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