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