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       Florida Senate - 2010                                     SB 912
       By Senator Peaden
       2-00358A-10                                            2010912__
    1                        A bill to be entitled                      
    2         An act relating to clinical perfusionists; amending s.
    3         456.048, F.S.; specifying financial responsibility
    4         requirements for clinical perfusionists; creating s.
    5         468.901, F.S.; providing definitions; requiring a
    6         supervising physician to be qualified in the medical
    7         area in which the clinical perfusionist performs;
    8         prescribing duties of a clinical perfusionist;
    9         requiring a clinical perfusionist to convey to a
   10         patient that he or she is a clinical perfusionist;
   11         authorizing a clinical perfusionist to perform medical
   12         tasks and services within a certain protocol;
   13         prohibiting a clinical perfusionist from prescribing,
   14         ordering, compounding, or dispensing certain drugs or
   15         medical devices; providing that a clinical
   16         perfusionist may administer certain drugs, fluids, and
   17         blood products under the supervision of a physician;
   18         exempting a perfusionist in training from requirements
   19         of a clinical perfusionist; requiring board approval
   20         of training programs for clinical perfusionists;
   21         providing certification requirements; providing
   22         provisional certifying requirements; providing for a
   23         temporary certificate as a clinical perfusionist;
   24         authorizing the Board of Medicine and the Board of
   25         Osteopathic Medicine to impose a penalty against a
   26         clinical perfusionist found guilty of or investigated
   27         for violating ch. 456, ch. 457, or ch. 458, F.S.;
   28         authorizing the chairpersons of the Board of Medicine
   29         and the Board of Osteopathic Medicine to appoint
   30         certain persons to advise the boards regarding rules
   31         for the certification of clinical perfusionists;
   32         providing duties of the boards; providing for the
   33         denial, suspension, or revocation of a certificate;
   34         requiring the boards to adopt rules; requiring the
   35         Department of Health to allocate fees collected to the
   36         boards; providing exemptions from certification
   37         requirements for clinical perfusionists; exempting
   38         hospitals from payment of certain costs; providing
   39         that the act does not prevent reimbursement of
   40         employers of clinical perfusionists; providing an
   41         effective date.
   43  Be It Enacted by the Legislature of the State of Florida:
   45         Section 1. Section 456.048, Florida Statutes, is amended to
   46  read:
   47         456.048 Financial responsibility requirements for certain
   48  health care practitioners.—
   49         (1) As a prerequisite for licensure or license renewal, the
   50  Board of Acupuncture, the Board of Chiropractic Medicine, the
   51  Board of Podiatric Medicine, and the Board of Dentistry shall,
   52  by rule, require that all health care practitioners licensed
   53  under the respective board, and the Board of Medicine and the
   54  Board of Osteopathic Medicine shall, by rule, require that all
   55  anesthesiologist assistants licensed pursuant to s. 458.3475 or
   56  s. 459.023, and clinical perfusionists certified pursuant to s.
   57  468.901, and the Board of Nursing shall, by rule, require that
   58  advanced registered nurse practitioners certified under s.
   59  464.012, and the department shall, by rule, require that
   60  midwives maintain medical malpractice insurance or provide proof
   61  of financial responsibility in an amount and in a manner
   62  determined by the board or department to be sufficient to cover
   63  claims arising out of the rendering of or failure to render
   64  professional care and services in this state.
   65         (2) The board or department may grant exemptions upon
   66  application by practitioners meeting any of the following
   67  criteria:
   68         (a) Any person licensed under chapter 457, s. 458.3475, s.
   69  459.023, chapter 460, chapter 461, s. 464.012, chapter 466, or
   70  chapter 467, or certified under s. 468.901, who practices
   71  exclusively as an officer, employee, or agent of the Federal
   72  Government or of the state or its agencies or its subdivisions.
   73  For the purposes of this subsection, an agent of the state, its
   74  agencies, or its subdivisions is a person who is eligible for
   75  coverage under any self-insurance or insurance program
   76  authorized by the provisions of s. 768.28(16) or who is a
   77  volunteer under s. 110.501(1).
   78         (b) Any person whose license or certification has become
   79  inactive under chapter 457, s. 458.3475, s. 459.023, chapter
   80  460, chapter 461, part I of chapter 464, chapter 466, or chapter
   81  467, or s. 468.901 and who is not practicing in this state. Any
   82  person applying for reactivation of a license must show either
   83  that such licensee maintained tail insurance coverage which
   84  provided liability coverage for incidents that occurred on or
   85  after October 1, 1993, or the initial date of licensure in this
   86  state, whichever is later, and incidents that occurred before
   87  the date on which the license became inactive; or such licensee
   88  must submit an affidavit stating that such licensee has no
   89  unsatisfied medical malpractice judgments or settlements at the
   90  time of application for reactivation.
   91         (c) Any person holding a limited license pursuant to s.
   92  456.015, and practicing under the scope of such limited license.
   93         (d) Any person licensed or certified under chapter 457, s.
   94  458.3475, s. 459.023, chapter 460, chapter 461, s. 464.012,
   95  chapter 466, or chapter 467, or s. 468.901 who practices only in
   96  conjunction with his or her teaching duties at an accredited
   97  school or in its main teaching hospitals. Such person may engage
   98  in the practice of medicine to the extent that such practice is
   99  incidental to and a necessary part of duties in connection with
  100  the teaching position in the school.
  101         (e) Any person holding an active license or certification
  102  under chapter 457, s. 458.3475, s. 459.023, chapter 460, chapter
  103  461, s. 464.012, chapter 466, or chapter 467, or s. 468.901 who
  104  is not practicing in this state. If such person initiates or
  105  resumes practice in this state, he or she must notify the
  106  department of such activity.
  107         (f) Any person who can demonstrate to the board or
  108  department that he or she has no malpractice exposure in the
  109  state.
  110         (3) Notwithstanding the provisions of this section, the
  111  financial responsibility requirements of ss. 458.320 and
  112  459.0085 shall continue to apply to practitioners licensed under
  113  those chapters, except for anesthesiologist assistants licensed
  114  pursuant to s. 458.3475 or s. 459.023 who must meet the
  115  requirements of this section.
  116         Section 2. Section 468.901, Florida Statutes, is created to
  117  read:
  118         468.901Clinical perfusionists.—
  119         (1)DEFINITIONS.—As used in this section, the term:
  120         (a)“Approved program” means a program for the education
  121  and training of clinical perfusion which is approved by the
  122  boards as provided in subsection (5).
  123         (b)“Boards” means the Board of Medicine and the Board of
  124  Osteopathic Medicine.
  125         (c)“Clinical perfusionist” means a person who has
  126  graduated from an approved program, who is certified pursuant to
  127  this section to perform medical services, and who is prescribed,
  128  delegated, or supervised by a licensed physician.
  129         (d)“Clinical perfusion” means the functions necessary for
  130  the support, treatment, measurement, or supplementation of the
  131  cardiovascular, circulatory, or respiratory systems or other
  132  organs, or a combination of those activities, and the safe
  133  management of physiologic functions by monitoring and analyzing
  134  the parameters of the systems, under an order and the
  135  supervision of a physician licensed under chapter 458 or chapter
  136  459, through extracorporeal circulation, long-term clinical
  137  support techniques, including extracorporeal carbon-dioxide
  138  removal and extracorporeal membrane oxygenation, and associated
  139  therapeutic and diagnostic technologies, such as counter
  140  pulsation, ventricular assistance, auto transfusion, blood
  141  conservation techniques, myocardial and organ preservation,
  142  extracorporeal life support, isolated limb perfusion,
  143  therapeutic aphaeresis, and platelet rich plasma sequestration.
  144         (e)“Clinical perfusionist’s protocol” means perfusion
  145  related policies and protocols developed or approved by a
  146  licensed health facility or a physician through collaboration
  147  with administrators, certified clinical perfusionists, and other
  148  health care professionals.
  149         (f)“Continuing medical education” means courses recognized
  150  and approved by the boards, the American Academy of Physician
  151  Assistants, the American Medical Association, the American
  152  Osteopathic Association, the American Board of Cardiovascular
  153  Perfusion, or the Accreditation Council on Continuing Medical
  154  Education.
  155         (g)“Department” means the Department of Health.
  156         (h)“Direct supervision” means the onsite, personal
  157  supervision by a clinical perfusionist who is present when a
  158  procedure is being performed and who is in all instances
  159  immediately available to provide assistance and direction while
  160  clinical perfusion services are being performed.
  161         (i)“Extracorporeal circulation” means the diversion of a
  162  patient’s blood through a heart-lung machine or a similar device
  163  that assumes the functions of the patient’s heart, lungs,
  164  kidney, liver, or other organs.
  165         (j)“Perfusionist in training” means a student enrolled in
  166  an approved program who has not yet passed the proficiency
  167  examination and works under the direct supervision of a clinical
  168  perfusionist.
  169         (k)“Proficiency examination” means an entry-level
  170  examination administered by the American Board of Cardiovascular
  171  Perfusion.
  172         (l)“Provisional certified clinical perfusionist” means a
  173  person provisionally certified under this section.
  174         (m)“Supervising physician” means a physician licensed
  175  under chapter 458 or chapter 459 who holds an active license.
  176         (n) “Temporary clinical perfusionist” means a person
  177  granted a temporary certificate under this section.
  178         (2)PERFORMANCE OF A SUPERVISING PHYSICIAN.—A physician who
  179  supervises a clinical perfusionist must be qualified in the
  180  medical areas in which the clinical perfusionist performs.
  182  perfusionist may perform duties established by rule by the
  183  boards, including the following duties that are included in the
  184  clinical perfusionist’s protocol, if prescribed by a physician
  185  or under the supervision of a physician:
  186         1.Perform extracorporeal circulation and its clinical
  187  support;
  188         2.Perform or administer counter pulsation;
  189         3.Perform circulatory support and ventricular assistance;
  190         4.Perform extracorporeal membrane oxygenation and
  191  extracorporeal life support;
  192         5.Perform blood conservation techniques, autotransfusion,
  193  and blood component sequestration;
  194         6.Perform myocardial preservation;
  195         7.Perform coagulation and hematologic monitoring;
  196         8.Perform physiological monitoring;
  197         9.Perform blood gas and blood chemistry monitoring;
  198         10.Perform induction of hypothermia or hyperthermia with
  199  reversal;
  200         11.Perform hemodilution;
  201         12.Perform hemofiltration;
  202         13.Administer blood, blood products, supportive fluids,
  203  and anesthetic agents via the extracorporeal circuit;
  204         14.Perform isolated limb and organ perfusion;
  205         15.Provide surgical assistance;
  206         16.Perform organ preservation;
  207         17.Perform dialysis while on clinical bypass;
  208         18.Perform therapeutic apheresis;
  209         19.Administer blood, blood products, and supportive fluids
  210  via the therapeutic apheresis circuit; and
  211         20.Perform pacemaker lead and battery analysis.
  212         (b)A clinical perfusionist shall clearly convey to a
  213  patient that he or she is a clinical perfusionist.
  214         (c)A clinical perfusionist may perform medical tasks and
  215  services within the framework of a written practice protocol
  216  developed between the supervising physician and the clinical
  217  perfusionist.
  218         (d)A clinical perfusionist may not prescribe, order,
  219  compound, or dispense any controlled substance, legend drug, or
  220  medical device to any patient. This paragraph does not prohibit
  221  a clinical perfusionist from administering legend drugs,
  222  controlled substances, intravenous drugs, fluids, or blood
  223  products that are ordered by the physician and administered to a
  224  patient while under the orders of such physician.
  226  of a perfusionist in training is exempt from the requirements of
  227  this section while the perfusionist in training is performing
  228  assigned tasks in conjunction with an approved program. Before
  229  providing clinical perfusion in conjunction with the
  230  requirements of an approved program, the perfusionist in
  231  training shall clearly convey to the patient that he or she is a
  232  perfusionist in training and is under direct supervision.
  233         (5)PROGRAM APPROVAL.—The boards shall approve programs for
  234  the education and training of clinical perfusionists which hold
  235  full accreditation or provisional accreditation from the
  236  Commission on Accreditation of Allied Health Education Programs
  237  or a successor organization, as approved by the boards.
  239         (a)Any person seeking to be certified as a clinical
  240  perfusionist must apply to the department. The department shall
  241  issue a certificate to any person certified by the boards to:
  242         1.Be at least 21 years of age.
  243         2.Have satisfactorily passed a proficiency examination
  244  approved by the boards. The boards, on receipt of an application
  245  and application fee, shall waive the examination requirement for
  246  an applicant who at the time of application holds a current
  247  certificate issued by a certifying agency approved by the
  248  boards.
  249         3.Be certified in basic cardiac life support.
  250         4.Have completed the application form and remitted an
  251  application fee, not to exceed $1,000, as set by the department.
  252  An application must include:
  253         a.A certificate of completion of an approved program or
  254  its equivalent;
  255         b.A sworn statement of any prior felony convictions;
  256         c.A sworn statement of any prior discipline or denial of
  257  certification or license in any state;
  258         d.Two letters of recommendation, one from a physician and
  259  one from a certified clinical perfusionist; and
  260         e.A set of fingerprints on a form and under procedures
  261  specified by the department, along with payment in an amount
  262  equal to the costs incurred by the department for a national
  263  criminal history check of the applicant.
  265  Before January 1, 2011, a person is eligible to apply to the
  266  boards and receive a certification notwithstanding the
  267  requirements of this subsection if the person was actively
  268  engaged in the practice of perfusion consistent with applicable
  269  law, and if the person was operating cardiopulmonary bypass
  270  systems during cardiac surgical cases in a licensed health care
  271  facility in this state as the person’s primary function and had
  272  been operating the system for at least 9 of the 10 years
  273  preceding application for certification.
  274         (b)Between July 1, 2010, and June 30, 2011, an applicant
  275  who was not a graduate of an accredited program before 1981, but
  276  met the then-current eligibility requirements for certification
  277  as a certified clinical perfusionist and subsequently was
  278  certified, shall be certified as a perfusionist if the
  279  application otherwise complies with this section.
  280         (c)A certificate must be renewed biennially. Each renewal
  281  must include:
  282         1.A renewal fee, not to exceed $1,000, as set by the
  283  department; and
  284         2.A sworn statement of no felony convictions in the
  285  immediately preceding 2 years.
  286         (d)Each certified clinical perfusionist shall biennially
  287  complete continuing medical education as required by the boards.
  288         (e)1.A certificate as a provisional certified clinical
  289  perfusionist may be issued by the boards to a person who has
  290  successfully completed an approved perfusion education program,
  291  completed an application and remitted an application fee, and
  292  submitted evidence satisfactory to the boards of the successful
  293  completion of the requisite education requirements.
  294         2.A provisional certified clinical perfusionist must be
  295  under the supervision and direction of a certified clinical
  296  perfusionist at all times during which the provisional certified
  297  clinical perfusionist performs the prescribed duties.
  298         3.A provisional certificate is valid for 2 years following
  299  the date it is issued and may be extended subject to rule by the
  300  boards. The application for extension must be signed by a
  301  supervising certified clinical perfusionist. Upon notification
  302  by the approved testing service, or the boards, that any portion
  303  of the certifying examination has been failed after the 2-year
  304  provisional certificate term, the provisional certificate must
  305  be surrendered to the boards.
  306         (f)A certificate as a temporary clinical perfusionist may
  307  be issued by the department to a person who has successfully
  308  completed the application for perfusion certification and met
  309  other requirements as established by the boards.
  310         (g)The boards shall adopt rules governing supervisory
  311  requirements between clinical perfusionists and provisional
  312  certified clinical perfusionists, temporary clinical
  313  perfusionists, and clinical perfusionists in training.
  314         (h)The Board of Medicine may impose upon a clinical
  315  perfusionist any penalty specified in s. 456.072 or s.
  316  458.331(2) if the clinical perfusionist is found guilty of or is
  317  investigated for an act that constitutes a violation of chapter
  318  456, chapter 457, or chapter 458.
  321         (a)The chairpersons of the Board of Medicine and the Board
  322  of Osteopathic Medicine may appoint a cardiovascular surgeon and
  323  a certified clinical perfusionist to advise the boards as to the
  324  adoption of rules for the certification of clinical
  325  perfusionists. The boards may use a committee structure that is
  326  most practicable in order to receive any recommendations to the
  327  boards regarding rules and all matters relating to clinical
  328  perfusionists, including, but not limited to, recommendations to
  329  improve safety in the clinical practices of certified clinical
  330  perfusionists.
  331         (b)In addition to its other duties and responsibilities as
  332  prescribed by law, the boards shall:
  333         1.Recommend to the department the certification of
  334  clinical perfusionists.
  335         2.Develop rules regulating the use of clinical
  336  perfusionists under chapter 458 or chapter 459, except for rules
  337  relating to the formulary developed under s. 458.347(4). The
  338  boards shall also develop rules to ensure that the continuity of
  339  supervision is maintained in each practice setting. The boards
  340  shall consider adopting a proposed rule at the regularly
  341  scheduled meeting immediately following the submission of the
  342  proposed rule. A proposed rule may not be adopted by either
  343  board unless both boards have accepted and approved the
  344  identical language contained in the proposed rule. The
  345  provisions of all the proposed rules must be approved by both
  346  boards pursuant to each respective board’s guidelines and
  347  standards regarding the adoption of proposed rules.
  348         3.Address concerns and problems of clinical perfusionists
  349  to improve safety in the clinical practices of certified
  350  clinical perfusionists.
  351         (c)When the boards find that an applicant for
  352  certification has failed to meet, to the boards’ satisfaction,
  353  any of the requirements for certification set forth in this
  354  section, the boards may enter an order to:
  355         1.Refuse to certify the applicant;
  356         2.Approve the applicant for certification with
  357  restrictions on the scope of practice; or
  358         3.Approve the applicant for provisional or temporary
  359  certification. Such conditions may include placement of the
  360  applicant on probation for a period of time and subject to such
  361  conditions as the boards specify, including, but not limited to,
  362  requiring the applicant to undergo treatment, to attend
  363  continuing medical education courses, or to take corrective
  364  action.
  366  boards may deny, suspend, or revoke the certification of a
  367  clinical perfusionist whom the boards determine have violated
  368  any provision of this section, chapter 456, chapter 458, or
  369  chapter 459 or any rule adopted pursuant thereto.
  370         (9)RULES.—The boards shall adopt rules to administer this
  371  section.
  372         (10)FEES.—The department shall allocate the fees collected
  373  under this section to the boards for the sole purpose of
  374  administering the provisions of this section.
  375         (11)EXEMPTIONS.—
  376         (a)This section does not limit the practice of a physician
  377  licensed under chapter 458 or chapter 459 or a respiratory
  378  therapist licensed under chapter 468, so long as that person
  379  does not hold himself or herself out to the public as possessing
  380  a certificate or provisional certificate issued under this
  381  section or use a professional title protected by this section.
  382         (b)This section does not limit the practice of nursing or
  383  prevent qualified members of other regulated health professions
  384  from doing work of a nature consistent with the state laws and
  385  rules that govern their respective health professions, so long
  386  as those persons do not hold themselves out to the public as
  387  possessing a certificate or provisional certificate issued under
  388  this section or use a professional title protected by this
  389  section.
  390         (c)A person need not be certified under this section who:
  391         1.Is a qualified person in this state or another state or
  392  territory who is employed by the United States Government or an
  393  agency thereof while discharging his or her official duties.
  394         2.Is a student providing services regulated under this
  395  chapter who is:
  396         a.Pursuing a course of study that leads to a degree in a
  397  profession regulated by this chapter;
  398         b.Providing services in a training setting, as long as
  399  such services and associated activities constitute part of a
  400  supervised course of study; and
  401         c.Designated by the title “perfusionist in training.”
  402         (d)The boards shall establish by rule the qualifications
  403  necessary for a clinical perfusionist who is not a resident of
  404  this state and is licensed or certified by any other state or
  405  territory of the United States. Such clinical perfusionist may
  406  not offer services in this state for more than 30 days in any
  407  calendar year.
  408         (e)Except as stipulated by the boards, the exemptions in
  409  this subsection do not apply to any person certified under this
  410  section whose certificate has been revoked or suspended by
  411  either of the boards or whose license or certification in
  412  another jurisdiction has been revoked or suspended by the
  413  licensing or certifying authority in that jurisdiction.
  414         (f)This subsection does not exempt a person from meeting
  415  the minimum standards of performance in professional activities
  416  when measured against generally prevailing peer performance,
  417  including the undertaking of activities for which the person is
  418  not qualified by training or experience.
  420         (a)A hospital is not required to pay for, or reimburse any
  421  person for, the costs of compliance with any requirement of this
  422  section, including costs of continuing medical education.
  423         (b)This section does not prevent third-party payors from
  424  reimbursing employers of clinical perfusionists for covered
  425  services rendered by such clinical perfusionists.
  426         Section 3. This act shall take effect July 1, 2010.

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