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.