Florida Senate - 2019                        COMMITTEE AMENDMENT
       Bill No. PCS (192902) for SB 7078
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/19/2019           .                                

       The Committee on Appropriations (Bean) recommended the
    1         Senate Amendment to Amendment (520116) (with title
    2  amendment)
    4         Delete lines 46 - 206
    5  and insert:
    6         Section 3. Subsection (3) of section 395.002, Florida
    7  Statutes, is amended to read:
    8         395.002 Definitions.—As used in this chapter:
    9         (3) “Ambulatory surgical center” means a facility the
   10  primary purpose of which is to provide elective surgical care,
   11  in which the patient is admitted to and discharged from such
   12  facility within 24 hours the same working day and is not
   13  permitted to stay overnight, and which is not part of a
   14  hospital. However, a facility existing for the primary purpose
   15  of performing terminations of pregnancy, an office maintained by
   16  a physician for the practice of medicine, or an office
   17  maintained for the practice of dentistry may not be construed to
   18  be an ambulatory surgical center, provided that any facility or
   19  office which is certified or seeks certification as a Medicare
   20  ambulatory surgical center shall be licensed as an ambulatory
   21  surgical center pursuant to s. 395.003.
   22         Section 4. Section 395.1055, Florida Statutes, is amended
   23  to read:
   24         395.1055 Rules and enforcement.—
   25         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
   26  and 120.54 to implement the provisions of this part, which shall
   27  include reasonable and fair minimum standards for ensuring that:
   28         (a) Sufficient numbers and qualified types of personnel and
   29  occupational disciplines are on duty and available at all times
   30  to provide necessary and adequate patient care and safety.
   31         (b) Infection control, housekeeping, sanitary conditions,
   32  and medical record procedures that will adequately protect
   33  patient care and safety are established and implemented.
   34         (c) A comprehensive emergency management plan is prepared
   35  and updated annually. Such standards must be included in the
   36  rules adopted by the agency after consulting with the Division
   37  of Emergency Management. At a minimum, the rules must provide
   38  for plan components that address emergency evacuation
   39  transportation; adequate sheltering arrangements; postdisaster
   40  activities, including emergency power, food, and water;
   41  postdisaster transportation; supplies; staffing; emergency
   42  equipment; individual identification of residents and transfer
   43  of records, and responding to family inquiries. The
   44  comprehensive emergency management plan is subject to review and
   45  approval by the local emergency management agency. During its
   46  review, the local emergency management agency shall ensure that
   47  the following agencies, at a minimum, are given the opportunity
   48  to review the plan: the Department of Elderly Affairs, the
   49  Department of Health, the Agency for Health Care Administration,
   50  and the Division of Emergency Management. Also, appropriate
   51  volunteer organizations must be given the opportunity to review
   52  the plan. The local emergency management agency shall complete
   53  its review within 60 days and either approve the plan or advise
   54  the facility of necessary revisions.
   55         (d) Licensed facilities are established, organized, and
   56  operated consistent with established standards and rules.
   57         (e) Licensed facility beds conform to minimum space,
   58  equipment, and furnishings standards as specified by the
   59  department.
   60         (f) All hospitals submit such data as necessary to conduct
   61  certificate-of-need reviews required under part I of chapter
   62  408. Such data shall include, but shall not be limited to,
   63  patient origin data, hospital utilization data, type of service
   64  reporting, and facility staffing data. The agency may not
   65  collect data that identifies or could disclose the identity of
   66  individual patients. The agency shall utilize existing uniform
   67  statewide data sources when available and shall minimize
   68  reporting costs to hospitals.
   69         (g) Each hospital has a quality improvement program
   70  designed according to standards established by their current
   71  accrediting organization. This program will enhance quality of
   72  care and emphasize quality patient outcomes, corrective action
   73  for problems, governing board review, and reporting to the
   74  agency of standardized data elements necessary to analyze
   75  quality of care outcomes. The agency shall use existing data,
   76  when available, and shall not duplicate the efforts of other
   77  state agencies in order to obtain such data.
   78         (h) Licensed facilities make available on their Internet
   79  websites, no later than October 1, 2004, and in a hard copy
   80  format upon request, a description of and a link to the patient
   81  charge and performance outcome data collected from licensed
   82  facilities pursuant to s. 408.061.
   83         (i) All hospitals providing organ transplantation, neonatal
   84  intensive care services, inpatient psychiatric services,
   85  inpatient substance abuse services, or comprehensive medical
   86  rehabilitation meet the minimum licensure requirements adopted
   87  by the agency. Such licensure requirements must include quality
   88  of care, nurse staffing, physician staffing, physical plant,
   89  equipment, emergency transportation, and data reporting
   90  standards.
   91         (2) Separate standards may be provided for general and
   92  specialty hospitals, ambulatory surgical centers, and statutory
   93  rural hospitals as defined in s. 395.602.
   94         (3)(a)The agency, in consultation with the Board of
   95  Medicine and the Board of Osteopathic Medicine, shall adopt
   96  rules that establish requirements to ensure the safe and
   97  effective delivery of surgical care to children kept past
   98  midnight in ambulatory surgical centers. The rules must be
   99  consistent with the American College of Surgeons’ 2015 standards
  100  document entitled “Optimal Resources for Children’s Surgical
  101  Care” and must establish minimum standards for pediatric patient
  102  care in ambulatory surgical centers.
  103         (b) Ambulatory surgical centers may provide operative
  104  procedures that require a length of stay past midnight on the
  105  day of surgery for children younger than 18 years of age only if
  106  the agency authorizes the performance of such procedures by
  107  rule.
  108         (4)(3) The agency shall adopt rules with respect to the
  109  care and treatment of patients residing in distinct part nursing
  110  units of hospitals which are certified for participation in
  111  Title XVIII (Medicare) and Title XIX (Medicaid) of the Social
  112  Security Act skilled nursing facility program. Such rules shall
  113  take into account the types of patients treated in hospital
  114  skilled nursing units, including typical patient acuity levels
  115  and the average length of stay in such units, and shall be
  116  limited to the appropriate portions of the Omnibus Budget
  117  Reconciliation Act of 1987 (Pub. L. No. 100-203) (December 22,
  118  1987), Title IV (Medicare, Medicaid, and Other Health-Related
  119  Programs), Subtitle C (Nursing Home Reform), as amended. The
  120  agency shall require level 2 background screening as specified
  121  in s. 408.809(1)(e) pursuant to s. 408.809 and chapter 435 for
  122  personnel of distinct part nursing units.
  123         (5)(4) The agency shall adopt rules with respect to the
  124  care and treatment of clients in intensive residential treatment
  125  programs for children and adolescents and with respect to the
  126  safe and healthful development, operation, and maintenance of
  127  such programs.
  128         (6)(5) The agency shall enforce the provisions of part I of
  129  chapter 394, and rules adopted thereunder, with respect to the
  130  rights, standards of care, and examination and placement
  131  procedures applicable to patients voluntarily or involuntarily
  132  admitted to hospitals providing psychiatric observation,
  133  evaluation, diagnosis, or treatment.
  134         (7)(6) No rule shall be adopted under this part by the
  135  agency which would have the effect of denying a license to a
  136  facility required to be licensed under this part, solely by
  137  reason of the school or system of practice employed or permitted
  138  to be employed by physicians therein, provided that such school
  139  or system of practice is recognized by the laws of this state.
  140  However, nothing in this subsection shall be construed to limit
  141  the powers of the agency to provide and require minimum
  142  standards for the maintenance and operation of, and for the
  143  treatment of patients in, those licensed facilities which
  144  receive federal aid, in order to meet minimum standards related
  145  to such matters in such licensed facilities which may now or
  146  hereafter be required by appropriate federal officers or
  147  agencies in pursuance of federal law or promulgated in pursuance
  148  of federal law.
  149         (8)(7) Any licensed facility which is in operation at the
  150  time of promulgation of any applicable rules under this part
  151  shall be given a reasonable time, under the particular
  152  circumstances, but not to exceed 1 year from the date of such
  153  promulgation, within which to comply with such rules.
  154         (9)(8) The agency may not adopt any rule governing the
  155  design, construction, erection, alteration, modification,
  156  repair, or demolition of any public or private hospital,
  157  intermediate residential treatment facility, or ambulatory
  158  surgical center. It is the intent of the Legislature to preempt
  159  that function to the Florida Building Commission and the State
  160  Fire Marshal through adoption and maintenance of the Florida
  161  Building Code and the Florida Fire Prevention Code. However, the
  162  agency shall provide technical assistance to the commission and
  163  the State Fire Marshal in updating the construction standards of
  164  the Florida Building Code and the Florida Fire Prevention Code
  165  which govern hospitals, intermediate residential treatment
  166  facilities, and ambulatory surgical centers.
  167         (10)(9) The agency shall establish a pediatric cardiac
  168  technical advisory panel, pursuant to s. 20.052, to develop
  169  procedures and standards for measuring outcomes of pediatric
  170  cardiac catheterization programs and pediatric cardiovascular
  171  surgery programs.
  172         (a) Members of the panel must have technical expertise in
  173  pediatric cardiac medicine, shall serve without compensation,
  174  and may not be reimbursed for per diem and travel expenses.
  175         (b) Voting members of the panel shall include: 3 at-large
  176  members, and 3 alternate at-large members with different program
  177  affiliations, including 1 cardiologist who is board certified in
  178  caring for adults with congenital heart disease and 2 board
  179  certified pediatric cardiologists, neither of whom may be
  180  employed by any of the hospitals specified in subparagraphs 1.
  181  10. or their affiliates, each of whom is appointed by the
  182  Secretary of Health Care Administration, and 10 members, and an
  183  alternate for each member, each of whom is a pediatric
  184  cardiologist or a pediatric cardiovascular surgeon, each
  185  appointed by the chief executive officer of the following
  186  hospitals:
  187         1. Johns Hopkins All Children’s Hospital in St. Petersburg.
  188         2. Arnold Palmer Hospital for Children in Orlando.
  189         3. Joe DiMaggio Children’s Hospital in Hollywood.
  190         4. Nicklaus Children’s Hospital in Miami.
  191         5. St. Joseph’s Children’s Hospital in Tampa.
  192         6. University of Florida Health Shands Hospital in
  193  Gainesville.
  194         7. University of Miami Holtz Children’s Hospital in Miami.
  195         8. Wolfson Children’s Hospital in Jacksonville.
  196         9. Florida Hospital for Children in Orlando.
  197         10. Nemours Children’s Hospital in Orlando.
  199  Appointments made under subparagraphs 1.-10. are contingent upon
  200  the hospital’s maintenance of pediatric certificates of need and
  201  the hospital’s compliance with this section and rules adopted
  202  thereunder, as determined by the Secretary of Health Care
  203  Administration. A member appointed under subparagraphs 1.-10.
  204  whose hospital fails to maintain such certificates or comply
  205  with standards may serve only as a nonvoting member until the
  206  hospital restores such certificates or complies with such
  207  standards. A voting member may serve a maximum of two 2-year
  208  terms and may be reappointed to the panel after being retired
  209  from the panel for a full 2-year term.
  210         (c) The Secretary of Health Care Administration may appoint
  211  nonvoting members to the panel. Nonvoting members may include:
  212         1. The Secretary of Health Care Administration.
  213         2. The Surgeon General.
  214         3. The Deputy Secretary of Children’s Medical Services.
  215         4. Any current or past Division Director of Children’s
  216  Medical Services.
  217         5. A parent of a child with congenital heart disease.
  218         6. An adult with congenital heart disease.
  219         7. A representative from each of the following
  220  organizations: the Florida Chapter of the American Academy of
  221  Pediatrics, the Florida Chapter of the American College of
  222  Cardiology, the Greater Southeast Affiliate of the American
  223  Heart Association, the Adult Congenital Heart Association, the
  224  March of Dimes, the Florida Association of Children’s Hospitals,
  225  and the Florida Society of Thoracic and Cardiovascular Surgeons.
  226         (d) The panel shall meet biannually, or more frequently
  227  upon the call of the Secretary of Health Care Administration.
  228  Such meetings may be conducted telephonically, or by other
  229  electronic means.
  230         (e) The duties of the panel include recommending to the
  231  agency standards for quality of care, personnel, physical plant,
  232  equipment, emergency transportation, and data reporting for
  233  hospitals that provide pediatric cardiac services.
  234         (f) Beginning on January 1, 2020, and annually thereafter,
  235  the panel shall submit a report to the Governor, the President
  236  of the Senate, the Speaker of the House of Representatives, the
  237  Secretary of Health Care Administration, and the State Surgeon
  238  General. The report must summarize the panel’s activities during
  239  the preceding fiscal year and include data and performance
  240  measures on surgical morbidity and mortality for all pediatric
  241  cardiac programs.
  242         (g) Panel members are agents of the state for purposes of
  243  s. 768.28 throughout the good faith performance of the duties
  244  assigned to them by the Secretary of Health Care Administration.
  245         (11) The Secretary of Health Care Administration shall
  246  consult the pediatric cardiac technical advisory panel for an
  247  advisory recommendation on all certificate of need applications
  248  to establish pediatric cardiac surgical centers.
  249         (12)(10) Based on the recommendations of the pediatric
  250  cardiac technical advisory panel in subsection (9), the agency
  251  shall adopt rules for pediatric cardiac programs which, at a
  252  minimum, include:
  253         (a) Standards for pediatric cardiac catheterization
  254  services and pediatric cardiovascular surgery including quality
  255  of care, personnel, physical plant, equipment, emergency
  256  transportation, data reporting, and appropriate operating hours
  257  and timeframes for mobilization for emergency procedures.
  258         (b) Outcome standards consistent with nationally
  259  established levels of performance in pediatric cardiac programs.
  260         (c) Specific steps to be taken by the agency and licensed
  261  facilities when the facilities do not meet the outcome standards
  262  within a specified time, including time required for detailed
  263  case reviews and the development and implementation of
  264  corrective action plans.
  265         (13)(11) A pediatric cardiac program shall:
  266         (a) Have a pediatric cardiology clinic affiliated with a
  267  hospital licensed under this chapter.
  268         (b) Have a pediatric cardiac catheterization laboratory and
  269  a pediatric cardiovascular surgical program located in the
  270  hospital.
  271         (c) Have a risk adjustment surgical procedure protocol
  272  following the guidelines established by the Society of Thoracic
  273  Surgeons.
  274         (d) Have quality assurance and quality improvement
  275  processes in place to enhance clinical operation and patient
  276  satisfaction with services.
  277         (e) Participate in the clinical outcome reporting systems
  278  operated by the Society of Thoracic Surgeons and the American
  279  College of Cardiology.
  280         (14)(a) The Secretary of Health Care Administration may
  281  request announced or unannounced site visits to any existing
  282  pediatric cardiac surgical center or facility seeking licensure
  283  as a pediatric cardiac surgical center through the certificate
  284  of need process, to ensure compliance with this section and
  285  rules adopted hereunder.
  286         (b) At the request of the Secretary of Health Care
  287  Administration, the pediatric cardiac technical advisory panel
  288  shall recommend in-state physician experts to conduct an on-site
  289  visit. The Secretary may also appoint up to two out-of-state
  290  physician experts.
  291         (c) A site visit team shall conduct an on-site inspection
  292  of the designated hospital’s pediatric medical and surgical
  293  programs, and each member shall submit a written report of his
  294  or her findings to the panel. The panel shall discuss the
  295  written reports and present an advisory opinion to the Secretary
  296  of Health Care Administration which includes recommendations and
  297  any suggested actions for correction.
  298         (d) Each on-site inspection must include all of the
  299  following:
  300         1. An inspection of the program’s physical facilities,
  301  clinics, and laboratories.
  302         2. Interviews with support staff and hospital
  303  administrators.
  304         3.A review of:
  305         a. Randomly selected medical records and reports,
  306  including, but not limited to, advanced cardiac imaging,
  307  computed tomography, magnetic resonance imaging, cardiac
  308  ultrasound, cardiac catheterization, and surgical operative
  309  notes.
  310         b.The program’s clinical outcome data submitted to the
  311  Society of Thoracic Surgeons and the American College of
  312  Cardiology pursuant to s. 408.05(3)(k).
  313         c.Mortality reports from cardiac-related deaths that
  314  occurred in the previous year.
  315         d. Program volume data from the preceding year for
  316  interventional and electrophysiology catheterizations and
  317  surgical procedures.
  318         (15) The Surgeon General shall provide quarterly reports to
  319  the Secretary of Health Care Administration consisting of data
  320  from the Children’s Medical Services critical congenital heart
  321  disease screening program for review by the advisory panel.
  322         (16)(12) The agency may adopt rules to administer the
  324  ================= T I T L E  A M E N D M E N T ================
  325  And the title is amended as follows:
  326         Delete line 382
  327  and insert:
  328         395.002, F.S.; revising the definition of the term
  329         “ambulatory surgical center”; amending s. 395.1055,
  330         F.S.; requiring the Agency for Health Care
  331         Administration, in consultation with the Board of
  332         Medicine and the Board of Osteopathic Medicine, to
  333         adopt rules that establish requirements related to the
  334         delivery of surgical care to children in ambulatory
  335         surgical centers, in accordance with specified
  336         standards; specifying that ambulatory surgical centers
  337         may provide certain procedures only if authorized by
  338         agency rule; authorizing the