As Passed by the House 1 123rd General Assembly 4 Regular Session Sub. H. B. No. 534 5 1999-2000 6 REPRESENTATIVES SALERNO-CALVERT-GOODMAN-KREBS-LOGAN-R. MILLER- 8 MOTTLEY-TERWILLEGER-VAN VYVEN-VERICH-BARNES-GARDNER-VESPER- 9 WILLAMOWSKI-WOMER BENJAMIN-TIBERI-SULLIVAN-DePIERO-BENDER- 10 METELSKY-EVANS-FLANNERY-WINKLER-O'BRIEN-PERRY-WILSON-CLANCY- 11 KRUPINSKI-D. MILLER-DISTEL-PATTON-JERSE-KILBANE-BRITTON- 12 HARTNETT-METZGER-HOOPS-GOODING-JOLIVETTE-STEVENS-FORD-SUTTON- 13 REDFERN-GERBERRY-ROBINSON-MYERS-AUSTRIA-OLMAN-METTLER-HARRIS 14 _________________________________________________________________ 15 A B I L L To enact sections 3705.30, 3705.31, 3705.32, 17 3705.33, 3705.34, and 3705.35 of the Revised Code 18 to require the Director of Health to establish a 19 Birth Defects Information System and to repeal section 3705.34 four years after the effective 20 date of this act in compliance with agency sunset 21 provisions. BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 23 Section 1. That sections 3705.30, 3705.31, 3705.32, 25 3705.33, 3705.34, and 3705.35 of the Revised Code be enacted to 26 read as follows: Sec. 3705.30. (A) AS USED IN THIS SECTION: 29 (1) "FREESTANDING BIRTHING CENTER" HAS THE SAME MEANING AS 31 IN SECTION 3702.51 OF THE REVISED CODE. 32 (2) "HOSPITAL" MEANS A HOSPITAL CLASSIFIED UNDER SECTION 35 3701.07 OF THE REVISED CODE AS A GENERAL HOSPITAL OR CHILDREN'S 36 HOSPITAL. (3) "PHYSICIAN" MEANS AN INDIVIDUAL AUTHORIZED UNDER 38 CHAPTER 4731. OF THE REVISED CODE TO PRACTICE MEDICINE AND 39 SURGERY OR OSTEOPATHIC MEDICINE AND SURGERY. 41 2 (B) THE DIRECTOR OF HEALTH SHALL ESTABLISH AND, IF FUNDS 44 FOR THIS PURPOSE ARE AVAILABLE, IMPLEMENT A STATEWIDE BIRTH 45 DEFECTS INFORMATION SYSTEM FOR THE COLLECTION OF INFORMATION 47 CONCERNING CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL 48 CONDITIONS OF NEWBORNS. (C) IF THE SYSTEM IS IMPLEMENTED UNDER DIVISION (B) OF 50 THIS SECTION, ALL OF THE FOLLOWING APPLY: 51 (1) THE DIRECTOR MAY REQUIRE EACH PHYSICIAN, HOSPITAL, AND 55 FREESTANDING BIRTHING CENTER TO REPORT TO THE SYSTEM INFORMATION 58 CONCERNING ALL PATIENTS UNDER FIVE YEARS OF AGE WITH A PRIMARY 59 DIAGNOSIS OF A CONGENITAL ANOMALY OR ABNORMAL CONDITION. THE 61 DIRECTOR SHALL NOT REQUIRE A HOSPITAL OR FREESTANDING BIRTHING 62 CENTER TO REPORT TO THE SYSTEM ANY INFORMATION THAT IS REPORTED 63 TO THE DIRECTOR OR DEPARTMENT OF HEALTH UNDER ANOTHER PROVISION 64 OF THE REVISED CODE OR ADMINISTRATIVE CODE. 66 (2) ON REQUEST, EACH PHYSICIAN, HOSPITAL, AND FREESTANDING 68 BIRTHING CENTER SHALL GIVE THE DIRECTOR OR AUTHORIZED EMPLOYEES 70 OF THE DEPARTMENT OF HEALTH ACCESS TO THE MEDICAL RECORDS OF ANY 71 PATIENT DESCRIBED IN DIVISION (C)(1) OF THIS SECTION. THE 72 DEPARTMENT SHALL PAY THE COSTS OF COPYING ANY MEDICAL RECORDS 73 PURSUANT TO THIS DIVISION. 74 (3) THE DIRECTOR MAY REVIEW VITAL STATISTICS RECORDS AND 76 SHALL CONSIDER EXPANDING THE LIST OF CONGENITAL ANOMALIES AND 77 ABNORMAL CONDITIONS OF NEWBORNS REPORTED ON BIRTH CERTIFICATES 78 PURSUANT TO SECTION 3705.08 OF THE REVISED CODE. 79 (D) A PHYSICIAN, HOSPITAL, OR FREESTANDING BIRTHING CENTER 81 THAT PROVIDES INFORMATION TO THE SYSTEM UNDER DIVISION (C) OF 83 THIS SECTION SHALL NOT BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY 85 FOR PROVIDING THE INFORMATION. 86 Sec. 3705.31. IF IMPLEMENTED UNDER SECTION 3705.30 OF THE 88 REVISED CODE, THE BIRTH DEFECTS INFORMATION SYSTEM MAY BE USED 90 FOR ALL OF THE FOLLOWING PURPOSES: 92 (A) TO IDENTIFY AND DESCRIBE CONGENITAL ANOMALIES, 94 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 95 3 (B) TO DETECT TRENDS AND EPIDEMICS IN CONGENITAL 97 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 98 (C) TO QUANTIFY MORBIDITY AND MORTALITY OF CONGENITAL 100 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 101 (D) TO STIMULATE EPIDEMIOLOGICAL RESEARCH REGARDING 103 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 104 NEWBORNS; (E) TO IDENTIFY RISK FACTORS FOR CONGENITAL ANOMALIES, 106 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 107 (F) TO FACILITATE INTERVENTION IN AND PREVENTION OF 109 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 110 NEWBORNS; (G) TO FACILITATE ACCESS TO TREATMENT FOR CONGENITAL 112 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 113 (H) TO INFORM AND EDUCATE THE PUBLIC ABOUT CONGENITAL 115 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS. 116 Sec. 3705.32. (A) EXCEPT AS PROVIDED IN THIS SECTION AND 118 DIVISION (C)(2) OF SECTION 3705.30 OF THE REVISED CODE, RECORDS 120 RECEIVED AND INFORMATION ASSEMBLED BY THE BIRTH DEFECTS INFORMATION SYSTEM PURSUANT TO SECTION 3705.30 OF THE REVISED 122 CODE ARE CONFIDENTIAL MEDICAL RECORDS. 123 (B)(1) THE DIRECTOR OF HEALTH MAY USE INFORMATION 125 ASSEMBLED BY THE SYSTEM TO NOTIFY PARENTS, GUARDIANS, AND 126 CUSTODIANS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL 127 CONDITIONS OF MEDICAL CARE AND OTHER SERVICES AVAILABLE FOR THE 128 CHILD AND FAMILY. 129 (2) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 131 SYSTEM WITH THE WRITTEN CONSENT OF THE PARENT OR LEGAL GUARDIAN 132 OF THE CHILD WHO IS THE SUBJECT OF THE INFORMATION. 133 (C)(1) ACCESS TO INFORMATION ASSEMBLED BY THE SYSTEM SHALL 135 BE LIMITED TO THE FOLLOWING PERSONS AND GOVERNMENT ENTITIES: 136 (a) THE DIRECTOR OF HEALTH; 138 (b) AUTHORIZED EMPLOYEES OF THE DEPARTMENT OF HEALTH; 140 (c) QUALIFIED PERSONS OR GOVERNMENT ENTITIES THAT ARE 142 4 ENGAGED IN DEMOGRAPHIC, EPIDEMIOLOGICAL, OR SIMILAR STUDIES 143 RELATED TO HEALTH AND HEALTH CARE PROVISION. 144 (2) THE DIRECTOR SHALL GIVE A PERSON OR GOVERNMENT ENTITY 147 DESCRIBED IN DIVISION (C)(1)(c) OF THIS SECTION ACCESS TO THE 148 SYSTEM ONLY IF THE PERSON OR A REPRESENTATIVE OF THE PERSON OR 149 GOVERNMENT ENTITY SIGNS AN AGREEMENT TO MAINTAIN THE SYSTEM'S 150 CONFIDENTIALITY. (3) THE DIRECTOR SHALL MAINTAIN A RECORD OF ALL PERSONS 152 AND GOVERNMENT ENTITIES GIVEN ACCESS TO THE INFORMATION IN THE 153 SYSTEM. THE RECORD SHALL INCLUDE ALL OF THE FOLLOWING 154 INFORMATION: (a) THE NAME OF THE PERSON WHO AUTHORIZED ACCESS TO THE 156 SYSTEM; 157 (b) THE NAME, TITLE, AND ORGANIZATIONAL AFFILIATION OF THE 159 PERSON OR GOVERNMENT ENTITY GIVEN ACCESS TO THE SYSTEM; 160 (c) THE DATES THE PERSON OR GOVERNMENT ENTITY WAS GIVEN 162 ACCESS TO THE SYSTEM; 163 (d) THE SPECIFIC PURPOSE FOR WHICH THE PERSON OR 165 GOVERNMENT ENTITY INTENDS TO USE THE INFORMATION. 167 (4) THE RECORD MAINTAINED PURSUANT TO DIVISION (C)(3) OF 169 THIS SECTION IS A PUBLIC RECORD, AS DEFINED IN SECTION 149.43 OF 170 THE REVISED CODE. 171 (5) A PERSON WHO VIOLATES AN AGREEMENT DESCRIBED IN 173 DIVISION (C)(2) OF THIS SECTION MAY BE DENIED FURTHER ACCESS TO 174 CONFIDENTIAL INFORMATION MAINTAINED BY THE DIRECTOR. 175 (D) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 177 SYSTEM IN SUMMARY, STATISTICAL, OR OTHER FORM THAT DOES NOT 178 IDENTIFY PARTICULAR INDIVIDUALS OR INDIVIDUAL SOURCES OF 179 INFORMATION. Sec. 3705.33. AS USED IN THIS SECTION, "LOCAL HEALTH 183 DEPARTMENT" MEANS A HEALTH DEPARTMENT OPERATED BY THE BOARD OF 184 HEALTH OF A CITY OR GENERAL HEALTH DISTRICT OR THE AUTHORITY HAVING THE DUTIES OF A BOARD OF HEALTH UNDER SECTION 3709.05 OF 185 THE REVISED CODE. 186 5 A CHILD'S PARENT OR LEGAL GUARDIAN WHO WANTS INFORMATION 189 CONCERNING THE CHILD REMOVED FROM THE BIRTH DEFECTS INFORMATION 190 SYSTEM SHALL REQUEST FROM THE LOCAL HEALTH DEPARTMENT OR THE CHILD'S PHYSICIAN A FORM PREPARED BY THE DIRECTOR OF HEALTH. ON 192 REQUEST, A LOCAL HEALTH DEPARTMENT OR PHYSICIAN SHALL PROVIDE THE 194 FORM TO THE CHILD'S PARENT OR LEGAL GUARDIAN. THE INDIVIDUAL PROVIDING THE FORM SHALL DISCUSS WITH THE CHILD'S PARENT OR LEGAL 196 GUARDIAN THE INFORMATION CONTAINED IN THE SYSTEM. IF THE CHILD'S 197 PARENT OR LEGAL GUARDIAN SIGNS THE FORM, THE DEPARTMENT OR 198 PHYSICIAN SHALL FORWARD IT TO THE DIRECTOR. ON RECEIPT OF THE 199 SIGNED FORM, THE DIRECTOR SHALL REMOVE ALL INFORMATION CONCERNING 200 THE CHILD FROM THE SYSTEM. Sec. 3705.34. NOT LATER THAN THIRTY DAYS AFTER THE 202 EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH SHALL 203 APPOINT A COUNCIL TO ADVISE ON THE ESTABLISHMENT AND 204 IMPLEMENTATION OF THE BIRTH DEFECTS INFORMATION SYSTEM. 206 (A) THE COUNCIL SHALL INCLUDE, AT A MINIMUM, PERSONS 208 REPRESENTING EACH OF THE FOLLOWING INTERESTS: 209 (1) OBSTETRICS AND GYNECOLOGY; 211 (2) PEDIATRICS; 213 (3) GENETICS; 215 (4) EPIDEMIOLOGY; 217 (5) BIOSTATISTICS; 219 (6) HOSPITAL ADMINISTRATION; 221 (7) THE DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL 223 DISABILITIES; 224 (8) THE DEPARTMENT OF EDUCATION; 226 (9) THE DEPARTMENT OF JOB AND FAMILY SERVICES; 228 (10) THE COMMISSION ON MINORITY HEALTH; 230 (11) PARENTS OF CHILDREN WITH CONGENITAL ANOMALIES OR 232 ABNORMAL CONDITIONS; 233 (12) THE PUBLIC. 235 (B)(1) NOT LATER THAN THIRTY DAYS AFTER THE INITIAL 239 APPOINTMENTS ARE MADE UNDER DIVISION (A) OF THIS SECTION, THE 240 6 DIRECTOR SHALL CONVENE THE FIRST MEETING OF THE COUNCIL. IN 242 CONSULTATION WITH AND WITH THE APPROVAL OF THE COUNCIL, THE 243 DIRECTOR SHALL APPOINT, AT THE FIRST MEETING OF THE COUNCIL, THE 244 CHAIRPERSON AND VICE-CHAIRPERSON OF THE COUNCIL FROM AMONG THE 245 MEMBERS OF THE COUNCIL. THE CHAIRPERSON MAY CALL ADDITIONAL 246 MEETINGS AS THE CHAIRPERSON CONSIDERS APPROPRIATE. 247 (2) THE COUNCIL MAY ESTABLISH RULES OF PROCEDURE AS 249 NECESSARY TO FACILITATE THE COUNCIL'S ORDERLY CONDUCT OF 250 BUSINESS. (3) COUNCIL MEMBERS SHALL SERVE WITHOUT COMPENSATION BUT, 252 TO THE EXTENT FUNDS ARE AVAILABLE, SHALL BE REIMBURSED FOR THEIR 254 ACTUAL AND NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF 255 THEIR DUTIES. (C) THE COUNCIL SHALL RECOMMEND TO THE DIRECTOR A LIST OF 258 CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM. 259 Sec. 3705.35. NOT LATER THAN ONE HUNDRED EIGHTY DAYS 261 AFTER THE EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH 263 SHALL, IN CONSULTATION WITH THE COUNCIL CREATED UNDER SECTION 264 3705.34 OF THE REVISED CODE, ADOPT RULES IN ACCORDANCE WITH 265 CHAPTER 119. OF THE REVISED CODE TO DO ALL OF THE FOLLOWING: 266 (A) IMPLEMENT THE BIRTH DEFECTS INFORMATION SYSTEM; 268 (B) SPECIFY THE TYPES OF CONGENITAL ANOMALIES AND ABNORMAL 270 CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM UNDER SECTION 271 3705.30 OF THE REVISED CODE; 272 (C) ESTABLISH REPORTING REQUIREMENTS FOR INFORMATION 274 CONCERNING DIAGNOSED CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS 275 OF NEWBORNS; 276 (D) ESTABLISH STANDARDS THAT MUST BE MET BY PERSONS OR 278 GOVERNMENT ENTITIES THAT SEEK ACCESS TO THE SYSTEM; 279 (E) ESTABLISH A FORM FOR USE BY PARENTS OR LEGAL GUARDIANS 281 WHO SEEK TO HAVE INFORMATION REGARDING THEIR CHILDREN REMOVED 282 FROM THE SYSTEM AND A METHOD OF DISTRIBUTING THE FORM TO LOCAL 283 HEALTH DEPARTMENTS, AS DEFINED IN SECTION 3705.33 OF THE REVISED 284 7 CODE, AND TO PHYSICIANS. Section 2. That section 3705.34 of the Revised Code is 286 hereby repealed, effective four years after the effective date of 287 this act. 288