” means health and medical 
550  services and medical supplies furnished by an organization to an 
551  individual in the individual’s home or place of residence. The 
552  term includes organizations that provide one or more of the 
553  following: 
554         (a) Nursing care. 
555         (b) Physical, occupational, respiratory, or speech therapy. 
556         (c) Home health aide services. 
557         (d) Dietetics and nutrition practice and nutrition 
558  counseling. 
559         (e) Medical supplies and durable medical equipment, 
560  restricted to drugs and biologicals prescribed by a physician. 
561         (27) “Primary home health agency” means the agency 
562  responsible for the services furnished to patients and for 
563  implementation of the plan of care. 
564         (28)(27) “Remuneration” means any payment or other benefit 
565  made directly or indirectly, overtly or covertly, in cash or in 
566  kind. 
567         (29)(28) “Skilled care” means nursing services or 
568  therapeutic services required by law to be delivered by a health 
569  care professional who is licensed under part I of chapter 464; 
570  part I, part III, or part V of chapter 468; or chapter 486 and 
571  who is employed by or under contract with a licensed home health 
572  agency or is referred by a licensed nurse registry. 
573         (30)(29) “Staffing services” means services provided to a 
574  health care facility, school, or other business entity on a 
575  temporary or school-year basis pursuant to a written contract by 
576  licensed health care personnel and by certified nursing 
577  assistants and home health aides who are employed by, or work 
578  under the auspices of, a licensed home health agency or who are 
579  registered with a licensed nurse registry. 
580         (31) “Temporary” means employment provided on an interim 
581  basis, such as for employee absences, during short-term skill 
582  shortages, or due to seasonal workloads. 
583         Section 4. Section 400.476, Florida Statutes, is amended to 
584  read: 
585         400.476 Staffing requirements; notifications; limitations 
586  on staffing services.— 
587         (1) ADMINISTRATOR.— 
588         (a) An administrator may manage only one home health 
589  agency, except that an administrator may manage up to five home 
590  health agencies if all five home health agencies have identical 
591  controlling interests as defined in s. 408.803 and are located 
592  within one agency geographic service area or within an 
593  immediately contiguous county. If the home health agency is 
594  licensed under this chapter and is part of a retirement 
595  community that provides multiple levels of care, an employee of 
596  the retirement community may administer the home health agency 
597  and up to a maximum of four entities licensed under this chapter 
598  or chapter 429 which all have identical controlling interests as 
599  defined in s. 408.803. An administrator shall designate, in 
600  writing, for each licensed entity, a qualified alternate 
601  administrator to serve during the administrator’s absence. An 
602  alternate administrator must meet the same standards as an 
603  administrator as defined in s. 400.462 and is subject to the 
604  same limitations under this paragraph. 
605         (b) An administrator of a home health agency who is a 
606  licensed physician, physician assistant, or registered nurse 
607  licensed to practice in this state may also be the director of 
608  nursing for a home health agency. An administrator may serve as 
609  a director of nursing for up to the number of entities 
610  authorized in subsection (2) only if there are 10 or fewer full 
611  time equivalent employees and contracted personnel in each home 
612  health agency. 
613         (2) DIRECTOR OF NURSING.— 
614         (a) A director of nursing may be the director of nursing 
615  for: 
616         1. Up to two licensed home health agencies if the agencies 
617  have identical controlling interests as defined in s. 408.803 
618  and are located within one agency geographic service area or 
619  within an immediately contiguous county; or 
620         2. Up to five licensed home health agencies if: 
621         a. All of the home health agencies have identical 
622  controlling interests as defined in s. 408.803; 
623         b. All of the home health agencies are located within one 
624  agency geographic service area or within an immediately 
625  contiguous county; and 
626         c. Each home health agency has a registered nurse who meets 
627  the qualifications of a director of nursing and who has a 
628  written delegation from the director of nursing to serve as the 
629  director of nursing for that home health agency when the 
630  director of nursing is not present. 
631 
632  If a home health agency licensed under this chapter is part of a 
633  retirement community that provides multiple levels of care, an 
634  employee of the retirement community may serve as the director 
635  of nursing of the home health agency and up to a maximum of four 
636  entities, other than home health agencies, licensed under this 
637  chapter or chapter 429 which all have identical controlling 
638  interests as defined in s. 408.803. 
639         (b) A home health agency that provides skilled nursing care 
640  may not operate for more than 30 calendar days without a 
641  director of nursing. The A home health agency that provides 
642  skilled nursing care and the director of nursing of a home 
643  health agency must notify the agency within 10 business days 
644  after termination of the services of the director of nursing for 
645  the home health agency. The A home health agency that provides 
646  skilled nursing care must notify the agency of the identity and 
647  qualifications of the new director of nursing within 10 days 
648  after the new director is hired. 
649         1. If A home health agency that provides skilled nursing 
650  care and that operates for more than 30 calendar days without a 
651  director of nursing, the home health agency commits a class II 
652  deficiency. In addition to the fine for a class II deficiency, 
653  the agency may issue a moratorium in accordance with s. 408.814 
654  or revoke the home health agency’s license. The agency shall 
655  fine a home health agency that fails to notify the agency as 
656  required in this paragraph $1,000 for the first violation and 
657  $2,000 for a repeat violation. The agency may not take 
658  administrative action against a home health agency if the 
659  director of nursing fails to notify the department upon 
660  termination of services as the director of nursing for the home 
661  health agency. 
662         2.(c) A home health agency that is not Medicare or Medicaid 
663  certified and does not provide skilled care or provides only 
664  physical, occupational, or speech therapy is not required to 
665  have a director of nursing and is exempt from this paragraph 
666  (b). 
667         (3) TRAINING.—A home health agency shall ensure that each 
668  certified nursing assistant employed by or under contract with 
669  the home health agency and each home health aide employed by or 
670  under contract with the home health agency is adequately trained 
671  to perform the tasks of a home health aide in the home setting. 
672         (a) Only home health aides who have successfully completed 
673  a home health aide training and competency test as provided 
674  under s. 400.497 may be used by the home health agency to 
675  provide home health aide services whether on a full-time, 
676  temporary, per diem, or other basis. A home health aide is not 
677  considered to have successfully passed a competency test if the 
678  aide does not have a passing score as specified in rule. 
679         (b) If a home health aide has been evaluated as 
680  “unsatisfactory” in conducting a particular task during a 
681  competency test, the aide may not perform that task without 
682  being directly supervised by a licensed nurse until the aide 
683  receives training in that task and is subsequently evaluated as 
684  “satisfactory.” 
685         (4) HOME HEALTH AGENCY PERSONNEL.— 
686         (a) At least one home health agency service must be 
687  provided directly by home health agency employees. However, 
688  additional services may be provided under contract with another 
689  home health agency or organization. The contract must be in 
690  writing and, at a minimum, must specify the following: 
691         1. That patients are accepted for care only by the primary 
692  home health agency. 
693         2. The home health services to be furnished by the 
694  contracted personnel. 
695         3. The necessity for the contracted personnel to conform to 
696  all applicable agency policies, including practitioner 
697  qualifications and standards of practice. 
698         4. The responsibility of the contracted personnel to 
699  participate in developing plans of care. 
700         5. The manner in which the provision of home health 
701  services will be controlled, coordinated, and evaluated by the 
702  primary home health agency. 
703         6. The procedures for contracted personnel to submit 
704  clinical and progress notes, schedules of visits, and periodic 
705  patient evaluations. 
706         7. The procedures for payment for services furnished by the 
707  contracted personnel. 
708         (b) If the home health agency contracts with home health 
709  agency personnel on an hourly or per-visit basis, the home 
710  health agency must have a written contract with such personnel 
711  which conforms to the contractual requirements specified in 
712  paragraph (a). 
713         (c) If home health aide services are provided by an 
714  individual who is not directly employed by the home health 
715  agency, the services of the aide must be provided under written 
716  contract as provided in paragraphs (a) and (b). If the home 
717  health agency contracts with another organization for the 
718  provision of home health aide services, at a minimum, the home 
719  health agency is responsible for: 
720         1. Ensuring the overall quality of the care provided by the 
721  aide; 
722         2. Overseeing the services provided by the home health aide 
723  as described in s. 400.487; and 
724         3. Ensuring that the home health aides have met the 
725  training requirements or competency test requirements of s. 
726  400.497. 
727         (5)(4) STAFFING.—Staffing services may be provided anywhere 
728  within the state. 
729         Section 5. Section 400.4775, Florida Statutes, is created 
730  to read: 
731         400.4775 Personnel duties.—The home health agency and its 
732  staff must comply with all professional standards and principles 
733  that apply to health care practitioners providing services in a 
734  home health agency setting, including, but not limited to, state 
735  practice acts and the home health agency’s policies and 
736  procedures. All home health agency personnel must ensure that 
737  services furnished are effectively coordinated and support the 
738  objectives outlined in the patient’s plan of care. The clinical 
739  record or minutes of case conferences must document that 
740  effective interchange, reporting, and coordination of patient 
741  care occurs. 
742         (1) ADMINISTRATOR.— 
743         (a) The duties of an administrator include organizing and 
744  directing the agency’s ongoing functions; maintaining an ongoing 
745  liaison with the board members and the staff; employing 
746  qualified personnel and ensuring adequate staff education and 
747  evaluations; ensuring the accuracy of public information 
748  materials and activities; implementing an effective budgeting 
749  and accounting system; and ensuring that the home health agency 
750  operates in compliance with this part and chapter 408, part II 
751  of this chapter, and rules adopted pursuant to those laws. 
752         (b) Administrator duties relating to organization, services 
753  furnished, administrative control, and lines of authority for 
754  the delegation of responsibility down to the patient care level 
755  must be clearly set forth in writing and be readily 
756  identifiable. Administrative and supervisory functions may not 
757  be delegated to another agency or organization, and all services 
758  not furnished directly, including services provided through 
759  contracts, must be monitored and controlled by the primary home 
760  health agency. 
761         (2) DIRECTOR OF NURSING.—The director of nursing, or a 
762  similarly qualified alternate, must be available at all times 
763  during operating hours and participate in all activities 
764  relevant to the professional services furnished, including, but 
765  not limited to, the oversight of nursing services, home health 
766  aides, and certified nursing assistants and the assignment of 
767  personnel. 
768         (3) NURSING SERVICES.— 
769         (a) The registered nurse shall make the initial evaluation 
770  visit, regularly reevaluate the patient’s nursing needs, 
771  initiate the plan of care and necessary revisions, furnish those 
772  services requiring substantial and specialized nursing skill, 
773  initiate appropriate preventive and rehabilitative nursing 
774  procedures, prepare clinical and progress notes, coordinate 
775  services, inform the physician and other personnel of changes in 
776  the patient’s condition and needs, counsel the patient and 
777  family in meeting nursing and related needs, participate in in 
778  service programs, and supervise and teach other nursing 
779  personnel. 
780         (b) The licensed practical nurse shall furnish services in 
781  accordance with agency policies, prepare clinical and progress 
782  notes, assist the physician and registered nurse in performing 
783  specialized procedures, prepare equipment and materials for 
784  treatments observing aseptic technique as required, and assist 
785  the patient in learning appropriate self-care techniques. 
786         (4) THERAPY SERVICES.— 
787         (a) Any physical or occupational therapy services offered 
788  by the home health agency, directly or under contract, must be 
789  provided by an appropriately licensed therapist or therapy 
790  assistant and in accordance with the plan of care. The therapist 
791  and therapy assistant must meet all professional qualifications 
792  specified in their respective state practice acts and related 
793  rules. 
794         1. A physical or occupational therapist assists the 
795  physician in evaluating level of function, helps develop and 
796  revise the plan of care, prepares clinical and progress notes, 
797  advises and consults with the family and other agency personnel, 
798  and participates in in-service programs. 
799         2. A physical or occupational therapy assistant performs 
800  services that are planned, delegated, and supervised by a 
801  physical or occupational therapist; assists in preparing 
802  clinical notes and progress reports; participates in educating 
803  the patient and family; and participates in in-service programs. 
804         (b) Speech therapy services shall be furnished only by or 
805  under the supervision of a qualified speech pathologist or 
806  audiologist as required in the state practice act and related 
807  rules. 
808         (5) HOME HEALTH AIDES AND CERTIFIED NURSING ASSISTANTS. 
809  Home health aides and certified nursing assistants provide 
810  services that are ordered by the physician in the plan of care 
811  and that the home health aide is permitted to perform under 
812  state law. 
813         (a) The duties of a home health aide and certified nursing 
814  assistant include the provision of hands-on personal care, 
815  performance of simple procedures as an extension of therapy or 
816  nursing services, assistance in ambulation or exercises, and 
817  assistance in administering medications that are ordinarily 
818  self-administered and as specified in state rules. Any home 
819  health aide services offered by a home health agency must be 
820  provided by a qualified home health aide or certified nursing 
821  assistant. 
822         (b) The home health aide and certified nursing assistant 
823  shall be assigned to a specific patient by the registered nurse. 
824  Written patient care instructions for the home health aide and 
825  certified nursing assistant must be prepared by the registered 
826  nurse or other appropriate professional who is responsible for 
827  the supervision of the home health aide and certified nursing 
828  assistant. 
829         Section 6. Section 400.487, Florida Statutes, is amended to 
830  read: 
831         400.487 Home health service agreements; physician’s, 
832  physician assistant’s, and advanced registered nurse 
833  practitioner’s treatment orders; patient assessment; 
834  establishment and review of plan of care; provision of services; 
835  orders not to resuscitate.— 
836         (1) Services provided by a home health agency must be 
837  covered by an agreement between the home health agency and the 
838  patient or the patient’s legal representative specifying the 
839  home health services to be provided, the rates or charges for 
840  services paid with private funds, and the sources of payment, 
841  which may include Medicare, Medicaid, private insurance, 
842  personal funds, or a combination thereof. A copy of the 
843  agreement must be provided to the patient or the patient’s legal 
844  representative. A home health agency providing skilled care must 
845  make an assessment of the patient’s needs within 48 hours after 
846  the start of services. 
847         (2) If When required by the provisions of chapter 464; part 
848  I, part III, or part V of chapter 468; or chapter 486, the 
849  attending physician, physician assistant, or advanced registered 
850  nurse practitioner, acting within his or her respective scope of 
851  practice, shall establish treatment orders for a patient who is 
852  to receive skilled care. The treatment orders must be signed by 
853  the physician, physician assistant, or advanced registered nurse 
854  practitioner before a claim for payment for the skilled services 
855  is submitted by the home health agency. If the claim is 
856  submitted to a managed care organization, the treatment orders 
857  must be signed within the time allowed under the provider 
858  agreement. The treatment orders shall be reviewed, as frequently 
859  as the patient’s illness requires, by the physician, physician 
860  assistant, or advanced registered nurse practitioner in 
861  consultation with the home health agency. 
862         (3) Home health care and treatment must follow a written 
863  plan of care. The plan of care must be reviewed by the attending 
864  physician, physician assistant, or advanced registered nurse 
865  practitioner who provided treatment orders under subsection (2) 
866  and home health agency personnel as often as the severity of the 
867  patient’s condition requires, but at least once every 60 days or 
868  more frequently if there is a patient-elected transfer, a 
869  significant change in condition resulting in a change in the 
870  personnel assignment, or a discharge and return to the same home 
871  health agency during the 60-day time period. Home health agency 
872  professional staff must promptly alert the physician or other 
873  professional who provided treatment orders to any changes that 
874  suggest a need to alter the plan of care. A home health agency 
875  shall arrange for supervisory visits by a registered nurse to 
876  the home of a patient receiving home health aide services in 
877  accordance with the patient’s direction, approval, and agreement 
878  to pay the charge for the visits. 
879         (4) Each patient has the right to be informed of and to 
880  participate in the planning of his or her care. Each patient 
881  must be provided, upon request, a copy of the plan of care 
882  established and maintained for that patient by the primary home 
883  health agency. 
884         (5) If When nursing services are ordered, the home health 
885  agency to which a patient has been admitted for care must 
886  provide the initial admission visit, all service evaluation 
887  visits, and the discharge visit by a direct employee. Services 
888  provided by others under contractual arrangements to a home 
889  health agency must be monitored and managed by the admitting 
890  home health agency. The admitting home health agency is fully 
891  responsible for ensuring that all care provided through its 
892  employees or contract staff is delivered in accordance with this 
893  part and applicable rules. 
894         (6) The skilled care services provided by a home health 
895  agency, directly or under contract, must be supervised and 
896  coordinated in accordance with the plan of care and must be 
897  provided by or under the supervision of a registered nurse. 
898         (a) If the patient receives skilled nursing care, the 
899  registered nurse must perform the supervisory visit. The 
900  registered nurse or other professional must make an on-site 
901  visit to the patient’s home at least every 2 weeks. The visit 
902  need not occur when the home health aide is providing care. 
903         (b) If home health aide services are provided to a patient 
904  who is not receiving skilled nursing care, physical or 
905  occupational therapy, or speech-language pathology services, the 
906  registered nurse must make a supervisory visit to the patient’s 
907  home at least every 60 days. To ensure that the home health aide 
908  is properly caring for the patient, each supervisory visit must 
909  occur while the home health aide is providing patient care. 
910         (7) Drugs and treatments may be administered by agency 
911  staff only pursuant to treatment orders with the exception of 
912  influenza and pneumococcal polysaccharide vaccines, which may be 
913  administered pursuant to the home health agency’s policy 
914  developed in consultation with a physician, and after an 
915  assessment for contraindications. Verbal orders must be put in 
916  writing and signed and dated with the date of receipt by the 
917  registered nurse or therapist responsible for furnishing or 
918  supervising the ordered services. Verbal orders may be accepted 
919  only by personnel authorized to do so by applicable state 
920  practice acts and applicable rules as well as pursuant to the 
921  home health agency’s policies. 
922         (8)(7) Home health agency personnel may withhold or 
923  withdraw cardiopulmonary resuscitation if presented with an 
924  order not to resuscitate executed pursuant to s. 401.45. The 
925  agency shall adopt rules providing for the implementation of 
926  such orders. Home health personnel and agencies shall not be 
927  subject to criminal prosecution or civil liability, nor be 
928  considered to have engaged in negligent or unprofessional 
929  conduct, for withholding or withdrawing cardiopulmonary 
930  resuscitation pursuant to such an order and rules adopted by the 
931  agency. 
932         Section 7. Section 400.493, Florida Statutes, is created to 
933  read: 
934         400.493 Patient rights.— 
935         (1) The home health agency must protect and promote the 
936  rights of each patient under its care, including each of the 
937  following: 
938         (a) The patient has the right to participate in the 
939  provision of his or her care. The home health agency must advise 
940  the patient in advance of the right to participate in planning 
941  his or her care or treatment and in any changes to that plan. 
942  The home health agency must advise the patient in advance of any 
943  change in the plan of care before the change is made. 
944         (b) The patient has the right to be informed about the care 
945  to be provided and any changes in the furnishing of that care. 
946  The home health agency must inform the patient in advance about 
947  the care and treatment to be furnished and any changes in the 
948  care and treatment. The home health agency must advise the 
949  patient of which practitioners will be furnishing care and the 
950  proposed frequency of their visits. 
951         (c) The patient has the right to have his or her property 
952  treated with respect. 
953         (d) The patient has the right to exercise his or her rights 
954  as a patient of the home health agency, including the right to 
955  voice grievances regarding the violations of those rights. The 
956  patient may not be subjected to discrimination or reprisal for 
957  voicing such grievances. 
958         (2) The patient and his or her immediate family or 
959  representative must be informed of the right to report 
960  complaints to the statewide toll-free telephone number as 
961  required under s. 408.810(5). 
962         (3) The home health agency must investigate complaints made 
963  by a patient, or the patient’s family or guardian on behalf of 
964  the patient, pursuant to this section, and must document both 
965  the existence of the complaint and the resolution of the 
966  complaint. 
967         (4) The home health agency must provide the patient with a 
968  written notice of the patient’s rights in advance of furnishing 
969  care to the patient or during the initial evaluation visit 
970  before the initiation of treatment. The home health agency must 
971  maintain documentation showing that it has complied with this 
972  subsection. 
973         Section 8. Subsection (2) of section 400.933, Florida 
974  Statutes, is amended to read: 
975         400.933 Licensure inspections and investigations.— 
976         (2) The agency shall accept, In lieu of its own periodic 
977  inspections for licensure, the agency shall accept submission of 
978  the following: 
979         (a) The survey or inspection of an accrediting organization 
980  if, provided the accreditation of the licensed home medical 
981  equipment provider is not conditional or provisional and 
982  provided the licensed home medical equipment provider authorizes 
983  the release of, and the agency receives the report of, the 
984  accrediting organization.; or 
985         (b) A copy of a valid medical oxygen retail establishment 
986  permit issued by the Department of Health, pursuant to chapter 
987  499. 
988         Section 9. Subsection (1) of section 400.969, Florida 
989  Statutes, is amended to read: 
990         400.969 Violation of part; penalties.— 
991         (1) In addition to the requirements of part II of chapter 
992  408, and except as provided in s. 400.967(3), a violation of any 
993  provision of federal certification required pursuant to s. 
994  400.960(8), this part, part II of chapter 408, or applicable 
995  rules is punishable by payment of an administrative or civil 
996  penalty not to exceed $5,000. 
997         Section 10. Effective January 1, 2011, subsections (1) and 
998  (2) of section 408.05, Florida Statutes, are amended to read: 
999         408.05 Florida Center for Health Information and Policy 
1000  Analysis.— 
1001         (1) ESTABLISHMENT.—The agency shall establish a Florida 
1002  Center for Health Information and Policy Analysis. The center 
1003  shall establish a comprehensive health information system to 
1004  provide for the collection, compilation, coordination, analysis, 
1005  indexing, dissemination, and use of utilization of both 
1006  purposefully collected and extant health-related data and 
1007  statistics. The center shall be staffed with public health 
1008  experts, biostatisticians, information system analysts, health 
1009  policy experts, risk management experts, economists, and other 
1010  staff necessary to carry out its functions. 
1011         (2) HEALTH-RELATED DATA.—The comprehensive health 
1012  information system operated by the Florida center must for 
1013  Health Information and Policy Analysis shall identify the best 
1014  available data sources, and coordinate the compilation of extant 
1015  health-related data and statistics, and purposefully collect 
1016  data on: 
1017         (a) The extent and nature of illness and disability of the 
1018  state population, including life expectancy, the incidence of 
1019  various acute and chronic illnesses, and infant and maternal 
1020  morbidity and mortality. 
1021         (b) The impact of illness and disability of the state 
1022  population on the state economy and on other aspects of the 
1023  well-being of the people in this state. 
1024         (c) Environmental, social, and other health hazards. 
1025         (d) Health knowledge and practices of state residents the 
1026  people in this state and determinants of health and nutritional 
1027  practices and status. 
1028         (e) Health resources, including physicians, dentists, 
1029  nurses, and other health professionals, by specialty and type of 
1030  practice and acute, long-term care and other institutional care 
1031  facility supplies and specific services provided by hospitals, 
1032  nursing homes, home health agencies, and other health care 
1033  facilities. 
1034         (f) Utilization of health care by type of provider. 
1035         (g) Health care costs and financing, including trends in 
1036  health care prices and costs, the sources of payment for health 
1037  care services, and federal, state, and local expenditures for 
1038  health care. 
1039         (h) Family formation, growth, and dissolution. 
1040         (i) The extent of public and private health insurance 
1041  coverage in this state. 
1042         (j) The quality of care provided by various health care 
1043  providers. 
1044         (k) Patient safety in health facilities. The center is 
1045  responsible for collecting and analyzing adverse incidents 
1046  submitted by licensed facilities and certified organizations 
1047  under ss. 395.0197 and 641.55. Such incidents may be reviewed 
1048  for accuracy, completeness, and compliance. The center is also 
1049  responsible for the agency’s reporting requirements under s. 
1050  395.0197. 
1051         Section 11. Paragraph (b) of subsection (14) of section 
1052  408.7056, Florida Statutes, is amended to read: 
1053         408.7056 Subscriber Assistance Program.— 
1054         (14) 
1055         (b) Meetings of the panel are shall be open to the public 
1056  unless the provider or subscriber whose grievance will be heard 
1057  requests a closed meeting or the agency or the department 
1058  determines that information that which discloses the 
1059  subscriber’s medical treatment or history or information 
1060  relating to internal risk management programs as provided in s. 
1061  641.55 defined in s. 641.55(5)(c), (6), and (8) may be revealed 
1062  at the panel meeting, in which case that portion of the meeting 
1063  during which a subscriber’s medical treatment or history or 
1064  internal risk management program information is discussed is 
1065  shall be exempt from the provisions of s. 286.011 and s. 24(b), 
1066  Art. I of the State Constitution. All closed meetings shall be 
1067  recorded by a certified court reporter. 
1068         Section 12. Section 408.805, Florida Statutes, is amended 
1069  to read: 
1070         408.805 Fees required; adjustments.—Unless otherwise 
1071  limited by authorizing statutes, License fees must be reasonably 
1072  calculated by the agency to cover its costs in carrying out its 
1073  responsibilities under this part, authorizing statutes, and 
1074  applicable rules, including the cost of licensure, inspection, 
1075  and regulation of providers. 
1076         (1) Licensure fees shall be adjusted to provide for 
1077  biennial licensure under agency rules. 
1078         (2) The agency shall annually adjust licensure fees, 
1079  including fees paid per bed, by not more than the change in the 
1080  Consumer Price Index based on the 12 months immediately 
1081  preceding the increase. 
1082         (3) An inspection fee must be paid as required in 
1083  authorizing statutes. 
1084         (4) Fees are nonrefundable. 
1085         (5) If When a change is reported which that requires 
1086  issuance of a license, a fee may be assessed. The fee must be 
1087  based on the actual cost of processing and issuing the license. 
1088         (6) A fee may be charged to a licensee requesting a 
1089  duplicate license. The fee may not exceed the actual cost of 
1090  duplication and postage. 
1091         (7) Total fees collected may not exceed the cost of 
1092  administering this part, authorizing statutes, and applicable 
1093  rules. 
1094         Section 13. Paragraph (a) of subsection (6) of section 
1095  408.811, Florida Statutes, is amended to read: 
1096         408.811 Right of inspection; copies; inspection reports; 
1097  plan for correction of deficiencies.— 
1098         (6)(a) Each licensee shall maintain as public information, 
1099  available upon request, records of all inspection reports 
1100  pertaining to that provider which that have been filed by the 
1101  agency unless those reports are exempt from or contain 
1102  information that is exempt from s. 119.07(1) and s. 24(a), Art. 
1103  I of the State Constitution or is otherwise made confidential by 
1104  law. Effective October 1, 2006, Copies of such reports shall be 
1105  retained in the records of the provider for at least 3 years 
1106  following the date the reports are filed and issued, regardless 
1107  of a change of ownership. Inspection reports are not subject to 
1108  challenge under s. 120.569 or s. 120.57. 
1109         Section 14. Subsections (2) and (11) of section 429.65, 
1110  Florida Statutes, are amended to read: 
1111         429.65 Definitions.—As used in this part, the term: 
1112         (2) “Adult family-care home” means a full-time, family-type 
1113  living arrangement, in a private home, under which one to two 
1114  individuals who reside in the home and own or rent the home 
1115  provide a person who owns or rents the home provides room, 
1116  board, and personal care, on a 24-hour basis, for no more than 
1117  five disabled adults or frail elders who are not relatives. The 
1118  following family-type living arrangements are not required to be 
1119  licensed as an adult family-care home: 
1120         (a) An arrangement whereby the person who resides in the 
1121  home and owns or rents the home provides room, board, and 
1122  personal care services for not more than two adults who do not 
1123  receive optional state supplementation under s. 409.212. The 
1124  person who provides the housing, meals, and personal care must 
1125  own or rent the home and reside therein. 
1126         (b) An arrangement whereby the person who owns or rents the 
1127  home provides room, board, and personal services only to his or 
1128  her relatives. 
1129         (c) An establishment that is licensed as an assisted living 
1130  facility under this chapter. 
1131         (11) “Provider” means the one or two individuals who are a 
1132  person who is licensed to operate an adult family-care home. 
1133         Section 15. Effective January 1, 2011, subsection (9) of 
1134  section 458.331, Florida Statutes, is amended to read: 
1135         458.331 Grounds for disciplinary action; action by the 
1136  board and department.— 
1137         (9) If When an investigation of a physician is undertaken, 
1138  the department shall promptly furnish to the physician or the 
1139  physician’s attorney a copy of the complaint or document that 
1140  which resulted in the initiation of the investigation. For 
1141  purposes of this subsection, such documents include, but are not 
1142  limited to: the pertinent portions of an annual report submitted 
1143  to the department pursuant to s. 395.0197(6); a report of an 
1144  adverse incident which is provided to the department pursuant to 
1145  s. 395.0197; a report of peer review disciplinary action 
1146  submitted to the department pursuant to s. 395.0193(4) or s. 
1147  458.337, if providing that the investigations, proceedings, and 
1148  records relating to such peer review disciplinary action shall 
1149  continue to retain their privileged status even as to the 
1150  licensee who is the subject of the investigation, as provided by 
1151  ss. 395.0193(8) and 458.337(3); a report of a closed claim 
1152  submitted pursuant to s. 627.912; a presuit notice submitted 
1153  pursuant to s. 766.106(2); and a petition brought under the 
1154  Florida Birth-Related Neurological Injury Compensation Plan, 
1155  pursuant to s. 766.305(2). The physician may submit a written 
1156  response to the information contained in the complaint or 
1157  document which resulted in the initiation of the investigation 
1158  within 45 days after service to the physician of the complaint 
1159  or document. The physician’s written response shall be 
1160  considered by the probable cause panel. 
1161         Section 16. Effective January 1, 2011, subsection (9) of 
1162  section 459.015, Florida Statutes, is amended to read: 
1163         459.015 Grounds for disciplinary action; action by the 
1164  board and department.— 
1165         (9) If When an investigation of an osteopathic physician is 
1166  undertaken, the department shall promptly furnish to the 
1167  osteopathic physician or his or her attorney a copy of the 
1168  complaint or document that which resulted in the initiation of 
1169  the investigation. For purposes of this subsection, such 
1170  documents include, but are not limited to: the pertinent 
1171  portions of an annual report submitted to the department 
1172  pursuant to s. 395.0197(6); a report of an adverse incident 
1173  which is provided to the department pursuant to s. 395.0197; a 
1174  report of peer review disciplinary action submitted to the 
1175  department pursuant to s. 395.0193(4) or s. 459.016, if provided 
1176  that the investigations, proceedings, and records relating to 
1177  such peer review disciplinary action shall continue to retain 
1178  their privileged status even as to the licensee who is the 
1179  subject of the investigation, as provided by ss. 395.0193(8) and 
1180  459.016(3); a report of a closed claim submitted pursuant to s. 
1181  627.912; a presuit notice submitted pursuant to s. 766.106(2); 
1182  and a petition brought under the Florida Birth-Related 
1183  Neurological Injury Compensation Plan, pursuant to s. 
1184  766.305(2). The osteopathic physician may submit a written 
1185  response to the information contained in the complaint or 
1186  document which resulted in the initiation of the investigation 
1187  within 45 days after service to the osteopathic physician of the 
1188  complaint or document. The osteopathic physician’s written 
1189  response shall be considered by the probable cause panel. 
1190         Section 17. Effective January 1, 2011, section 641.55, 
1191  Florida Statutes, is amended to read: 
1192         641.55 Internal risk management program.— 
1193         (1) Every organization certified under this part shall, As 
1194  a part of its administrative functions, each certified 
1195  organization shall establish an internal risk management program 
1196  that includes all of which shall include the following 
1197  components: 
1198         (a) The investigation and analysis of the frequency and 
1199  causes of general categories and specific types of adverse 
1200  incidents causing injury to patients; 
1201         (b) The development of appropriate measures to minimize the 
1202  risk of injuries and adverse incidents causing injury to 
1203  patients, including risk management and risk prevention 
1204  education and training of all nonphysician personnel as follows: 
1205         1. Such education and training of all nonphysician 
1206  personnel as part of their initial orientation; and 
1207         2. At least 1 hour of such education and training annually 
1208  for all nonphysician personnel of the organization who work in 
1209  clinical areas and provide patient care; 
1210         (c) The analysis of patient grievances which relate to 
1211  patient care and the quality of medical services; and 
1212         (d) The development and implementation of a an incident 
1213  reporting system for adverse incidents based upon the 
1214  affirmative duty of all providers and all agents and employees 
1215  of the organization to report such injuries and adverse 
1216  incidents to the risk manager. 
1217         (2) The risk management program is shall be the 
1218  responsibility of the governing authority or board of the 
1219  organization. Every organization that which has an annual 
1220  premium volume of $10 million or more and that which directly 
1221  provides health care in a building owned or leased by the 
1222  organization shall hire a risk manager, certified under ss. 
1223  395.10971-395.10975, who is shall be responsible for 
1224  implementation of the organization’s risk management program 
1225  required by this section. A part-time risk manager may shall not 
1226  be responsible for risk management programs in more than four 
1227  organizations or facilities. Every organization that which does 
1228  not directly provide health care in a building owned or leased 
1229  by the organization and every organization with an annual 
1230  premium volume of less than $10 million shall designate an 
1231  officer or employee of the organization to serve as the risk 
1232  manager. 
1233         (3) In addition to the programs mandated by this section, 
1234  other innovative approaches intended to reduce the frequency and 
1235  severity of medical malpractice and patient injury claims shall 
1236  be encouraged and their implementation and operation 
1237  facilitated. Additional approaches may include extending risk 
1238  management programs to provider offices or facilities. 
1239         (3)(4) The agency for Health Care Administration shall 
1240  adopt rules necessary to carry out the provisions of this 
1241  section, including rules governing the establishment of required 
1242  internal risk management programs to meet the needs of 
1243  individual organizations and each specific organization type 
1244  governed by this part. The office shall assist the agency in 
1245  preparing these rules. Each internal risk management program 
1246  must shall include the use of adverse incident reports to be 
1247  filed with the risk manager. The risk manager shall have free 
1248  access to all organization or provider medical records. The 
1249  incident reports are shall be considered to be a part of the 
1250  workpapers of the attorney defending the organization in 
1251  litigation relating to the organization thereto and are shall be 
1252  subject to discovery, but not be admissible as evidence in 
1253  court. A, nor shall any person filing such an incident report is 
1254  not be subject to civil suit by virtue of the incident report 
1255  and the matters it contains. As a part of each internal risk 
1256  management program, the incident reports shall be used utilized 
1257  to develop categories of adverse incidents which identify 
1258  problem areas. Once identified, procedures must be adjusted to 
1259  correct these problem areas. 
1260         (4) For an incident to be an adverse incident that must be 
1261  reported to the agency pursuant to this section, it must be: of 
1262  concern to both the public and health care practitioners and 
1263  providers; clearly identifiable and measurable and thus feasible 
1264  to include in a reporting system; and of such a nature that the 
1265  risk of occurrence is significantly influenced by the policies 
1266  and procedures of the organization. In addition, the incident 
1267  must be unambiguous, usually preventable, serious, and any of 
1268  the following: adverse; indicative of a problem in the 
1269  facility’s safety systems; or important for public credibility 
1270  or public accountability. The incident must also be on the most 
1271  current list set forth by the National Quality Forum. 
1272         (5)� Adverse incident must be reported electronically by the 
1273  organization through an online portal to the agency within 15 
1274  calendar days after the occurrence. The agency may grant an 
1275  extension to this reporting requirement upon receiving 
1276  justification submitted by the organization’s administrator to 
1277  the agency. 
1278         (a) All adverse incidents listing an individual licensed by 
1279  the Department of Health as directly involved in the incident 
1280  must be immediately forwarded to the Department of Health and 
1281  are subject to s. 456.073. 
1282         (b) The reports are exempt from disclosure under chapter 
1283  119 or any other law providing access to public records; not 
1284  discoverable or admissible in any civil or administrative 
1285  action, except in disciplinary proceedings by the Department of 
1286  Health or the appropriate regulatory authority; and are not 
1287  available to the public as part of the record of investigation 
1288  for and prosecution in disciplinary proceedings ordinarily made 
1289  available to the public. 
1290         (c) The organization’s chief executive officer, or 
1291  designee, shall certify quarterly, through the electronic 
1292  submission portal, that all adverse incidents from the previous 
1293  quarter have been reported and that the reports are accurate. 
1294         (6) Within 60 days after the occurrence of an adverse 
1295  incident, the agency shall require the organization to 
1296  electronically submit a final report. The final report should 
1297  include a copy of the root-cause analysis, any risk management 
1298  or patient safety lessons learned, the plan of correction, and 
1299  the results obtained during the plan’s implementation in the 
1300  organization. The agency may investigate adverse incidents and 
1301  prescribe measures that must or may be taken in response to the 
1302  incident. These reports are exempt from disclosure under chapter 
1303  119 or any other law providing access to public records, and are 
1304  not discoverable or admissible in any civil or administrative 
1305  action. 
1306         (7) The agency shall have access to all of the 
1307  organization’s records necessary to carry out the provisions of 
1308  this section. The records obtained by the agency under 
1309  subsection (6) or subsection (7) are exempt from disclosure 
1310  under s. 119.07(1) and are not discoverable or admissible in any 
1311  civil or administrative action, except in disciplinary 
1312  proceedings by the agency, the Department of Health, or the 
1313  appropriate regulatory board. Records obtained pursuant to s. 
1314  456.071 may not be made available to the public as part of the 
1315  record of investigation for and prosecution in disciplinary 
1316  proceedings. 
1317         (5)(a) Each organization subject to this section must 
1318  submit an annual report to the agency summarizing the incident 
1319  reports that were filed in the organization during the preceding 
1320  calendar year pertaining to services rendered on the premises of 
1321  the organization. The report must be on a form prescribed by 
1322  rule of the agency and must include, with respect to medical 
1323  services rendered on the premises of the organization: 
1324         1. The total number of adverse incidents causing injury to 
1325  patients. 
1326         2. A listing, by category, of the types of operations, 
1327  diagnostic or treatment procedures, or other actions causing the 
1328  injuries and the number of incidents occurring within each 
1329  category. 
1330         3. A listing, by category, of the types of injuries caused 
1331  and the number of incidents occurring within each category. 
1332         4. The name of each provider or a code number using each 
1333  health care professional’s license number and a separate code 
1334  number identifying all other individuals directly involved in 
1335  adverse incidents causing injury to a patient, the relationship 
1336  of the individual or provider to the organization, and the 
1337  number of incidents with the organization in which each 
1338  individual or provider has been directly involved. Each 
1339  organization must maintain names of the health care 
1340  professionals and individuals identified by code numbers for 
1341  purposes of this section. 
1342         5. A description of all medical malpractice claims filed 
1343  against the organization or its providers, including the total 
1344  number of pending and closed claims and the nature of the 
1345  incident that led to, the persons involved in, and the status 
1346  and disposition of each claim. Each report must update status 
1347  and disposition for all prior reports. 
1348         6. A report of all disciplinary actions taken against any 
1349  provider or any medical staff member of the organization, 
1350  including the nature and cause of the action. 
1351         (b) The information reported to the agency under paragraph 
1352  (a) which relates to providers licensed under chapter 458, 
1353  chapter 459, chapter 461, or chapter 466 must also be reported 
1354  to the agency quarterly. The agency shall review the information 
1355  and determine whether any of the incidents potentially involved 
1356  conduct by a licensee that is subject to disciplinary action, in 
1357  which case s. 456.073 applies. 
1358         (c) Except as otherwise provided in this subsection, any 
1359  identifying information contained in the annual report and the 
1360  quarterly reports under paragraphs (a) and (b) is confidential 
1361  and exempt from s. 119.07(1). This information must not be 
1362  available to the public as part of the record of investigation 
1363  for and prosecution in disciplinary proceedings made available 
1364  to the public by the agency or the appropriate regulatory board. 
1365  However, the agency shall make available, upon written request 
1366  by a practitioner against whom probable cause has been found, 
1367  any such information contained in the records that form the 
1368  basis of the determination of probable cause under s. 456.073. 
1369         (d) The annual report shall also contain the name of the 
1370  risk manager of the organization, a copy of its policy and 
1371  procedures governing the measures taken by the organization and 
1372  its risk manager to reduce the risk of injuries and adverse or 
1373  untoward incidents, and the result of these measures. 
1374         (6) If an adverse or untoward incident, whether occurring 
1375  in the facilities of the organization or arising from health 
1376  care prior to enrollment by the organization or admission to the 
1377  facilities of the organization or in a facility of one of its 
1378  providers, results in: 
1379         (a) The death of a patient; 
1380         (b) Severe brain or spinal damage to a patient; 
1381         (c) A surgical procedure being performed on the wrong 
1382  patient; or 
1383         (d) A surgical procedure unrelated to the patient’s 
1384  diagnosis or medical needs being performed on any patient, 
1385 
1386  the organization must report this incident to the agency within 
1387  3 working days after its occurrence. A more detailed followup 
1388  report must be submitted to the agency within 10 days after the 
1389  first report. The agency may require an additional, final 
1390  report. Reports under this subsection must be sent immediately 
1391  by the agency to the appropriate regulatory board whenever they 
1392  contain references to a provider licensed under chapter 458, 
1393  chapter 459, chapter 461, or chapter 466. These reports are 
1394  confidential and are exempt from s. 119.07(1). This information 
1395  is not available to the public as part of the record of 
1396  investigation for and prosecution in disciplinary proceedings 
1397  made available to the public by the agency or the appropriate 
1398  regulatory board. However, the agency shall make available, upon 
1399  written request by a practitioner against whom probable cause 
1400  has been found, any such information contained in the records 
1401  that form the basis of the determination of probable cause under 
1402  s. 456.073. The agency may investigate, as it deems appropriate, 
1403  any such incident and prescribe measures that must or may be 
1404  taken by the organization in response to the incident. The 
1405  agency shall review each incident and determine whether it 
1406  potentially involved conduct by the licensee which is subject to 
1407  disciplinary action, in which case s. 456.073 applies. 
1408         (8)(7) In addition to any penalty imposed under s. 641.52, 
1409  the agency may impose an administrative fine, not to exceed 
1410  $5,000, for any violation of the reporting requirements of 
1411  subsection (5) or subsection (6). 
1412         (9)(8) The Department of Health agency and, upon issuance 
1413  of a subpoena issued under s. 456.071, and the appropriate 
1414  regulatory board must be given access to all organization 
1415  records necessary to carry out the provisions of this section. 
1416  Any identifying information contained in the records obtained 
1417  under this section is confidential and exempt from s. 119.07(1). 
1418  The identifying information contained in records obtained under 
1419  s. 456.071 is exempt from s. 119.07(1) if to the extent that it 
1420  is part of the record of investigation for and prosecution in 
1421  disciplinary proceedings made available to the public by the 
1422  agency, the department, or the appropriate regulatory board. 
1423  However, the agency must make available, upon written request by 
1424  a practitioner against whom probable cause has been found, any 
1425  such information contained in the records that form the basis of 
1426  the determination of probable cause under s. 456.073, except 
1427  that, with respect to medical review committee records, s. 
1428  766.101 controls. 
1429         (10)(9) At least annually, the agency shall review, no less 
1430  frequently than annually, the risk management program of each 
1431  organization regulated by this section to determine whether the 
1432  program meets the standards established in statutes and rules, 
1433  whether the program is being conducted in a manner designed to 
1434  reduce adverse incidents, and whether the program is 
1435  appropriately reporting such incidents under subsections (5) and 
1436  (6). 
1437         (11)(10) There shall be No monetary liability on the part 
1438  of, and no cause of action for damages shall arise against, any 
1439  risk manager certified under part IX of chapter 626 for the 
1440  implementation and oversight of the risk management program in 
1441  an organization authorized under this chapter for any act or 
1442  proceeding undertaken or performed within the scope of the 
1443  function of such risk management program if the risk manager 
1444  acts without intentional fraud. 
1445         (11) If the agency, through its receipt of the annual 
1446  reports prescribed in subsection (5) or through any 
1447  investigation, has a reasonable belief that conduct by a 
1448  provider, staff member, or employee of an organization may 
1449  constitute grounds for disciplinary action by the appropriate 
1450  regulatory board, the agency shall report this fact to the 
1451  regulatory board. 
1452         (12) The agency shall send information bulletins to all 
1453  organizations as necessary to disseminate trends and preventive 
1454  data derived from its actions under this section or under s. 
1455  395.0197. 
1456         (12) The gross data compiled under this section or s. 
1457  395.0197 shall be furnished by the agency upon request to 
1458  organizations to be used utilized for risk management purposes. 
1459         (13) The agency shall adopt rules necessary to administer 
1460  carry out the provisions of this section. 
1461         Section 18. Adult living facilities have become the 
1462  preferred environment for individuals needing assistance with 
1463  personal care services as they age and strive to function while 
1464  having varying degrees of physical or mental impairments. It is 
1465  the intent of the Legislature that rules adopted and enforced in 
1466  assisted living facilities include firesafety standards that 
1467  ensure a safe and secure quality of life for residents. 
1468         (1) Under chapter 633, Florida Statutes, the State Fire 
1469  Marshal is directed to adopt the Florida Fire Prevention Code 
1470  for statewide application using the most current edition of the 
1471  Life Safety Code. Assisted living facilities are governed by 
1472  chapter 429, Florida Statutes, which permits compliance with 
1473  1988 firesafety standards and other standards governing 
1474  firesafety, including the 1994 edition of the Life Safety Code. 
1475         (2) The State Fire Marshal is directed to conduct a study 
1476  of the effectiveness of currently adopted firesafety standards 
1477  for assisted living facilities and evaluate whether the 
1478  continued use of such standards sufficiently ensures the safety 
1479  of staff and residents in the case of a fire emergency. The 
1480  study shall include input from the Department of Elderly 
1481  Affairs, the Agency for Health Care Administration, the 
1482  Department of Health, and trade organizations representing 
1483  assisted living facilities. The study shall address, but need 
1484  not be limited to, the establishment of uniform firesafety 
1485  standards for fire alarms and other fire protections based on 
1486  the size of the structure. 
1487         (3) The State Fire Marshal shall complete the study and 
1488  provide a report to the Governor, the President of the Senate, 
1489  and the Speaker of the House of Representatives by November 15, 
1490  2010. The report shall include, but need not be limited to, 
1491  recommendations for legislative changes that will enhance the 
1492  current firesafety standards of assisted living facilities 
1493  without causing significant adverse impact on the residents or 
1494  the individual caregivers. 
1495         Section 19. Except as otherwise expressly provided in this 
1496  act, this act shall take effect upon becoming a law.