Florida Senate - 2011                        COMMITTEE AMENDMENT
       Bill No. SB 1736
       
       
       
       
       
       
                                Barcode 621216                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/22/2011           .                                
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       The Committee on Health Regulation (Latvala) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 3085 and 3086
    4  insert:
    5         Section 78. Subsections (1) and (9) of section 483.051,
    6  Florida Statutes, are amended to read:
    7         483.051 Powers and duties of the agency.—The agency shall
    8  adopt rules to implement this part, which rules must include,
    9  but are not limited to, the following:
   10         (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
   11  biennial licensure of all nonwaived clinical laboratories
   12  meeting the requirements of this part and shall prescribe the
   13  qualifications necessary for such licensure, including, but not
   14  limited to, an application for or proof of a certificate under
   15  Clinical Laboratory Improvement Amendments of 1988. A nonwaived
   16  laboratory is a laboratory that has not been granted a
   17  certificate of waiver by the Centers for Medicare and Medicaid
   18  Services under the Clinical Laboratory Improvement Amendments of
   19  1988 and the federal rules adopted thereunder.
   20         (9) ALTERNATE-SITE TESTING.—The agency, in consultation
   21  with the Board of Clinical Laboratory Personnel, shall adopt, by
   22  rule, the criteria for alternate-site testing to be performed
   23  under the supervision of a clinical laboratory director. The
   24  elements to be addressed in the rule include, but are not
   25  limited to: a hospital internal needs assessment; a protocol of
   26  implementation including tests to be performed and who will
   27  perform the tests; criteria to be used in selecting the method
   28  of testing to be used for alternate-site testing; minimum
   29  training and education requirements for those who will perform
   30  alternate-site testing, such as documented training, licensure,
   31  certification, or other medical professional background not
   32  limited to laboratory professionals; documented inservice
   33  training as well as initial and ongoing competency validation;
   34  an appropriate internal and external quality control protocol;
   35  an internal mechanism for identifying and tracking alternate
   36  site testing by the central laboratory; and recordkeeping
   37  requirements. Alternate-site testing locations must register
   38  when the clinical laboratory applies to renew its license. For
   39  purposes of this subsection, the term “alternate-site testing”
   40  means any laboratory testing done under the administrative
   41  control of a hospital, but performed out of the physical or
   42  administrative confines of the central laboratory.
   43  
   44  ================= T I T L E  A M E N D M E N T ================
   45         And the title is amended as follows:
   46         Delete line 249
   47  and insert:
   48         testing of employees and job applicants; amending s.
   49         483.051, F.S.; requiring the Agency for Health Care
   50         Administration to provide for biennial licensure of
   51         all nonwaived laboratories that meet certain
   52         requirements; requiring the agency to prescribe
   53         qualifications for such licensure; defining nonwaived
   54         laboratories as laboratories that do not have a
   55         certificate of waiver from the Centers for Medicare
   56         and Medicaid Services; deleting requirements for the
   57         registration of an alternate site testing location
   58         when the clinical laboratory applies to renew its
   59         license; amending s.