As Introduced 1 123rd General Assembly 4 Regular Session H. B. No. 534 5 1999-2000 6 REPRESENTATIVES SALERNO-CALVERT-GOODMAN-KREBS-LOGAN-R. MILLER- 8 MOTTLEY-TERWILLEGER-VAN VYVEN-VERICH 9 _________________________________________________________________ 10 A B I L L To enact sections 3705.30, 3705.31, 3705.32, 12 3705.33, 3705.34, and 3705.35 of the Revised Code 13 to require the Director of Health to establish a 14 Birth Defects Information System and to repeal section 3705.34 four years after the effective 15 date of this act in compliance with agency sunset 16 provisions. BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 18 Section 1. That sections 3705.30, 3705.31, 3705.32, 20 3705.33, 3705.34, and 3705.35 of the Revised Code be enacted to 21 read as follows: Sec. 3705.30. THE DIRECTOR OF HEALTH SHALL ESTABLISH A 23 STATEWIDE BIRTH DEFECTS INFORMATION SYSTEM FOR THE COLLECTION OF 24 INFORMATION CONCERNING CONGENITAL ANOMALIES, STILLBIRTHS, AND 25 ABNORMAL CONDITIONS OF NEWBORNS. 26 (A) THE DIRECTOR MAY REQUIRE EACH HOSPITAL CLASSIFIED AS A 29 GENERAL HOSPITAL UNDER SECTION 3701.07 OF THE REVISED CODE AND 30 EACH FREESTANDING BIRTHING CENTER, AS DEFINED IN SECTION 3702.51 31 OF THE REVISED CODE, TO REPORT TO THE SYSTEM INFORMATION 32 CONCERNING ALL PATIENTS UNDER FIVE YEARS OF AGE WITH A PRIMARY 33 DIAGNOSIS OF A CONGENITAL ANOMALY OR ABNORMAL CONDITION. 34 (B) ON REQUEST, EACH GENERAL HOSPITAL AND FREESTANDING 36 BIRTHING CENTER SHALL GIVE THE DIRECTOR OR APPROPRIATE EMPLOYEES 38 OF THE DEPARTMENT OF HEALTH ACCESS TO THE MEDICAL RECORDS OF ANY 39 PATIENT DESCRIBED IN DIVISION (A) OF THIS SECTION. THE 40 2 DEPARTMENT SHALL PAY THE COSTS OF COPYING ANY MEDICAL RECORDS 41 PURSUANT TO THIS DIVISION. 42 (C) THE DIRECTOR MAY REVIEW VITAL STATISTICS RECORDS AND 44 SHALL CONSIDER EXPANDING THE LIST OF CONGENITAL ANOMALIES AND 45 ABNORMAL CONDITIONS OF NEWBORNS REPORTED ON BIRTH CERTIFICATES 46 PURSUANT TO SECTION 3705.08 OF THE REVISED CODE. 47 (D) A HOSPITAL OR BIRTHING CENTER THAT PROVIDES 49 INFORMATION TO THE SYSTEM PURSUANT TO THIS SECTION SHALL NOT BE 50 SUBJECT TO CRIMINAL OR CIVIL LIABILITY FOR PROVIDING THE 52 INFORMATION. Sec. 3705.31. THE BIRTH DEFECTS INFORMATION SYSTEM 54 ESTABLISHED UNDER SECTION 3705.30 OF THE REVISED CODE MAY BE USED 55 FOR ALL OF THE FOLLOWING PURPOSES: 57 (A) TO IDENTIFY AND DESCRIBE CONGENITAL ANOMALIES, 59 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 60 (B) TO DETECT TRENDS AND EPIDEMICS IN CONGENITAL 62 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 63 (C) TO QUANTIFY MORBIDITY AND MORTALITY OF CONGENITAL 65 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 66 (D) TO STIMULATE EPIDEMIOLOGICAL RESEARCH REGARDING 68 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 69 NEWBORNS; (E) TO IDENTIFY RISK FACTORS FOR CONGENITAL ANOMALIES, 71 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 72 (F) TO FACILITATE INTERVENTION IN AND PREVENTION OF 74 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 75 NEWBORNS; (G) TO FACILITATE ACCESS TO TREATMENT FOR CONGENITAL 77 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 78 (H) TO INFORM AND EDUCATE THE PUBLIC ABOUT CONGENITAL 80 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS. 81 Sec. 3705.32. (A) EXCEPT AS PROVIDED IN THIS SECTION, 83 INFORMATION ASSEMBLED BY THE BIRTH DEFECTS INFORMATION SYSTEM 84 PURSUANT TO SECTION 3705.30 OF THE REVISED CODE IS CONFIDENTIAL. 85 3 (B)(1) THE DIRECTOR OF HEALTH MAY USE INFORMATION 87 ASSEMBLED BY THE SYSTEM TO NOTIFY PARENTS, GUARDIANS, AND 88 CUSTODIANS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL 89 CONDITIONS OF MEDICAL CARE AND OTHER SERVICES AVAILABLE FOR THE 90 CHILD AND FAMILY. 91 (2) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 93 SYSTEM WITH THE WRITTEN CONSENT OF THE PARENT OR LEGAL GUARDIAN 94 OF THE CHILD WHO IS THE SUBJECT OF THE INFORMATION. 95 (C)(1) ACCESS TO INFORMATION ASSEMBLED BY THE SYSTEM SHALL 97 BE LIMITED TO THE FOLLOWING PERSONS AND GOVERNMENT ENTITIES: 98 (a) THE DIRECTOR OF HEALTH; 100 (b) APPROPRIATE EMPLOYEES OF THE DEPARTMENT OF HEALTH; 102 (c) QUALIFIED PERSONS OR GOVERNMENT ENTITIES THAT ARE 104 ENGAGED IN DEMOGRAPHIC, EPIDEMIOLOGICAL, OR SIMILAR STUDIES 105 RELATED TO HEALTH AND HEALTH CARE PROVISION. 106 (2) THE DIRECTOR SHALL GIVE A PERSON OR GOVERNMENT ENTITY 109 DESCRIBED IN DIVISION (C)(1)(c) OF THIS SECTION ACCESS TO THE 110 SYSTEM ONLY IF THE PERSON OR A REPRESENTATIVE OF THE PERSON OR 111 GOVERNMENT ENTITY SIGNS AN AGREEMENT TO MAINTAIN THE SYSTEM'S 112 CONFIDENTIALITY. (3) THE DIRECTOR SHALL MAINTAIN A RECORD OF ALL PERSONS 114 AND GOVERNMENT ENTITIES GIVEN ACCESS TO THE INFORMATION IN THE 115 SYSTEM THE RECORD SHALL INCLUDE ALL OF THE FOLLOWING INFORMATION: 116 (a) THE NAME OF THE PERSON WHO AUTHORIZED ACCESS TO THE 118 SYSTEM; 119 (b) THE NAME, TITLE, AND ORGANIZATIONAL AFFILIATION OF THE 121 PERSON OR GOVERNMENT ENTITY GIVEN ACCESS TO THE SYSTEM; 122 (c) THE DATES THE PERSON OR GOVERNMENT ENTITY WAS GIVEN 124 ACCESS TO THE SYSTEM; 125 (d) THE SPECIFIC PURPOSE FOR WHICH THE PERSON OR 127 GOVERNMENT ENTITY INTENDS TO USE THE INFORMATION. 129 (4) THE RECORD MAINTAINED PURSUANT TO DIVISION (C)(3) OF 131 THIS SECTION IS A PUBLIC RECORD, AS DEFINED IN SECTION 149.43 OF 132 THE REVISED CODE. 133 4 (5) A PERSON WHO VIOLATES AN AGREEMENT DESCRIBED IN 135 DIVISION (C)(2) OF THIS SECTION MAY BE DENIED FURTHER ACCESS TO 136 CONFIDENTIAL INFORMATION MAINTAINED BY THE DIRECTOR. 137 (D) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 139 SYSTEM IN SUMMARY, STATISTICAL, OR OTHER FORM THAT DOES NOT 140 IDENTIFY PARTICULAR INDIVIDUALS OR INDIVIDUAL SOURCES OF 141 INFORMATION. Sec. 3705.33. A CHILD'S PARENT OR LEGAL GUARDIAN WHO WANTS 143 INFORMATION CONCERNING THE CHILD REMOVED FROM THE BIRTH DEFECTS 144 INFORMATION SYSTEM SHALL REQUEST FROM THE CHILD'S PHYSICIAN A 145 FORM PREPARED BY THE DIRECTOR OF HEALTH. ON REQUEST, A PHYSICIAN 146 SHALL PROVIDE THE FORM TO THE CHILD'S PARENT OR LEGAL GUARDIAN 147 AND DISCUSS WITH THE CHILD'S PARENT OR LEGAL GUARDIAN THE 148 INFORMATION CONTAINED IN THE SYSTEM. IF THE CHILD'S PARENT OR 149 LEGAL GUARDIAN SIGNS THE FORM, THE PHYSICIAN SHALL FORWARD IT TO 150 THE DIRECTOR. ON RECEIPT OF THE SIGNED FORM, THE DIRECTOR SHALL 151 REMOVE ALL INFORMATION CONCERNING THE CHILD FROM THE SYSTEM. 152 Sec. 3705.34. THE DIRECTOR OF HEALTH SHALL APPOINT A 154 COUNCIL TO ADVISE ON THE IMPLEMENTATION OF THE BIRTH DEFECTS 155 INFORMATION SYSTEM. 156 (A) THE COUNCIL SHALL INCLUDE, AT A MINIMUM, PERSONS 158 REPRESENTING EACH OF THE FOLLOWING INTERESTS: 159 (1) OBSTETRICS AND GYNECOLOGY; 161 (2) PEDIATRICS; 163 (3) GENETICS; 165 (4) EPIDEMIOLOGY; 167 (5) BIOSTATISTICS; 169 (6) HOSPITAL ADMINISTRATION; 171 (7) THE DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL 173 DISABILITIES; 174 (8) THE DEPARTMENT OF EDUCATION; 176 (9) THE DEPARTMENT OF HUMAN SERVICES; 178 (10) PARENTS OF CHILDREN WITH CONGENITAL ANOMALIES OR 180 ABNORMAL CONDITIONS; 181 5 (11) THE PUBLIC. 183 (B)(1) THE COUNCIL SHALL CONVENE FOR ITS FIRST MEETING NO 185 LATER THAN THIRTY DAYS AFTER THE EFFECTIVE DATE OF THIS SECTION. 187 IN CONSULTATION WITH AND WITH THE APPROVAL OF THE COUNCIL, THE 188 DIRECTOR SHALL APPOINT, AT THE FIRST MEETING OF THE COUNCIL, THE 189 CHAIRPERSON AND VICE-CHAIRPERSON OF THE COUNCIL FROM AMONG THE 190 MEMBERS OF THE COUNCIL. THE CHAIRPERSON MAY CALL ADDITIONAL 191 MEETINGS AS THE CHAIRPERSON CONSIDERS APPROPRIATE. 192 (2) THE COUNCIL MAY ESTABLISH RULES OF PROCEDURE AS 194 NECESSARY TO FACILITATE THE COUNCIL'S ORDERLY CONDUCT OF 195 BUSINESS. (3) COUNCIL MEMBERS SHALL SERVE WITHOUT COMPENSATION BUT 197 SHALL BE REIMBURSED FOR THEIR ACTUAL AND NECESSARY EXPENSES 198 INCURRED IN THE PERFORMANCE OF THEIR DUTIES. 199 (C) THE COUNCIL SHALL RECOMMEND TO THE DIRECTOR A LIST OF 202 CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM. 203 Sec. 3705.35. WITHIN NINETY DAYS AFTER THE EFFECTIVE DATE 205 OF THIS SECTION, THE DIRECTOR OF HEALTH SHALL ADOPT RULES IN 206 ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE TO DO ALL OF THE 208 FOLLOWING: (A) IMPLEMENT THE BIRTH DEFECTS INFORMATION SYSTEM; 210 (B) SPECIFY THE TYPES OF CONGENITAL ANOMALIES AND ABNORMAL 212 CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM UNDER SECTION 213 3705.30 OF THE REVISED CODE; 214 (C) ESTABLISH REPORTING REQUIREMENTS FOR INFORMATION 216 CONCERNING DIAGNOSED CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS 217 OF NEWBORNS; 218 (D) ESTABLISH STANDARDS THAT MUST BE MET BY PERSONS OR 220 GOVERNMENT ENTITIES THAT SEEK ACCESS TO THE SYSTEM; 221 (E) ESTABLISH A FORM FOR USE BY PARENTS OR LEGAL GUARDIANS 223 WHO SEEK TO HAVE INFORMATION REGARDING THEIR CHILDREN REMOVED 224 FROM THE SYSTEM AND A METHOD OF DISTRIBUTING THE FORM TO 225 PHYSICIANS. 6 Section 2. That section 3705.34 of the Revised Code is 227 hereby repealed, effective four years after the effective date of 228 this act. 229