Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”     VIDEO:   Narrator:    

AUDIO:   SINCE  1965,  THE  STATE  OF  TEXAS  HAS  BEEN  TESTING  THE  

-­‐Intro  shot  of  newborn  from  the  

BLOOD  OF  EVERY  NEWBORN  FOR  POTENTIALLY  DEVASTATING  

“Texas  Health  Steps:  Newborn  

GENETIC  DISORDERS.  TODAY,  ALL  STATES  IN  THE  U.  S.  REQUIRE  

Heelstick”  video  or  from  the    “Our  

NEWBORN  SCREENING.  THESE  BLOOD  TESTS  ARE  PERFORMED  

State  Health  Laboratory”  video    

ON  BLOOD  SPECIMENS  COLLECTED  IN  THE  HOSPITAL  AFTER  

-­‐Very  brief  clip  of  heelstick  footage  

BIRTH  AND  AGAIN  IN  THE  OFFICE  OR  CLINIC  OF  THE  BABY’S  

from  the  THSteps  NBS  video  or  DSHS  

HEALTH-­‐CARE  PROVIDER  AT  ONE  TO  TWO  WEEKS  OF  AGE.    

Lab  video   Interview  with  Dr.  Charleta  Guillory:  

“MANY  BABIES  WITH  THESE  GENETIC  DISORDERS  APPEAR  

-­‐on  camera  

HEALTHY  WHEN  BORN.  FINDING  THEM  EARLY  CAN  PREVENT   SERIOUS  ILLNESS,  MENTAL  OR  PHYSICAL  DISABILITIES,  OR  EARLY   DEATH.  EACH  YEAR,  THE  NEWBORN  SCREENING  PROGRAM   GIVES  HUNDREDS  OF  TEXAS  CHILDREN  A  CHANCE  FOR  A   RELATIVELY  NORMAL,  HEALTHY  LIFE.”    

Narrator:  

THE  TEXAS  NEWBORN  SCREENING  PANEL  INCLUDES  NEARLY  30  

-­‐Title  card  with  scrolling  list  of  

RARE  DISORDERS  AND  HEARING  SCREENING.  MANY  OF  THESE  

disorders    

RARE  DISORDERS  CAN  CAUSE  IRREPARABLE  DAMAGE  IN  THE   FIRST  DAYS  OF  LIFE.  IF  A  TEST  RESULT  IS  SUGGESTIVE  OF  A   DISORDER,  PROMPT  FOLLOW-­‐UP  IS  CRITICAL.  IN  SOME  CASES,   CHANGES  IN  DIET  AND/OR  OTHER  SIMPLE  INTERVENTIONS  CAN   PREVENT  LIFELONG  CONSEQUENCES.    

Narrator:   -

IN  NOVEMBER  OF  2006,  JESSIE  NEAL  WAS  BORN  IN  MARSHALL,  

Still  shots  of  infant  Jesse  Neal  

TEXAS.  TESTING  JESSIE’S  BLOOD  SAMPLES,  LAB  TECHNICIANS  

and  Mom  Christena  from  the  

DETECTED  A  POSSIBLE  MCAD  (EM-­‐CAD)  DEFICIENCY,  A  RARE  

DSHS  Lab  video  

GENETIC  DISORDER  THAT  IF  LEFT  UNTREATED  CAN  CAUSE  

 

SUDDEN  DEATH.  

 

 

Christena  on  camera  

“IT  NEVER  OCCURRED  TO  ME  THAT,  THAT  TEST  WOULD  SAVE  

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Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”      

HIS  LIFE.”    

Narrator:  

JUST  WEEKS  BEFORE  JESSIE’S  NEWBORN  SCREENING  SAMPLES  

-­‐  Baby  Jessie  

ARRIVED  AT  THE  DEPARTMENT  OF  STATE  HEALTH  SERVICES  

 

LABORATORY,  TESTING  WAS  DONE  FOR  JUST  SEVEN  GENETIC  

 

DISORDERS.  THE  DAY  JESSIE’S  BLOOD  SAMPLES  CAME  IN  WAS  

 

ONLY  THE  SECOND  DAY  THE  STATE  LABORATORY  HAD  BEGUN  

 

REPORTING  RESULTS  FOR  MCAD.    

  Christena  on  camera:  

 “IF  HE’D  HAVE  BEEN  BORN  A  WEEK  OR  TWO  EARLIER,  I  THINK  

 

THEY’D  HAVE  MISSED  HIM.  AND  IF  THEY  DID  NOT  CATCH  HIM,  

 

HIS  LEVELS  WERE  SO  HIGH,  HE’D  HAVE  DIED.”  

Narrator:  

BUT  JESSIE  GOT  A  SECOND  CHANCE,  AS  DO  THE  

-­‐  Baby  Jessie  

APPROXIMATELY  700  INFANTS  IN  TEXAS  WHO  ARE  DIAGNOSED  

 

EACH  YEAR  BY  CONFIRMATORY  TESTING  FOLLOWING  AN   ABNORMAL  NEWBORN  SCREEN.    

Narrator:  

THE  SCREENING  SPECIMENS  ARE  OBTAINED  BY  PRICKING  THE  

-­‐Clip  from  the  THSteps  NBS  video  

HEEL  OF  THE  NEWBORN  AND  PLACING  FIVE  BLOOD  SPOTS  ON  A  

(show  placing  the  blood  spots  on  the  

COLLECTION  CARD  MADE  OF  SPECIAL  FILTER  PAPER.    

circles)  

THE  BLOOD  SPOT  CARD  MUST  BE  SENT  TO  THE  STATE  

-­‐clip  of  the  DSHS  Health  lab  testing  

LABORATORY  WITHIN  24  HOURS  OF  COLLECTION  FOR  TESTING.    

the  blood  spot  cards  from    

 

the  DSHS  Lab  video  

IF  A  NEWBORN  SCREEN  SUGGESTS  A  DISORDER,  NURSING  

-­‐Clip  from  the  DSHS  Lab  video  

STAFF  WITH  THE  DEPARTMENT  OF  STATE  HEALTH  SERVICES’  

showing  case  management  nurse  

NEWBORN  SCREENING  PROGRAM  ARE  ALERTED,  AND  THEY  

calling  the  doctor  (comes  during  

IMMEDIATELY  CALL  THE  BABY’S  HEALTH-­‐CARE  PROVIDER  TO  

Jessie’s  segment)  

COORDINATE  CLINICAL  CARE.    

Morgan  Sanders,  March  of  Dimes  

 

Interview:  -­‐on  camera   Narrator:  

AFTER  THE  STATE  LABORATORY  HAS  FINISHED  TESTING,  THE  

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Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”     -­‐Short  clip  of  the  DSHS  Lab  scenes  

BLOOD  SPOTS  ARE  STORED  SAFELY  AND  CONFIDENTIALLY  BY  

from  the  DSHS  Lab  video  

THE  TEXAS  DEPARTMENT  OF  STATE  HEALTH  SERVICES.    

 

 

-­‐Dr.  Charleta  Guillory  –  Interview  on  

“THE  STORED  BLOOD  SPOTS  HAVE  BENEFICIAL  PUBLIC  HEALTH  

Camera  

USES  ONCE  NEWBORN  SCREENING  IS  COMPLETED.  THE  STATE  

 

LABORATORY  MAY  USE  SOME  OF  THE  STORED  BLOOD  SPOTS  

 

FOR  QUALITY  ASSURANCE  AND  QUALITY  CONTROL  TO  

 

MAINTAIN  CLINICAL  LABORATORY  IMPROVEMENT  ACT  (CLIA)  

 

OR  CLEAR  CERTIFICATION.  THIS  CERTIFICATION  IS  REQUIRED  TO  

 

PERFORM  NEWBORN  SCREENING  TESTS  AND  ENSURE  THE  

 

VALIDITY  OF  TEST  RESULTS.  (CLIA)  REQUIRES  SUCH  QA/QC  

 

ACTIVITIES.  STORED  SAMPLES  MAY  ALSO  BE  USED  TO  

 

EVALUATE  THE  NEWBORN  SCREENING  PROGRAM,  BOTH  FOR  

 

INTERNAL  REVIEW  AND  FOR  COMPARISON  WITH  OTHER  STATE  

 

PROGRAMS.  IN  ADDITION,  THE  STORED  BLOOD  SAMPLES  HAVE  

 

THE  POTENTIAL  TO  HELP  IMPROVE  NEWBORN  SCREENING  

 

TESTING  METHODS.  

 

 

 

“THE  STORED  SAMPLES  ALSO  HAVE  POTENTIAL  VALUE  FOR  THE  

 

CHILD  FROM  WHOM  THEY  WERE  COLLECTED.  FOR  INSTANCE,  

 

THE  CHILD’S  MEDICAL  PROVIDER  MAY  REQUEST  ADDITIONAL  

 

TESTING  ON  THE  REMAINING  SAMPLES.  YOU  ARE  ONLY  24  

 

HOURS  OLD  ONE  TIME  IN  YOUR  LIFE,  AND  YOUR  BLOOD  IS  VERY  

 

DIFFERENT  AT  THAT  TIME  THAN  AT  ANY  OTHER  AGE.  ”  

 

 

 

 

 

 

Narrator:  

IN  THE  LONG  TERM,  USING  THE  CONFIDENTIAL  AND  DE-­‐

-­‐More  video  of  the  DSHS  Health  lab  

IDENTIFIED  BLOOD  SPOTS  IN  MEDICAL  RESEARCH  COULD  HELP  

from  “Our  State  Health  Laboratory”  

IMPROVE  THE  HEALTH  OF  ALL  TEXAS  CHILDREN.  SCREENING  

 

BLOOD  SPOTS  MAY  BE  USED  IN  RESEARCH  TO  FIND  NEW  WAYS  

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Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”      

TO  DIAGNOSE  AND  TREAT  DISORDERS  AND  DISEASES.  THERE  

 

ARE  PRIVACY  SAFEGUARDS  IN  PLACE  FOR  SUCH  RESEARCH.  

 

MOST  IMPORTANTLY,  UNLESS  THE  PARENTS  OR  LEGAL  

 

GUARDIANS  GIVE  ADVANCE  WRITTEN  CONSENT,  RESEARCHERS  

 

ARE  NOT  ALLOWED  ACCESS  TO  ANY  INFORMATION  THAT  

 

WOULD  LINK  A  PARTICULAR  BLOOD  SPOT  TO  A  PARTICULAR  

 

CHILD  OR  THE  CHILD’S  FAMILY.  THE  DEPARTMENT  OF  STATE  

 

HEALTH  SERVICES  DOES  NOT  ALLOW  RELEASE  OF  BLOOD  SPOTS  

 

OR  ASSOCIATED  DATA  FOR  RESEARCH  USES  BY  EXTERNAL  

 

ENTITIES  UNLESS  THAT  RESEARCH  HAS  A  PUBLIC  HEALTH  

 

PURPOSE,  AND  CERTAIN  CONTROLS  ARE  IN  PLACE.    

 

 

 

RESEARCHERS  SEEKING  TO  USE  RESIDUAL  BLOOD  SPOTS  MUST  

 

SUBMIT  A  RESEARCH  PROTOCOL  FOR  REVIEW  BY  THE  

 

DEPARTMENT  OF  STATE  HEALTH  SERVICES  INSTITUTIONAL  

 

REVIEW  BOARD,  WHICH  IS  A  BODY  OF  SCIENTIFIC  AND  LEGAL  

 

EXPERTS  CHARGED  WITH  PROTECTING  THE  PRIVACY  RIGHTS  OF  

 

THE  PERSONS  FROM  WHICH  THE  SPECIMENS  CAME.  THIS  

 

REVIEW  BOARD  IS  GOVERNED  BY  FEDERAL  AND  STATE  LAW,  AS  

 

WELL  AS  AGENCY  POLICY,  TO  ENSURE  THAT  THE  PRIVACY  OF  

 

THE  INDIVIDUALS  IN  QUESTION  IS  PROTECTED.  ONLY  THOSE  

 

PUBLIC  HEALTH-­‐RELATED  RESEARCH  PROJECTS  THAT  ARE  

 

APPROVED  BY  AGENCY  MANAGEMENT  AND  THE  

 

INSTITUTIONAL  REVIEW  BOARD  MAY  GO  FORWARD  USING  

 

RESIDUAL  BLOOD  SPOTS  AND/OR  ASSOCIATED  DATA—AND  

 

THOSE  THAT  GO  FORWARD  MUST  ADHERE  TO  THE  APPROVED  

 

RESEARCH  PROTOCOL.  MEDICAL  PROVIDERS  MUST  GIVE  

 

PARENTS  THE  DISCLOSURE/DIRECTIVE  FORM  THAT  COMES  IN  

 

THE  NEWBORN  SCREENING  SPECIMEN  COLLECTION  KIT  AT  THE  

 

TIME  OF  EACH  NEWBORN  SCREENING  COLLECTION.  PROVIDERS  

 

ARE  NOT  REQUIRED  TO  ENSURE  THE  PARENTS  OR  LEGAL  

4    

 

Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”      

GUARDIANS  COMPLETE  AND  SIGN  THE  FORM;  THEY  ARE  ONLY  

 

REQUIRED  TO  ENSURE  THE  PARENTS  OR  GUARDIANS  RECEIVE  

 

THE  FORM.  USING  THE  FORM,  PARENTS  OR  LEGAL  GUARDIANS  

 

CAN  DIRECT  THE  DEPARTMENT  OF  STATE  HEALTH  SERVICES  TO  

-­‐Title  card  here  with  information  on  

DESTROY  THEIR  CHILD’S  BLOOD  SPOTS.  PARENTS  OR  

disclosure  full-­‐screen  

GUARDIANS  DECIDE  WHAT  CHOICE  TO  MAKE.  IF  THEY  CHOOSE  

 

NOT  TO  HAVE  THEIR  CHILD’S  BLOOD  SPOTS  DESTROYED,  THEY  

-­‐Show  actual  disclosure  form  

DO  NOT  NEED  TO  FILL  OUT  THE  FORM.  IF  THE  DEPARTMENT  IS  

(available  in  English  and  Spanish  

DIRECTED  TO  DESTROY  THE  CHILD’S  BLOOD  SPOTS,  THAT  WILL  

 

BE  DONE  AFTER  THE  SCREENING  ITSELF  TAKES  PLACE.  THE  

 

FORM  WILL  COVER  BOTH  SETS  OF  BLOOD  SPOTS  RECEIVED  FOR  

 

THAT  CHILD.  

 

 

 

THE  LAW  REQUIRES  PROVIDERS  TO  VERIFY  THAT  THE  FORM  

 

WAS  GIVEN  TO  THE  PARENTS  WHEN  THE  SPECIMEN  IS  

 

COLLECTED  BY  CHECKING  THE  INDICATED  BOX  LOCATED  ON  

 

THE  BLOOD  SPOT  CARD.  IF  THE  PARENT  CHOOSES  TO  SIGN  THE  

 

FORM,  AND  IF  THE  PROVIDER  AGREES  TO  SUBMIT  IT  TO  THE  

 

DEPARTMENT  OF  STATE  HEALTH  SERVICES  FOR  THE  PARENT,  

-­‐Show  heel  stick  collection  card  with  

THE  PROVIDER  MAY  DO  SO.  IF  NOT,  THEN  THE  PARENT  WOULD  

check  box  (from  11/2010  NBS  video  

BE  RESPONSIBLE  FOR  SENDING  THE  FORM  TO  THE  

update)  

DEPARTMENT.  IF  THE  PARENT  SUBMITS  THE  REQUEST,  

 

DESTRUCTION  WILL  TAKE  PLACE  WITHIN  60  DAYS  AFTER  THE  

 

REQUEST  IS  RECEIVED  OR  AFTER  THE  NEWBORN  SCREENING   TEST  IS  COMPLETED.  

 

THE  ISSUE  OF  WHAT  BLOOD  SPOT  USES  SHOULD  BE  ALLOWED  

 

AFTER  THE  SCREENING  TAKES  PLACE  HAS  BEEN  THE  SUBJECT  OF  

 

SOME  DISCUSSION  IN  TEXAS  IN  RECENT  YEARS,  AS  WELL  AS  IN  

 

OTHER  STATES  AND  INTERNATIONALLY.  SOME  PARENTS  HAVE  

 

VOICED  CONCERNS  ABOUT  HOW  A  CHILD’S  GENETIC  

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Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”      

INFORMATION  COULD  BE  USED  IN  THE  FUTURE.  FEDERAL  LAWS  

 

REGARDING  THE  PRIVACY  OF  PROTECTED  HEALTH  

 

INFORMATION,  AND  ALSO  REGARDING  RESEARCH  SUCH  AS  

 

THAT  USING  RESIDUAL  NEWBORN  SCREENING  BLOOD  SPOTS,  

 

HAVE  BEEN  IN  PLACE  FOR  MANY  YEARS.    

 

 

 

 

Show  the  text  of  HB  1672  from  the  

IN  2009,  THE  TEXAS  LEGISLATURE  ENACTED  NEW  LAWS  TO  

last  leg.  session  

STRENGTHEN  EXISTING  PRIVACY  PROTECTIONS,  ENSURE  THAT  

 

PARENTS  ARE  INFORMED  UP  FRONT  ABOUT  ALLOWABLE  USES  

 

OF  THE  BLOOD  SPOTS  UNDER  THE  LAW,  AND  TO  GIVE  PARENTS  

 

THE  OPTION  TO  HAVE  THEIR  CHILDREN’S  SPOTS  DESTROYED  

-­‐Clip  of  lab  technicians  working  from  

ONCE  THE  SCREENING  IS  COMPLETED.  THE  DEPARTMENT  OF  

the  DSHS  Lab  video  

STATE  HEALTH  SERVICES  HAS  FULLY  IMPLEMENTED  THESE  NEW  

 

STATE  LAWS,  INCLUDING  THE  ADOPTION  OF  NEW  AGENCY   POLICIES  TO  ADD  ADDITIONAL  LEVELS  OF  REVIEW  OF   PROPOSED  RESEARCH  STUDIES.  MORE  INFORMATION  ON   BLOOD  SPOT  USE  AND  STORAGE  POLICY  IS  LOCATED  ON  THE   DEPARTMENT  WEBSITE  AT   DSHS.STATE.TX.US/LAB/NBSBLOODSPOTS.SHTM.     THE  DEPARTMENT  IS  CONTINUALLY  TAKING  STEPS  TO  ENSURE   TRANSPARENCY  ABOUT  THE  USE  OF  THE  BLOOD  SPOTS  WHILE   EMPHASIZING  THEIR  IMPORTANCE  IN  PUBLIC  HEALTH.      

Dr.  Charleta  Guillory:  

“THE  TEXAS  DEPARTMENT  OF  STATE  HEALTH  SERVICES  IS  

-­‐on  camera  

COMMITTED  TO  PROTECTING  THE  PERSONAL  INFORMATION  OF   THE  CHILDREN  TESTED  IN  THE  NEWBORN  SCREENING   PROGRAM.  IF  A  CHILD’S  BLOOD  SPOT  IS  USED  FOR  RESEARCH,   NO  PERSONAL  INFORMATION  WILL  ACCOMPANY  THE  CHILD’S   BLOOD  SPOT,  UNLESS  IT’S  APPROVED  IN  WRITING  AND  IN  

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Texas  Health  Steps   “Newborn  Screening:  Disclosure  Webinar  For  Providers”    

ADVANCE  BY  THE  PARENT  OR  LEGAL  GUARDIAN  OF  THE  CHILD.   WHEN  RESEARCH  INVOLVES  USING  A  BLOOD  SAMPLE,  ONLY   ONE  SPOT  IS  USED  FOR  THE  RESEARCH  PROJECT.  ANOTHER   GOOD  QUALITY  BLOOD  SPOT  IS  KEPT  IN  CASE  THE  FAMILY   NEEDS  THE  SPOT,  SUCH  AS  IN  THE  CASE  OF  REQUESTING   ADDITIONAL  MEDICAL  TESTING.       Narrator:  

IF  YOU  HAVE  ANY  QUESTIONS  ABOUT  BLOOD  SPOTS,  CALL  1-­‐

-­‐Title  card  with  appropriate  phone  

512-­‐776-­‐7333  OR  TOLL  FREE  AT  1-­‐888-­‐963-­‐711  EXTENSION  

number  and  website  

7333  OR  VISIT  OUR  WEBSITE,   DSHS.STATE.TX.US/LAB/NEWBORNSCREENING.SHTM.    

  HB  411  PASSED  DURING  THE  82ND  TEXAS  LEGISLATIVE  SESSION  RELATES  TO  THE  CONFIDENTIIALITY  OF   NEWBORN  SCREENING  INFORMATION  AND  CHANGES  THE  CURRENT  OPT-­‐OUT  PROCESS  FOR  ALL   RESIDUAL  SPECIMEN  USES  TO  AN  OPT-­‐IN  PROCESS  FOR  EXTERNAL  RESEARCH  PURPOSES.  BEGINNING   JUNE  1,  2012,  PARENTS  OF  NEWBORNS  WILL  BE  PRESENTED  WITH  A  NEW  CONSENT  FORM  TO  ALLOW   THE  SPECIMENS  TO  BE  USED  FOR  PUBLIC  HEALTH  RESEARCH.  SPECIMENS  FOR  WHICH  CONSENT  HAS   NOT  BEEN  OBTAINED  WILL  BE  DESTROYED  WITHIN  2  YEARS  OF  RECEIPT  OF  THE  SPECIMEN.       THE  PROCESS  WILL  INVOLVE  CHNAGES  TO  THE  NEWBORN  SCREENING  KIT  THAT  IS  USED  FOR  THE   SUBMISSION  OF  SPECIMENS  FOR  SCREENING.  THE  NBS  STATUTE  WAS  ALSO  CHANGED  TO  BETTER   REFLECT  USES  OF  IDENTIFIED  BLOOD  SPOTS  AND  DATA  FOR  PROGRAM  QUALITY  ASSURANCE/QUALITY   CONTROL,  PROGRAM  QUALITY  IMPROVEMENT,  AND  PROGRAM  REVIEW.  IN  ADDITION,  THE   BILLLARGELY  CODIFIES  THE  POLICY  ESTABLISHED  BY  DSHS  FOR  BETTER  MANAGEMENT  REVIEW  AND   APPROVAL  NEEDED  FOR  USE  OF  RESIDUAL  DRIED  BLOOD  SPOTS  AND  DATA.  ACCESS  THE  NEWBORN   SCREENING  LABORATORY  WEB  PAGE  FOR  MORE  INFORMATION  REGARDING  DISCLOSURE  AND  THE   RETENTION  OF  BLOODSPOTS:  http://www.dshs.state.tx.us/lab/newbornscreening.shtm        

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