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