Florida Senate - 2012 CS for SB 1052 By the Committee on Health Regulation; and Senator Ring 588-02355-12 20121052c1 1 A bill to be entitled 2 An act relating to newborn screening for critical 3 congenital heart disease; creating s. 383.146, F.S.; 4 providing definitions; providing requirements for 5 screening newborns for critical congenital heart 6 disease; providing an exception; requiring that the 7 physician, midwife, or other person attending the 8 newborn maintain a record if the screening has not 9 been performed and attach a written objection signed 10 by the parent or guardian; requiring appropriate 11 documentation of the screening completion in the 12 medical record; requiring that each hospital and each 13 licensed birth center designate a lead physician and a 14 licensed health care provider, respectively, to 15 provide programmatic oversight for the screening; 16 requiring that the screening for critical congenital 17 heart disease be conducted on all newborns in 18 hospitals and birth centers in this state; authorizing 19 the Department of Health to adopt rules to administer 20 the screening program; providing powers and duties of 21 the department; providing an effective date. 22 23 WHEREAS, congenital heart disease is the most common birth 24 defect in infants, affecting 8 out of every 1,000 newborn 25 babies, and 26 WHEREAS, early detection of congenital heart disease is 27 crucial to the health of a newborn baby because, if the 28 condition goes undiagnosed, it can cause major problems later in 29 the child’s life, and 30 WHEREAS, pulse oximetry is a noninvasive method of 31 monitoring the oxygen level in the blood and is recommended as a 32 method of screening a patient for critical congenital heart 33 disease, and 34 WHEREAS, physical exertion and participation in sports can 35 cause excess stress on the heart and, if the disease is not 36 detected and is severe enough, participation in strenuous 37 activity can result in death, NOW, THEREFORE, 38 39 Be It Enacted by the Legislature of the State of Florida: 40 41 Section 1. Section 383.146, Florida Statutes, is created to 42 read: 43 383.146 Newborn screening for critical congenital heart 44 disease.— 45 (1) DEFINITIONS.—As used in this section, the term: 46 (a) “Department” means the Department of Health. 47 (b) “Newborn” means an age range from birth through 29 48 days. 49 (c) “Screening” means measuring blood oxygen saturation 50 using pulse oximetry to determine whether a newborn needs 51 additional diagnostic evaluation for critical congenital heart 52 disease. 53 (2) REQUIREMENTS FOR SCREENING OF NEWBORNS; REFERRAL FOR 54 ONGOING SERVICES.— 55 (a) Each licensed hospital that provides maternity and 56 newborn care services shall ensure that, prior to discharge, all 57 newborns are screened for the detection of critical congenital 58 heart disease. 59 (b) Each licensed birth center that provides maternity and 60 newborn care services shall ensure that, prior to discharge, all 61 newborns are screened for the detection of critical congenital 62 heart disease. 63 (c) If the parent or legal guardian of the newborn objects 64 to the screening, the screening must not be completed, 65 notwithstanding any other provision of this section. In such 66 case, the physician, midwife, or other person who is attending 67 the newborn shall maintain a record that the screening has not 68 been performed and attach a written objection that must be 69 signed by the parent or guardian. 70 (d) For home births, the health care provider in attendance 71 is responsible for the screening. 72 (e) Appropriate documentation of the screening completion, 73 results, interpretation, and recommendations must be placed in 74 the medical record within 24 hours after completion of the 75 screening procedure. 76 (f) Each hospital shall formally designate a lead physician 77 who is responsible for programmatic oversight of newborn 78 congenital heart disease screening. Each licensed birth center 79 shall designate a licensed health care provider to provide such 80 programmatic oversight. Such physician or health care provider 81 shall ensure that the appropriate referrals are completed 82 following a positive screening test result. 83 (g) By October 1, 2012, screening for critical congenital 84 heart disease must be conducted on all newborns in hospitals and 85 birth centers in this state following birth admission. 86 (3) RULES.—After consultation with the Genetics and Newborn 87 Screening Advisory Council, the department shall adopt and 88 enforce rules requiring that every newborn in this state be 89 screened for critical congenital heart disease. The department 90 shall adopt such additional rules as are necessary for the 91 administration of this section, including rules providing 92 definitions of terms, rules relating to the methods used and 93 time or times for testing as accepted medical practice 94 indicates, rules relating to charging and collecting fees for 95 the administration of the newborn screening program required by 96 this section, rules for processing requests and releasing test 97 and screening results, and rules requiring mandatory reporting 98 of the results of tests and screenings for this condition to the 99 department. 100 (4) POWERS AND DUTIES OF THE DEPARTMENT.—The department 101 shall administer and provide services required pursuant to this 102 section and shall: 103 (a) Furnish to all physicians, county health departments, 104 perinatal centers, birth centers, and hospitals forms on which 105 the results of tests for critical congenital heart disease shall 106 be reported to the department. 107 (b) Have the authority to charge and collect fees 108 sufficient to administer the newborn screening program required 109 under this section. 110 Section 2. This act shall take effect July 1, 2012.