As Reported by House Health, Retirement and Aging Committee 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 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. (A) AS USED IN THIS SECTION: 24 (1) "FREESTANDING BIRTHING CENTER" HAS THE SAME MEANING AS 26 IN SECTION 3702.51 OF THE REVISED CODE. 27 (2) "HOSPITAL" MEANS A HOSPITAL CLASSIFIED UNDER SECTION 30 3701.07 OF THE REVISED CODE AS A GENERAL HOSPITAL OR CHILDREN'S 31 HOSPITAL. (3) "PHYSICIAN" MEANS AN INDIVIDUAL AUTHORIZED UNDER 33 CHAPTER 4731. OF THE REVISED CODE TO PRACTICE MEDICINE AND 34 SURGERY OR OSTEOPATHIC MEDICINE AND SURGERY. 36 (B) THE DIRECTOR OF HEALTH SHALL ESTABLISH AND, IF FUNDS 39 FOR THIS PURPOSE ARE AVAILABLE, IMPLEMENT A STATEWIDE BIRTH 40 DEFECTS INFORMATION SYSTEM FOR THE COLLECTION OF INFORMATION 42 CONCERNING CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL 43 CONDITIONS OF NEWBORNS. 2 (C) IF THE SYSTEM IS IMPLEMENTED UNDER DIVISION (B) OF 45 THIS SECTION, ALL OF THE FOLLOWING APPLY: 46 (1) THE DIRECTOR MAY REQUIRE EACH PHYSICIAN, HOSPITAL, AND 50 FREESTANDING BIRTHING CENTER TO REPORT TO THE SYSTEM INFORMATION 53 CONCERNING ALL PATIENTS UNDER FIVE YEARS OF AGE WITH A PRIMARY 54 DIAGNOSIS OF A CONGENITAL ANOMALY OR ABNORMAL CONDITION. THE 56 DIRECTOR SHALL NOT REQUIRE A HOSPITAL OR FREESTANDING BIRTHING 57 CENTER TO REPORT TO THE SYSTEM ANY INFORMATION THAT IS REPORTED 58 TO THE DIRECTOR OR DEPARTMENT OF HEALTH UNDER ANOTHER PROVISION 59 OF THE REVISED CODE OR ADMINISTRATIVE CODE. 61 (2) ON REQUEST, EACH PHYSICIAN, HOSPITAL, AND FREESTANDING 63 BIRTHING CENTER SHALL GIVE THE DIRECTOR OR AUTHORIZED EMPLOYEES 65 OF THE DEPARTMENT OF HEALTH ACCESS TO THE MEDICAL RECORDS OF ANY 66 PATIENT DESCRIBED IN DIVISION (C)(1) OF THIS SECTION. THE 67 DEPARTMENT SHALL PAY THE COSTS OF COPYING ANY MEDICAL RECORDS 68 PURSUANT TO THIS DIVISION. 69 (3) THE DIRECTOR MAY REVIEW VITAL STATISTICS RECORDS AND 71 SHALL CONSIDER EXPANDING THE LIST OF CONGENITAL ANOMALIES AND 72 ABNORMAL CONDITIONS OF NEWBORNS REPORTED ON BIRTH CERTIFICATES 73 PURSUANT TO SECTION 3705.08 OF THE REVISED CODE. 74 (D) A PHYSICIAN, HOSPITAL, OR FREESTANDING BIRTHING CENTER 76 THAT PROVIDES INFORMATION TO THE SYSTEM UNDER DIVISION (C) OF 78 THIS SECTION SHALL NOT BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY 80 FOR PROVIDING THE INFORMATION. 81 Sec. 3705.31. IF IMPLEMENTED UNDER SECTION 3705.30 OF THE 83 REVISED CODE, THE BIRTH DEFECTS INFORMATION SYSTEM MAY BE USED 85 FOR ALL OF THE FOLLOWING PURPOSES: 87 (A) TO IDENTIFY AND DESCRIBE CONGENITAL ANOMALIES, 89 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 90 (B) TO DETECT TRENDS AND EPIDEMICS IN CONGENITAL 92 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 93 (C) TO QUANTIFY MORBIDITY AND MORTALITY OF CONGENITAL 95 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 96 (D) TO STIMULATE EPIDEMIOLOGICAL RESEARCH REGARDING 98 3 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 99 NEWBORNS; (E) TO IDENTIFY RISK FACTORS FOR CONGENITAL ANOMALIES, 101 STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS; 102 (F) TO FACILITATE INTERVENTION IN AND PREVENTION OF 104 CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF 105 NEWBORNS; (G) TO FACILITATE ACCESS TO TREATMENT FOR CONGENITAL 107 ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS; 108 (H) TO INFORM AND EDUCATE THE PUBLIC ABOUT CONGENITAL 110 ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS. 111 Sec. 3705.32. (A) EXCEPT AS PROVIDED IN THIS SECTION AND 113 DIVISION (C)(2) OF SECTION 3705.30 OF THE REVISED CODE, RECORDS 115 RECEIVED AND INFORMATION ASSEMBLED BY THE BIRTH DEFECTS INFORMATION SYSTEM PURSUANT TO SECTION 3705.30 OF THE REVISED 117 CODE ARE CONFIDENTIAL MEDICAL RECORDS. 118 (B)(1) THE DIRECTOR OF HEALTH MAY USE INFORMATION 120 ASSEMBLED BY THE SYSTEM TO NOTIFY PARENTS, GUARDIANS, AND 121 CUSTODIANS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL 122 CONDITIONS OF MEDICAL CARE AND OTHER SERVICES AVAILABLE FOR THE 123 CHILD AND FAMILY. 124 (2) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 126 SYSTEM WITH THE WRITTEN CONSENT OF THE PARENT OR LEGAL GUARDIAN 127 OF THE CHILD WHO IS THE SUBJECT OF THE INFORMATION. 128 (C)(1) ACCESS TO INFORMATION ASSEMBLED BY THE SYSTEM SHALL 130 BE LIMITED TO THE FOLLOWING PERSONS AND GOVERNMENT ENTITIES: 131 (a) THE DIRECTOR OF HEALTH; 133 (b) AUTHORIZED EMPLOYEES OF THE DEPARTMENT OF HEALTH; 135 (c) QUALIFIED PERSONS OR GOVERNMENT ENTITIES THAT ARE 137 ENGAGED IN DEMOGRAPHIC, EPIDEMIOLOGICAL, OR SIMILAR STUDIES 138 RELATED TO HEALTH AND HEALTH CARE PROVISION. 139 (2) THE DIRECTOR SHALL GIVE A PERSON OR GOVERNMENT ENTITY 142 DESCRIBED IN DIVISION (C)(1)(c) OF THIS SECTION ACCESS TO THE 143 SYSTEM ONLY IF THE PERSON OR A REPRESENTATIVE OF THE PERSON OR 144 4 GOVERNMENT ENTITY SIGNS AN AGREEMENT TO MAINTAIN THE SYSTEM'S 145 CONFIDENTIALITY. (3) THE DIRECTOR SHALL MAINTAIN A RECORD OF ALL PERSONS 147 AND GOVERNMENT ENTITIES GIVEN ACCESS TO THE INFORMATION IN THE 148 SYSTEM. THE RECORD SHALL INCLUDE ALL OF THE FOLLOWING 149 INFORMATION: (a) THE NAME OF THE PERSON WHO AUTHORIZED ACCESS TO THE 151 SYSTEM; 152 (b) THE NAME, TITLE, AND ORGANIZATIONAL AFFILIATION OF THE 154 PERSON OR GOVERNMENT ENTITY GIVEN ACCESS TO THE SYSTEM; 155 (c) THE DATES THE PERSON OR GOVERNMENT ENTITY WAS GIVEN 157 ACCESS TO THE SYSTEM; 158 (d) THE SPECIFIC PURPOSE FOR WHICH THE PERSON OR 160 GOVERNMENT ENTITY INTENDS TO USE THE INFORMATION. 162 (4) THE RECORD MAINTAINED PURSUANT TO DIVISION (C)(3) OF 164 THIS SECTION IS A PUBLIC RECORD, AS DEFINED IN SECTION 149.43 OF 165 THE REVISED CODE. 166 (5) A PERSON WHO VIOLATES AN AGREEMENT DESCRIBED IN 168 DIVISION (C)(2) OF THIS SECTION MAY BE DENIED FURTHER ACCESS TO 169 CONFIDENTIAL INFORMATION MAINTAINED BY THE DIRECTOR. 170 (D) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE 172 SYSTEM IN SUMMARY, STATISTICAL, OR OTHER FORM THAT DOES NOT 173 IDENTIFY PARTICULAR INDIVIDUALS OR INDIVIDUAL SOURCES OF 174 INFORMATION. Sec. 3705.33. AS USED IN THIS SECTION, "LOCAL HEALTH 178 DEPARTMENT" MEANS A HEALTH DEPARTMENT OPERATED BY THE BOARD OF 179 HEALTH OF A CITY OR GENERAL HEALTH DISTRICT OR THE AUTHORITY HAVING THE DUTIES OF A BOARD OF HEALTH UNDER SECTION 3709.05 OF 180 THE REVISED CODE. 181 A CHILD'S PARENT OR LEGAL GUARDIAN WHO WANTS INFORMATION 184 CONCERNING THE CHILD REMOVED FROM THE BIRTH DEFECTS INFORMATION 185 SYSTEM SHALL REQUEST FROM THE LOCAL HEALTH DEPARTMENT OR THE CHILD'S PHYSICIAN A FORM PREPARED BY THE DIRECTOR OF HEALTH. ON 187 REQUEST, A LOCAL HEALTH DEPARTMENT OR PHYSICIAN SHALL PROVIDE THE 189 5 FORM TO THE CHILD'S PARENT OR LEGAL GUARDIAN. THE INDIVIDUAL PROVIDING THE FORM SHALL DISCUSS WITH THE CHILD'S PARENT OR LEGAL 191 GUARDIAN THE INFORMATION CONTAINED IN THE SYSTEM. IF THE CHILD'S 192 PARENT OR LEGAL GUARDIAN SIGNS THE FORM, THE DEPARTMENT OR 193 PHYSICIAN SHALL FORWARD IT TO THE DIRECTOR. ON RECEIPT OF THE 194 SIGNED FORM, THE DIRECTOR SHALL REMOVE ALL INFORMATION CONCERNING 195 THE CHILD FROM THE SYSTEM. Sec. 3705.34. NOT LATER THAN THIRTY DAYS AFTER THE 197 EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH SHALL 198 APPOINT A COUNCIL TO ADVISE ON THE ESTABLISHMENT AND 199 IMPLEMENTATION OF THE BIRTH DEFECTS INFORMATION SYSTEM. 201 (A) THE COUNCIL SHALL INCLUDE, AT A MINIMUM, PERSONS 203 REPRESENTING EACH OF THE FOLLOWING INTERESTS: 204 (1) OBSTETRICS AND GYNECOLOGY; 206 (2) PEDIATRICS; 208 (3) GENETICS; 210 (4) EPIDEMIOLOGY; 212 (5) BIOSTATISTICS; 214 (6) HOSPITAL ADMINISTRATION; 216 (7) THE DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL 218 DISABILITIES; 219 (8) THE DEPARTMENT OF EDUCATION; 221 (9) THE DEPARTMENT OF JOB AND FAMILY SERVICES; 223 (10) THE COMMISSION ON MINORITY HEALTH; 225 (11) PARENTS OF CHILDREN WITH CONGENITAL ANOMALIES OR 227 ABNORMAL CONDITIONS; 228 (12) THE PUBLIC. 230 (B)(1) NOT LATER THAN THIRTY DAYS AFTER THE INITIAL 234 APPOINTMENTS ARE MADE UNDER DIVISION (A) OF THIS SECTION, THE 235 DIRECTOR SHALL CONVENE THE FIRST MEETING OF THE COUNCIL. IN 237 CONSULTATION WITH AND WITH THE APPROVAL OF THE COUNCIL, THE 238 DIRECTOR SHALL APPOINT, AT THE FIRST MEETING OF THE COUNCIL, THE 239 CHAIRPERSON AND VICE-CHAIRPERSON OF THE COUNCIL FROM AMONG THE 240 MEMBERS OF THE COUNCIL. THE CHAIRPERSON MAY CALL ADDITIONAL 241 6 MEETINGS AS THE CHAIRPERSON CONSIDERS APPROPRIATE. 242 (2) THE COUNCIL MAY ESTABLISH RULES OF PROCEDURE AS 244 NECESSARY TO FACILITATE THE COUNCIL'S ORDERLY CONDUCT OF 245 BUSINESS. (3) COUNCIL MEMBERS SHALL SERVE WITHOUT COMPENSATION BUT, 247 TO THE EXTENT FUNDS ARE AVAILABLE, SHALL BE REIMBURSED FOR THEIR 249 ACTUAL AND NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF 250 THEIR DUTIES. (C) THE COUNCIL SHALL RECOMMEND TO THE DIRECTOR A LIST OF 253 CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM. 254 Sec. 3705.35. NOT LATER THAN ONE HUNDRED EIGHTY DAYS 256 AFTER THE EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH 258 SHALL, IN CONSULTATION WITH THE COUNCIL CREATED UNDER SECTION 259 3705.34 OF THE REVISED CODE, ADOPT RULES IN ACCORDANCE WITH 260 CHAPTER 119. OF THE REVISED CODE TO DO ALL OF THE FOLLOWING: 261 (A) IMPLEMENT THE BIRTH DEFECTS INFORMATION SYSTEM; 263 (B) SPECIFY THE TYPES OF CONGENITAL ANOMALIES AND ABNORMAL 265 CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM UNDER SECTION 266 3705.30 OF THE REVISED CODE; 267 (C) ESTABLISH REPORTING REQUIREMENTS FOR INFORMATION 269 CONCERNING DIAGNOSED CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS 270 OF NEWBORNS; 271 (D) ESTABLISH STANDARDS THAT MUST BE MET BY PERSONS OR 273 GOVERNMENT ENTITIES THAT SEEK ACCESS TO THE SYSTEM; 274 (E) ESTABLISH A FORM FOR USE BY PARENTS OR LEGAL GUARDIANS 276 WHO SEEK TO HAVE INFORMATION REGARDING THEIR CHILDREN REMOVED 277 FROM THE SYSTEM AND A METHOD OF DISTRIBUTING THE FORM TO LOCAL 278 HEALTH DEPARTMENTS, AS DEFINED IN SECTION 3705.33 OF THE REVISED 279 CODE, AND TO PHYSICIANS. Section 2. That section 3705.34 of the Revised Code is 281 hereby repealed, effective four years after the effective date of 282 this act. 283