Florida Senate - 2013                              CS for SB 124
       
       
       
       By the Committee on Health Policy; and Senators Ring and Clemens
       
       
       
       
       588-01568-13                                           2013124c1
    1                        A bill to be entitled                      
    2         An act relating to newborn screening for critical
    3         congenital heart disease; amending s. 383.14, F.S.;
    4         requiring the Department of Health to adopt and
    5         enforce rules that require ambulatory surgical
    6         centers, hospitals, and birth centers in this state to
    7         conduct screening for critical congenital heart
    8         defects in all newborns by using certain technologies;
    9         providing an effective date.
   10  
   11         WHEREAS, congenital heart defects are structural
   12  abnormalities of the heart which are present at birth.
   13  Congenital heart defects range in severity from simple problems,
   14  such as holes between chambers of the heart, to severe
   15  malformations, such as the complete absence of one or more
   16  chamber or valve. Some critical congenital heart defects can
   17  cause severe and life-threatening symptoms that require
   18  intervention within the first days of life, and
   19         WHEREAS, congenital heart defects are the leading cause of
   20  death of infants who have birth defects, and
   21         WHEREAS, according to the United States Secretary of Health
   22  and Human Services’ Advisory Committee on Heritable Disorders in
   23  Newborns and Children, congenital heart defects affect between
   24  seven and nine of every 1,000 live births in the United States
   25  and Europe, and
   26         WHEREAS, annual hospital costs in this country for all
   27  individuals who have congenital heart disease have reached $2.6
   28  billion, and
   29         WHEREAS, current methods for detecting congenital heart
   30  defects generally include prenatal ultrasound screening and
   31  repeated clinical examinations that can identify many affected
   32  newborns. These screenings identify less than half of all cases
   33  of critical congenital heart defects, and many of these heart
   34  defects are frequently missed during routine clinical exams
   35  performed before a newborn’s discharge from an ambulatory
   36  surgical center, hospital, or birth center, and
   37         WHEREAS, pulse oximetry is a noninvasive test that
   38  estimates the percentage of hemoglobin in blood which is
   39  saturated with oxygen. When pulse oximetry is performed on a
   40  newborn in a hospital or birth center, this test is effective in
   41  detecting critical, life-threatening congenital heart defects
   42  that otherwise go undetected by current screening methods, and
   43         WHEREAS, newborns who have abnormal pulse oximetry results
   44  require immediate confirmatory testing and intervention. Many
   45  newborn lives could potentially be saved by earlier detection
   46  and treatment of critical congenital heart defects if ambulatory
   47  surgical centers, hospitals, and birth centers in this state
   48  were required to perform the simple, noninvasive newborn
   49  screening in conjunction with current methods of screening for
   50  congenital heart defects, NOW THEREFORE,
   51  
   52  Be It Enacted by the Legislature of the State of Florida:
   53  
   54         Section 1. Subsection (2) of section 383.14, Florida
   55  Statutes, is amended to read:
   56         383.14 Screening for metabolic disorders, other hereditary
   57  and congenital disorders, and environmental risk factors.—
   58         (2) RULES.—After consultation with the Genetics and Newborn
   59  Screening Advisory Council, the department shall adopt and
   60  enforce rules requiring that every newborn in this state shall,
   61  before prior to becoming 1 week of age, be subjected to a test
   62  for phenylketonuria and, at the appropriate age, be tested for
   63  such other metabolic diseases and hereditary or congenital
   64  disorders as the department may deem necessary from time to
   65  time. The department shall also adopt and enforce rules that
   66  require each ambulatory surgical center and hospital, as defined
   67  in s. 395.002, and birth center, as defined in s. 383.302, which
   68  provides maternity and newborn care services in this state, to
   69  perform screening for critical congenital heart disease (CCHD)
   70  by testing for low blood-oxygen saturation using pulse oximetry
   71  or alternate peer-reviewed, evidence-based technologies on each
   72  newborn after the first 24 hours of life or before a newborn is
   73  discharged. After consultation with the Office of Early
   74  Learning, the department shall also adopt and enforce rules
   75  requiring every newborn in this state to be screened for
   76  environmental risk factors that place children and their
   77  families at risk for increased morbidity, mortality, and other
   78  negative outcomes. The department shall adopt such additional
   79  rules as are found necessary for the administration of this
   80  section and s. 383.145, including rules providing definitions of
   81  terms, rules relating to the methods used and time or times for
   82  testing as accepted medical practice indicates, rules relating
   83  to charging and collecting fees for the administration of the
   84  newborn screening program authorized by this section, rules for
   85  processing requests and releasing test and screening results,
   86  and rules requiring mandatory reporting of the results of tests
   87  and screenings for these conditions to the department.
   88         Section 2. This act shall take effect July 1, 2013.