Florida Senate - 2013 COMMITTEE AMENDMENT Bill No. SB 124 Barcode 630148 LEGISLATIVE ACTION Senate . House Comm: RCS . 02/06/2013 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Sobel) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Subsection (2) of section 383.14, Florida 6 Statutes, is amended to read: 7 383.14 Screening for metabolic disorders, other hereditary 8 and congenital disorders, and environmental risk factors.— 9 (2) RULES.—After consultation with the Genetics and Newborn 10 Screening Advisory Council, the department shall adopt and 11 enforce rules requiring that every newborn in this state shall, 12 beforeprior tobecoming 1 week of age, be subjected to a test 13 for phenylketonuria and, at the appropriate age, be tested for 14 such other metabolic diseases and hereditary or congenital 15 disorders as the department may deem necessary from time to 16 time. The department shall also adopt and enforce rules that 17 require each ambulatory surgical center and hospital, as defined 18 in s. 395.002, and birth center, as defined in s. 383.302, which 19 provides maternity and newborn care services in this state, to 20 perform screening for critical congenital heart disease (CCHD) 21 by testing for low blood-oxygen saturation using pulse oximetry 22 or alternate peer-reviewed, evidence-based technologies on each 23 newborn after the first 24 hours of life or before a newborn is 24 discharged. After consultation with the Office of Early 25 Learning, the department shall also adopt and enforce rules 26 requiring every newborn in this state to be screened for 27 environmental risk factors that place children and their 28 families at risk for increased morbidity, mortality, and other 29 negative outcomes. The department shall adopt such additional 30 rules as are found necessary for the administration of this 31 section and s. 383.145, including rules providing definitions of 32 terms, rules relating to the methods used and time or times for 33 testing as accepted medical practice indicates, rules relating 34 to charging and collecting fees for the administration of the 35 newborn screening program authorized by this section, rules for 36 processing requests and releasing test and screening results, 37 and rules requiring mandatory reporting of the results of tests 38 and screenings for these conditions to the department. 39 Section 2. This act shall take effect July 1, 2013. 40 41 ================= T I T L E A M E N D M E N T ================ 42 And the title is amended as follows: 43 Delete everything before the enacting clause 44 and insert: 45 A bill to be entitled 46 An act relating to newborn screening for critical 47 congenital heart disease; amending s. 383.14, F.S.; 48 requiring the Department of Health to adopt and 49 enforce rules that require ambulatory surgical 50 centers, hospitals, and birth centers in this state to 51 conduct screening for critical congenital heart 52 defects in all newborns by using certain technologies; 53 providing an effective date. 54 55 WHEREAS, congenital heart defects are structural 56 abnormalities of the heart which are present at birth. 57 Congenital heart defects range in severity from simple problems, 58 such as holes between chambers of the heart, to severe 59 malformations, such as the complete absence of one or more 60 chamber or valve. Some critical congenital heart defects can 61 cause severe and life-threatening symptoms that require 62 intervention within the first days of life, and 63 WHEREAS, congenital heart defects are the leading cause of 64 death of infants who have birth defects, and 65 WHEREAS, according to the United States Secretary of Health 66 and Human Services’ Advisory Committee on Heritable Disorders in 67 Newborns and Children, congenital heart defects affect between 68 seven and nine of every 1,000 live births in the United States 69 and Europe, and 70 WHEREAS, annual hospital costs in this country for all 71 individuals who have congenital heart disease have reached $2.6 72 billion, and 73 WHEREAS, current methods for detecting congenital heart 74 defects generally include prenatal ultrasound screening and 75 repeated clinical examinations that can identify many affected 76 newborns. These screenings identify less than half of all cases 77 of critical congenital heart defects, and many of these heart 78 defects are frequently missed during routine clinical exams 79 performed before a newborn’s discharge from an ambulatory 80 surgical center, hospital, or birth center, and 81 WHEREAS, pulse oximetry is a noninvasive test that 82 estimates the percentage of hemoglobin in blood which is 83 saturated with oxygen. When pulse oximetry is performed on a 84 newborn in a hospital or birth center, this test is effective in 85 detecting critical, life-threatening congenital heart defects 86 that otherwise go undetected by current screening methods, and 87 WHEREAS, newborns who have abnormal pulse oximetry results 88 require immediate confirmatory testing and intervention. Many 89 newborn lives could potentially be saved by earlier detection 90 and treatment of critical congenital heart defects if ambulatory 91 surgical centers, hospitals, and birth centers in this state 92 were required to perform the simple, noninvasive newborn 93 screening in conjunction with current methods of screening for 94 congenital heart defects, NOW THEREFORE,