As Reported by the Senate Health, Human Services 2 and Aging Committee 2 123rd General Assembly 5 Regular Session Sub. H. B. No. 534 6 1999-2000 7 REPRESENTATIVES SALERNO-CALVERT-GOODMAN-KREBS-LOGAN-R. MILLER- 9 MOTTLEY-TERWILLEGER-VAN VYVEN-VERICH-BARNES-GARDNER-VESPER- 10 WILLAMOWSKI-WOMER BENJAMIN-TIBERI-SULLIVAN-DePIERO-BENDER- 11 METELSKY-EVANS-FLANNERY-WINKLER-O'BRIEN-PERRY-WILSON-CLANCY- 12 KRUPINSKI-D. MILLER-DISTEL-PATTON-JERSE-KILBANE-BRITTON- 13 HARTNETT-METZGER-HOOPS-GOODING-JOLIVETTE-STEVENS-FORD-SUTTON- 14 REDFERN-GERBERRY-ROBINSON-MYERS-AUSTRIA-OLMAN-METTLER-HARRIS- 15 SENATORS DRAKE-PRENTISS-HAGAN-ARMBRUSTER-SPADA 16 _________________________________________________________________ 18 A B I L L To enact sections 3705.30, 3705.31, 3705.32, 20 3705.33, 3705.34, 3705.35, and 3705.36 of the 21 Revised Code to require the Director of Health to establish a Birth Defects Information System and 22 to repeal section 3705.34 four years after the 23 effective date of this act in compliance with agency sunset provisions. 24 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 26 Section 1. That sections 3705.30, 3705.31, 3705.32, 28 3705.33, 3705.34, 3705.35, and 3705.36 of the Revised Code be 29 enacted to read as follows: 30 Sec. 3705.30. (A) AS USED IN THIS SECTION: 33 (1) "FREESTANDING BIRTHING CENTER" HAS THE SAME MEANING AS 35 IN SECTION 3702.51 OF THE REVISED CODE. 36 (2) "HOSPITAL" MEANS A HOSPITAL CLASSIFIED UNDER SECTION 39 3701.07 OF THE REVISED CODE AS A GENERAL HOSPITAL OR CHILDREN'S 40 HOSPITAL. (3) "PHYSICIAN" MEANS AN INDIVIDUAL AUTHORIZED UNDER 42 2 CHAPTER 4731. OF THE REVISED CODE TO PRACTICE MEDICINE AND 43 SURGERY OR OSTEOPATHIC MEDICINE AND SURGERY. 45 (B) THE DIRECTOR OF HEALTH SHALL ESTABLISH AND, IF FUNDS 48 FOR THIS PURPOSE ARE AVAILABLE, IMPLEMENT A STATEWIDE BIRTH 49 DEFECTS INFORMATION SYSTEM FOR THE COLLECTION OF INFORMATION 51 CONCERNING CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL 52 CONDITIONS OF NEWBORNS. (C) IF THE SYSTEM IS IMPLEMENTED UNDER DIVISION (B) OF 54 THIS SECTION, ALL OF THE FOLLOWING APPLY: 55 (1) THE DIRECTOR MAY REQUIRE EACH PHYSICIAN, HOSPITAL, AND 59 FREESTANDING BIRTHING CENTER TO REPORT TO THE SYSTEM INFORMATION 62 CONCERNING ALL PATIENTS UNDER FIVE YEARS OF AGE WITH A PRIMARY 63 DIAGNOSIS OF A CONGENITAL ANOMALY OR ABNORMAL CONDITION. THE 65 DIRECTOR SHALL NOT REQUIRE A HOSPITAL, FREESTANDING BIRTHING 66 CENTER, OR PHYSICIAN TO REPORT TO THE SYSTEM ANY INFORMATION THAT 68 IS REPORTED TO THE DIRECTOR OR DEPARTMENT OF HEALTH UNDER ANOTHER 69 PROVISION OF THE REVISED CODE OR ADMINISTRATIVE CODE. 71 (2) ON REQUEST, EACH PHYSICIAN, HOSPITAL, AND FREESTANDING 73 BIRTHING CENTER SHALL GIVE THE DIRECTOR OR AUTHORIZED EMPLOYEES 75 OF THE DEPARTMENT OF HEALTH ACCESS TO THE MEDICAL RECORDS OF ANY 76 PATIENT DESCRIBED IN DIVISION (C)(1) OF THIS SECTION. THE 77 DEPARTMENT SHALL PAY THE COSTS OF COPYING ANY MEDICAL RECORDS 78 PURSUANT TO THIS DIVISION. 79 (3) THE DIRECTOR MAY REVIEW VITAL STATISTICS RECORDS AND 81 SHALL CONSIDER EXPANDING THE LIST OF CONGENITAL ANOMALIES AND 82 ABNORMAL CONDITIONS OF NEWBORNS REPORTED ON BIRTH CERTIFICATES 83 PURSUANT TO SECTION 3705.08 OF THE REVISED CODE. 84 (D) A PHYSICIAN, HOSPITAL, OR FREESTANDING BIRTHING CENTER 86 THAT PROVIDES INFORMATION TO THE SYSTEM UNDER DIVISION (C) OF 88 THIS SECTION SHALL NOT BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY 90 FOR PROVIDING THE INFORMATION. 91 Sec. 3705.31. IF IMPLEMENTED UNDER SECTION 3705.30 OF THE 93 REVISED CODE, THE BIRTH DEFECTS INFORMATION SYSTEM MAY BE USED 95 FOR ALL OF THE FOLLOWING PURPOSES: 97 3 (A) TO IDENTIFY AND DESCRIBE CONGENITAL ANOMALIES, 99 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 100 (B) TO DETECT TRENDS AND EPIDEMICS IN CONGENITAL 102 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 103 (C) TO QUANTIFY MORBIDITY AND MORTALITY OF CONGENITAL 105 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 106 (D) TO STIMULATE EPIDEMIOLOGICAL RESEARCH REGARDING 108 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 109 NEWBORNS; (E) TO IDENTIFY RISK FACTORS FOR CONGENITAL ANOMALIES, 111 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 112 (F) TO FACILITATE INTERVENTION IN AND PREVENTION OF 114 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 115 NEWBORNS; (G) TO FACILITATE ACCESS TO TREATMENT FOR CONGENITAL 117 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 118 (H) TO INFORM AND EDUCATE THE PUBLIC ABOUT CONGENITAL 120 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS. 121 Sec. 3705.32. (A) EXCEPT AS PROVIDED IN THIS SECTION, 123 RECORDS RECEIVED AND INFORMATION ASSEMBLED BY THE BIRTH DEFECTS 124 INFORMATION SYSTEM PURSUANT TO SECTION 3705.30 OF THE REVISED 126 CODE ARE CONFIDENTIAL MEDICAL RECORDS. 127 (B)(1) THE DIRECTOR OF HEALTH MAY USE INFORMATION 129 ASSEMBLED BY THE SYSTEM TO NOTIFY PARENTS, GUARDIANS, AND 130 CUSTODIANS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL 131 CONDITIONS OF MEDICAL CARE AND OTHER SERVICES AVAILABLE FOR THE 132 CHILD AND FAMILY. 133 (2) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 135 SYSTEM WITH THE WRITTEN CONSENT OF THE PARENT OR LEGAL GUARDIAN 136 OF THE CHILD WHO IS THE SUBJECT OF THE INFORMATION. 137 (C)(1) ACCESS TO INFORMATION ASSEMBLED BY THE SYSTEM SHALL 139 BE LIMITED TO THE FOLLOWING PERSONS AND GOVERNMENT ENTITIES: 140 (a) THE DIRECTOR OF HEALTH; 142 (b) AUTHORIZED EMPLOYEES OF THE DEPARTMENT OF HEALTH; 144 4 (c) QUALIFIED PERSONS OR GOVERNMENT ENTITIES THAT ARE 146 ENGAGED IN DEMOGRAPHIC, EPIDEMIOLOGICAL, OR SIMILAR STUDIES 147 RELATED TO HEALTH AND HEALTH CARE PROVISION. 148 (2) THE DIRECTOR SHALL GIVE A PERSON OR GOVERNMENT ENTITY 151 DESCRIBED IN DIVISION (C)(1)(c) OF THIS SECTION ACCESS TO THE 152 SYSTEM ONLY IF THE PERSON OR A REPRESENTATIVE OF THE PERSON OR 153 GOVERNMENT ENTITY SIGNS AN AGREEMENT TO MAINTAIN THE SYSTEM'S 154 CONFIDENTIALITY. (3) THE DIRECTOR SHALL MAINTAIN A RECORD OF ALL PERSONS 156 AND GOVERNMENT ENTITIES GIVEN ACCESS TO THE INFORMATION IN THE 157 SYSTEM. THE RECORD SHALL INCLUDE ALL OF THE FOLLOWING 158 INFORMATION: (a) THE NAME OF THE PERSON WHO AUTHORIZED ACCESS TO THE 160 SYSTEM; 161 (b) THE NAME, TITLE, AND ORGANIZATIONAL AFFILIATION OF THE 163 PERSON OR GOVERNMENT ENTITY GIVEN ACCESS TO THE SYSTEM; 164 (c) THE DATES THE PERSON OR GOVERNMENT ENTITY WAS GIVEN 166 ACCESS TO THE SYSTEM; 167 (d) THE SPECIFIC PURPOSE FOR WHICH THE PERSON OR 169 GOVERNMENT ENTITY INTENDS TO USE THE INFORMATION. 171 (4) THE RECORD MAINTAINED PURSUANT TO DIVISION (C)(3) OF 173 THIS SECTION IS A PUBLIC RECORD, AS DEFINED IN SECTION 149.43 OF 174 THE REVISED CODE. 175 (5) A PERSON WHO VIOLATES AN AGREEMENT DESCRIBED IN 177 DIVISION (C)(2) OF THIS SECTION MAY BE DENIED FURTHER ACCESS TO 178 CONFIDENTIAL INFORMATION MAINTAINED BY THE DIRECTOR. 179 (D) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 181 SYSTEM IN SUMMARY, STATISTICAL, OR OTHER FORM THAT DOES NOT 182 IDENTIFY PARTICULAR INDIVIDUALS OR INDIVIDUAL SOURCES OF 183 INFORMATION. Sec. 3705.33. AS USED IN THIS SECTION, "LOCAL HEALTH 187 DEPARTMENT" MEANS A HEALTH DEPARTMENT OPERATED BY THE BOARD OF 188 HEALTH OF A CITY OR GENERAL HEALTH DISTRICT OR THE AUTHORITY HAVING THE DUTIES OF A BOARD OF HEALTH UNDER SECTION 3709.05 OF 189 5 THE REVISED CODE. 190 A CHILD'S PARENT OR LEGAL GUARDIAN WHO WANTS INFORMATION 193 CONCERNING THE CHILD REMOVED FROM THE BIRTH DEFECTS INFORMATION 194 SYSTEM SHALL REQUEST FROM THE LOCAL HEALTH DEPARTMENT OR THE CHILD'S PHYSICIAN A FORM PREPARED BY THE DIRECTOR OF HEALTH. ON 196 REQUEST, A LOCAL HEALTH DEPARTMENT OR PHYSICIAN SHALL PROVIDE THE 198 FORM TO THE CHILD'S PARENT OR LEGAL GUARDIAN. THE INDIVIDUAL PROVIDING THE FORM SHALL DISCUSS WITH THE CHILD'S PARENT OR LEGAL 200 GUARDIAN THE INFORMATION CONTAINED IN THE SYSTEM. IF THE CHILD'S 201 PARENT OR LEGAL GUARDIAN SIGNS THE FORM, THE DEPARTMENT OR 202 PHYSICIAN SHALL FORWARD IT TO THE DIRECTOR. ON RECEIPT OF THE 203 SIGNED FORM, THE DIRECTOR SHALL REMOVE FROM THE SYSTEM ANY INFORMATION THAT IDENTIFIES THE CHILD. 204 Sec. 3705.34. NOT LATER THAN THIRTY DAYS AFTER THE 206 EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH SHALL 207 APPOINT A COUNCIL TO ADVISE ON THE ESTABLISHMENT AND 208 IMPLEMENTATION OF THE BIRTH DEFECTS INFORMATION SYSTEM. 210 (A) THE COUNCIL SHALL INCLUDE, AT A MINIMUM, PERSONS 212 REPRESENTING EACH OF THE FOLLOWING INTERESTS: 213 (1) OBSTETRICS AND GYNECOLOGY; 215 (2) PEDIATRICS; 217 (3) GENETICS; 219 (4) EPIDEMIOLOGY; 221 (5) BIOSTATISTICS; 223 (6) HOSPITAL ADMINISTRATION; 225 (7) THE DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL 227 DISABILITIES; 228 (8) THE DEPARTMENT OF EDUCATION; 230 (9) THE DEPARTMENT OF JOB AND FAMILY SERVICES; 232 (10) THE COMMISSION ON MINORITY HEALTH; 234 (11) PARENTS OF CHILDREN WITH CONGENITAL ANOMALIES OR 236 ABNORMAL CONDITIONS; 237 (12) THE MARCH OF DIMES OHIO CHAPTER; 239 (13) THE PUBLIC. 241 6 (B)(1) NOT LATER THAN THIRTY DAYS AFTER THE INITIAL 245 APPOINTMENTS ARE MADE UNDER DIVISION (A) OF THIS SECTION, THE 246 DIRECTOR SHALL CONVENE THE FIRST MEETING OF THE COUNCIL. IN 248 CONSULTATION WITH AND WITH THE APPROVAL OF THE COUNCIL, THE 249 DIRECTOR SHALL APPOINT, AT THE FIRST MEETING OF THE COUNCIL, THE 250 CHAIRPERSON AND VICE-CHAIRPERSON OF THE COUNCIL FROM AMONG THE 251 MEMBERS OF THE COUNCIL. THE CHAIRPERSON MAY CALL ADDITIONAL 252 MEETINGS AS THE CHAIRPERSON CONSIDERS APPROPRIATE. 253 (2) THE COUNCIL MAY ESTABLISH RULES OF PROCEDURE AS 255 NECESSARY TO FACILITATE THE COUNCIL'S ORDERLY CONDUCT OF 256 BUSINESS. (3) COUNCIL MEMBERS SHALL SERVE WITHOUT COMPENSATION BUT, 258 TO THE EXTENT FUNDS ARE AVAILABLE, SHALL BE REIMBURSED FOR THEIR 260 ACTUAL AND NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF 261 THEIR DUTIES. (C) THE COUNCIL SHALL RECOMMEND TO THE DIRECTOR A LIST OF 264 CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM. 265 Sec. 3705.35. NOT LATER THAN ONE HUNDRED EIGHTY DAYS 267 AFTER THE EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH 269 SHALL, IN CONSULTATION WITH THE COUNCIL CREATED UNDER SECTION 270 3705.34 OF THE REVISED CODE, ADOPT RULES IN ACCORDANCE WITH 271 CHAPTER 119. OF THE REVISED CODE TO DO ALL OF THE FOLLOWING: 272 (A) IMPLEMENT THE BIRTH DEFECTS INFORMATION SYSTEM; 274 (B) SPECIFY THE TYPES OF CONGENITAL ANOMALIES AND ABNORMAL 276 CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM UNDER SECTION 277 3705.30 OF THE REVISED CODE; 278 (C) ESTABLISH REPORTING REQUIREMENTS FOR INFORMATION 280 CONCERNING DIAGNOSED CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS 281 OF NEWBORNS; 282 (D) ESTABLISH STANDARDS THAT MUST BE MET BY PERSONS OR 284 GOVERNMENT ENTITIES THAT SEEK ACCESS TO THE SYSTEM; 285 (E) ESTABLISH A FORM FOR USE BY PARENTS OR LEGAL GUARDIANS 287 WHO SEEK TO HAVE INFORMATION REGARDING THEIR CHILDREN REMOVED 288 7 FROM THE SYSTEM AND A METHOD OF DISTRIBUTING THE FORM TO LOCAL 289 HEALTH DEPARTMENTS, AS DEFINED IN SECTION 3705.33 OF THE REVISED 290 CODE, AND TO PHYSICIANS. THE METHOD OF DISTRIBUTION MUST INCLUDE 291 MAKING THE FORM AVAILABLE ON THE INTERNET. Sec. 3705.36. THREE YEARS AFTER THE DATE A BIRTH DEFECTS 293 INFORMATION SYSTEM IS IMPLEMENTED PURSUANT TO SECTION 3705.30 OF 294 THE REVISED CODE, AND ANNUALLY THEREAFTER, THE DEPARTMENT OF 295 HEALTH SHALL PREPARE A REPORT REGARDING THE BIRTH DEFECTS 296 INFORMATION SYSTEM. THE COUNCIL CREATED UNDER SECTION 3705.34 OF 297 THE REVISED CODE SHALL, NOT LATER THAN TWO YEARS AFTER THE DATE A 299 BIRTH DEFECTS INFORMATION SYSTEM IS IMPLEMENTED, SPECIFY THE 300 INFORMATION THE DEPARTMENT IS TO INCLUDE IN EACH REPORT. THE 301 DEPARTMENT SHALL FILE THE REPORT WITH THE GOVERNOR, THE PRESIDENT 302 AND MINORITY LEADER OF THE SENATE, THE SPEAKER AND MINORITY 303 LEADER OF THE HOUSE OF REPRESENTATIVES, THE DEPARTMENTS OF MENTAL 304 RETARDATION AND DEVELOPMENTAL DISABILITIES, EDUCATION, AND JOB 305 AND FAMILY SERVICES, THE COMMISSION ON MINORITY HEALTH, AND THE 306 NEWS MEDIA. Section 2. That section 3705.34 of the Revised Code is 308 hereby repealed, effective four years after the effective date of 309 this act. 310