module one: introduction to the california prenatal screening program screening information system

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  • Module One: Introduction to the California Prenatal Screening ProgramScreening Information System

  • Module One: IntroductionThe goal of this module is to provide you with a quick overview of the California Prenatal Screening Program. We believe this information will help you to understand the California Prenatal Screening Program and why the pregnant woman who voluntarily participate in this Program are being seeing at State-approved Prenatal Diagnosis Centers (PDCs).

    After this overview, there will be a number of slides with Key Takeaway messages about the purpose of this Prenatal Screening Program and the Follow-up Services available to pregnant woman whose screening result is positive.

    For a complete overview about the California Prenatal Screening Program, review the Prenatal Care Provider Handbook. This resource can be found online at: http://www.cdph.ca.gov/programs/pns under Information for Providers.

  • Module One: IntroductionThe California Department of Public Health, Genetic Disease Screening Program (GDSP) administers the Prenatal Screening (PNS) Program. The purpose of this program is to provide pregnant women who participate with screening information about five birth defects:

    Down syndrome: a chromosome problem involving three copies of chromosome 21; also known as T21 or Trisomy 21

    Trisomy 18: a chromosome problem involving three copies of chromosome 18; also known as T18 or Edward syndrome

    Open Neural Tube Defect: an opening anywhere along the spinal column from the brain to the bottom, near tail bone area; also known as NTD (e.g. open spinal bifida, anencephaly)

    Open Abdominal Wall Defect: an opening in the abdomen area; also known as AWD (e.g. gastroschisis, omphalocele)

    Smith-Lemli-Opitz syndrome: an inherited genetic condition where cholesterol synthesis is affected; also known as SLOS

  • Module One: IntroductionThis Prenatal Screening Program options include :

    First Trimester Screening (between 10 weeks 0 days and 13 weeks 6 days),

    Second Trimester Screening (between15 weeks 0 days and 20 weeks 0 days)

    Combination of the First Trimester and Second blood specimens (also known as: Integrated Screening)

    What determines the type of screening a pregnant woman opts for? Depends on when she seeks prenatal care during her pregnancy Depends on what type of screening she wants after discussing her options with her prenatal care providerPrenatal Screening involves:

    A pregnant woman having her blood draw during a certain time in the pregnancy

    Information about her, the pregnancy, the blood specimen, and the amount of certain chemicals in the blood during this pregnancy

  • Prenatal Screening During 1st TrimesterBlood specimen drawn during first trimester (e.g. 10 weeks 0 days to 13 weeks 6 days)

    Nuchal translucency (NT) measurement (e.g. 11 weeks 2 days to 14 weeks 2 days) along with other NT information. NT measurement refers to measuring an area of the fetuss neck called the nuchal fold with ultrasound performed by a person with special training.

    If there is an adequate first trimester blood specimen and complete information about the pregnant woman, the pregnancy, the amount of certain chemicals in the blood and the NT, then the Prenatal Screening Program will provide a screening result in the First Trimester for Down syndrome and Trisomy 18.

    If there is only an adequate first trimester blood specimen along with complete information about the pregnant woman and the pregnancy (no complete NT information), then the pregnant woman needs a blood specimen drawn during the second trimester (15 weeks 0 days to 20 weeks 0 days) in order to receive a screening result. The Prenatal Screening Program will combine the information from the first and second trimester blood specimens to provide a screening result for Down syndrome and Trisomy 18, as well as for open neural tube defects and Smith-Lemli-Opitz syndrome. The screening for open abdominal wall defects is part of the open neural tube defect screening.Module One: Introduction

  • Prenatal Screening During 2nd TrimesterBlood specimen drawn during second trimester (15 weeks 0 days to 20 weeks 0 days)

    If there is an adequate second trimester blood specimen, it can be combine with information about the pregnant woman, the pregnancy, the amount of certain chemicals in the blood, and NT information if available, to provide a screening result for Down syndrome, Trisomy 18, open neural tube defects, and Smith-Lemli-Opitz syndrome

    If complete NT information is combine with the 2nd Trimester blood specimen information, the screening result is known as a 2nd T Quad plus NT.

    If 1st Trimester blood specimen information without NT information is combine with 2nd Trimester blood specimen information, the screening result is known as Serum Integrated Screening. If complete NT information is available with 1st and 2nd Trimester blood specimens, the screening result is known as Full Integrated Screening.Module One: Introduction

  • Prenatal Screening During 2nd Trimester (cont.)

    If there is an adequate second trimester blood specimen, it can be combine with information about the pregnant woman, the pregnancy, the amount of certain chemicals in the blood, and possibly NT information to provide a screening result for Down syndrome, Trisomy 18, open neural tube defects, and Smith-Lemli-Opitz syndrome

    If there is 2nd Trimester blood specimen information without NT information, the screening result is known as a 2nd T Quad.

    If the pregnant woman had chorionic villus sampling (CVS) in the 1st Trimester and has 2nd Trimester blood specimen information with or without complete NT information, then her screening result will only be for open neural tube defects and Smith-Lemli-Opitz syndrome. Since CVS is a test to diagnosis chromosome problems such as Down syndrome and Trisomy 18, it is not accurate or valid to screen for these conditions after a diagnostic test is done.Module One: Introduction

  • Module One: IntroductionPurpose of the PNS ProgramPurposeProgram TimelineLearning ObjectivesThe goal of this program is to:Allow First Trimester ScreeningEnable Integrated Screening (involves 1st & 2nd trimesters)

    The Integrated Screening result represents a higher detection rate for Down syndrome and Trisomy 18 and lower false positive rate than what is possible through second trimester-only screening.

    Key Takeaways

  • Module One: Introduction Integrated screening involves the pregnant woman having an adequate blood specimen drawn in the first and second trimester of her pregnancy. This information is integrated with some information about the pregnant woman, the pregnancy, amounts of certain chemicals in the blood and possibly NT information to lead to a screening result. A screening result is also known as a screening risk assessment or interpretation. An integrated screening result could either be screen positive or negative.

    If the risk assessment is screen negative, it means that the chance the fetus has one of the five birth defects screened for is low enough that further testing is not covered by the California Prenatal Screening Program

    If the risk assessment is screen positive, it means that the chance the fetus has one of the five birth defects screened for is increased enough that the California Prenatal Screening Program is able to offer further testing.

    ** Remember: although an integrated screening result allows for a higher detection rate, it is not diagnostic testing for Down syndrome, Trisomy 18, open neural tube defects or Smith-Lemli-Opitz syndrome (SLOS). Screening only identifies a pregnancy that may have an increased chance of the birth defect. Other tests are available for diagnosis.

  • Module One: Introduction This Program offers further testing to pregnant woman who have a screen positive result at State-approved Prenatal Diagnosis Centers (PDCs). This further testing is offered as a referral for follow-up services and may be accepted or declined by the pregnant woman or her prenatal care provider. Further testing details include:

    Follow-up that is free for the pregnant woman when the screening result is positive.

    Follow-up that begins with a referral by the Case Coordination Center (CCC) or by the Genetic Disease Screening Program (GDSP) through a special authorization.

    Follow-up services that are authorized depend on the trimester when the screening was done, when the referral was made to the PDC, and what trimester the pregnant patient is in when she comes to the PDC. Follow-up services that are after genetic counseling can be accepted or declined.

  • Module One: Introduction Follow-up services for 1st Trimester screen positive referrals depend on:

    when the pregnant woman schedules an appointment at a State-approved PDC what type of follow-up services she wants after genetic counseling how far along she is in this pregnancy what follow-up service(s) can be provided for this pregnancy may dependent on clinical reasons (e.g. can CVS be performed or not?) Because the decision about what type of follow-up services to accept can depend on clinical information as well as what type of information the pregnant woman wants to know about the pregnancy, the California Prenatal Screening Program has developed follow-up options to allow for this. However, this variation in follow up, especially for 1st Trimester screen positive referrals results in a complex follow-up program. This means the PDC staff including the PDC Invoice Liaision will need to know exactly what were authorized under the California Prenatal Screening Program (PNS) and exactly what service(s) the PDC provided the PNS patient.

  • Module One: Introduction Follow-up services authorized for: 1st Trimester referral: Genetic counseling: review of the screening information and results, pregnancy and family histories, as well as the risks, benefits and limitations of other testing options; if patient declines the genetic counseling, then she has declined follow-up services under this Program

    Chorionic Villus Sampling (CVS): discussion of risk, benefits, and limitations of this diagnostic procedure; can be offered up to 14 weeks 6 days; can only be offered by PDCs with State-approved CVS practitioners; if CVS provided then follow-up services for the 1st Trimester referral are complete OR Ultrasound and/or Amniocentesis: discussion of risks, benefits, and limitations of these procedures; can be offered up to 24 weeks 0 days; if CVS is not provided for 1st Trimester referral and 2nd Trimester diagnostic testing is wanted; patient can accept ultrasound and amniocentesis procedures. *Note: some prenatal women who have a 1st Trimester screen positive referral may have genetic counseling and decide not to have diagnostic testing. They decide to have a 2nd Trimester blood specimen drawn for an integrated screening result.

  • Module One: Introduction Follow-up services authorized for:

    2nd Trimester referral: Genetic counseling: review of screening information and results, pregnancy and family histories, and risks, benefits, and limitations of other testing options; if patient declines the genetic counseling, then she has declined follow-up services under this Program

    Ultrasound and/or Amniocentesis: discussion of risks, benefits, and limitations of these procedures; can be offered up to 24 weeks 0 days; patient can accept or decline either of these procedures

    Follow-up services for 2nd Trimester screen positive referrals is less complex than for 1st Trimester screen positive referrals

  • Lets see what screening results are available in the 1st Trimester and 2nd Trimester that could lead to referrals to a State-approved PDC for follow-up services.

    During First Trimester: First Trimester Combined Screen Positive for Down syndrome, or Trisomy 18, or both.

    During Second Trimester: any of these results could be screen positivefor Down syndrome, Trisomy 18, NTD or SLOS or combination of themSecond Trimester Quad Screen PositiveSecond Trimester Quad + NT Screen PositiveSerum Integrated Screen PositiveFull Integrated Screen Positive

    ** Exception: when pregnant woman had CVS in the 1st Trimester, then second trimester screen positive can only be for NTD or SLOS or bothModule One: Introduction

  • Module One: IntroductionPurpose of the PNS ProgramFollow-up for Screen Positive resultsPurposeProgram TimelineLearning ObjectivesThis program will benefit pregnant woman who have screen positive results in terms of follow-up options available at Prenatal Diagnosis Centers by:

    Allowing PDCs to offer Genetic Counseling service in the First Trimester of pregnancy to inform a pregnant woman about her first trimester screening positive risk assessment and the diagnostic services available to her. Key Takeaways

  • Module One: IntroductionPurpose of the PNS Program (Cont.)PurposeProgram TimelineLearning Objectives

    Allowing PDCs who have State- approved CVS practitioners to offer diagnostic services in the First Trimester: Chorionic Villus Sampling (CVS) CVS Karyotyping

    Allowing PDCs to offer follow-up diagnostic services in the second trimester if the patient declines CVS.

    Key Takeaways

  • Remember: A pregnant woman with a screen positive result who agrees to follow-up under this Program receives a referral in SIS from the Case Coordination Center (CCC) to the State-approved Prenatal Diagnosis Center (PDC).Depending on what period of time during the pregnancy the woman had her screening(e.g. first or second trimester) and when she agrees to follow-up service(s) will determine what type of diagnostic testing is available to her at the State-approved PDC:

    First Trimester Screening and First Trimester Follow-up (up to 14 weeks 6 days):Genetic Counseling (GC) and Chorionic Villus Sampling (CVS) with chromosome analysis

    First Trimester Screening and First Trimester Follow-up if CVS not provided and 2nd Trimester Follow-up (up to 24 weeks 0 days): Genetic Counseling (GC) and CVS not provided before 14 weeks 6 days; in 2nd Trimester: Modified Genetic Counseling (GC1) if going to same PDC where initial Genetic Counseling was provided or if going to different PDC then Genetic Counseling (GC), Ultrasound (US), and/or Amniocentesis (AM) with chromosome and alpha fetoprotein analyses

    First Trimester Screening but seen in Second Trimester for Follow-up (up to 24 weeks 0 days):Genetic Counseling (GC), Ultrasound (US), and/or Amniocentesis (AM) with chromosome and alpha fetoprotein analyses

    Second Trimester Screening and Second Trimester Follow-up (up to 24 weeks 0 days):Genetic Counseling (GC), Ultrasound (US), and/or Amniocentesis (AM) with chromosome and alpha fetoprotein analyses; this may include diagnostic testing for SLOS if screen positive for SLOS

    Second Trimester Screening but CVS in 1st Trimester and Second Trimester Follow-up (up to 24 weeks 0 days):Genetic Counseling (GC), Ultrasound (US), and/or Amniocentesis (AM) with alpha fetoprotein analysis but no chromosome analysis; this may include diagnostic testingfor SLOS if screen positive for SLOSModule One: Introduction

  • There is a Statewide Database System to manage the California Prenatal Screening Program. The computer system is called Screening Information System. The Screening Information System (SIS) allows for the information from pregnant womans test requisition form and certain chemical levels that were analyzed in her blood specimen based on how far along in pregnancy she is, and NT measurement (if applicable) to be stored.

    SIS will provide a screening result for Down syndrome, Trisomy 18 and possibly for neural tube defect and Smith-Lemli-Opitz syndrome, depending on how far along the pregnancy is. When the screening result is screen positive, SIS allows for the Case Coordination Center (CCC) to manage the referral to a Prenatal Diagnosis Center (PDC) if the patient wants follow-up based on the screen positive result. SIS allows for the PDC to scheduled the patients appointment(s) and enter the details of the patient follow-up service(s) into a Patient Services Report (PSR). The PSR can be submitted on-line to the Genetic Disease Screening Program (GDSP) for payment. SIS will utilize the complete PSRs submitted to display the services rendered by the PDC during a twice a month invoice cycle. Module One: Introduction

  • Module One: IntroductionLearning ObjectivesBy the end of this eCourse, you will:

    Become familiar with the follow-up services offered under the Prenatal Screening ProgramGain knowledge about how to find the SIS screensLearn how to use the Services Rendered Screen and other screens in SISUnderstand how the appointment status impacts Patient Service Report (PSR) and what services are authorized for payment under the Prenatal Screening Program.PurposeProgram TimelineLearning ObjectivesKey Takeaways

  • Module One: IntroductionAdditional Program Resources:

    In addition to the Provider Handbook which provides an overview of the Prenatal Screening Program. There is a PNS Program guide available to PDC Staff only:

    PDC Manual: this manual provides information on the PNS Program and provides PDC Staff with the protocols necessary to participate in the PNS Program.

    This resource can be found online at:http://www.cdph.ca.gov/programs/pns/pages/pnstraining.aspx

  • Module One: IntroductionKnowledge Check: Circle True or False

    California Prenatal Screening Program offers screening results for Down syndrome, Trisomy 18, open Neural Tube Defects which includes open abdominal wall defects, and Smith-Lemli-Opitz syndrome. True or False

    1st Trimester screening gives a screening result for Down syndrome, Trisomy 18, open Neural Tube Defects, and SLOS. True or False

    Chorionic Villus Sampling (CVS) can be offered by any of the State-approved Prenatal Diagnosis Centers (PDCs). True or False

    First Trimester screening result can only be given if there is a first trimester blood specimen between 10 weeks 0 days and 13 weeks 6 days and information about the pregnant woman and the pregnancy. True or False

  • Module One: IntroductionKnowledge Check: Circle True or False

    Combining the first trimester and second trimester blood specimens along with information about the pregnant woman, the pregnancy and possibly NT information for integrated screening provides a higher level of detection for Down syndrome and Trisomy 18 than only 2nd Trimester screening can provide. True or False

    First Trimester screen positive referrals can only have genetic counseling and chorionic villus sampling (CVS) as follow-up services. True or False

    7. Follow-up services for 2nd Trimester screening referrals by CCC are authorized up to 24 weeks 0 days. True or False

    Follow-up services for 1st Trimester screening referrals by CCC for genetic counseling and CVS are authorized up to 15 weeks 0 days. True or False

  • Module One: IntroductionKnowledge Check: Answers

    California Prenatal Screening Program offers screening results for Down syndrome, Trisomy 18, open Neural Tube Defects which includes open abdominal wall defects, and Smith-Lemli-Opitz syndrome. True; this Program offers screening information about all five of these birth defects but not every pregnant woman accepts the offer or can because of time period in the pregnancy when she gets her blood drawn2. 1st Trimester screening gives a screening result for Down syndrome, Trisomy 18, open Neural Tube Defects, and SLOS. False; 1st Trimester screening provides risk assessment for Down syndrome and Trisomy 183. Chorionic Villus Sampling (CVS) can be offered by any of the State-approved Prenatal Diagnosis Centers (PDCs). False; CVS can only be offered by PDCs that have State-approved CVS practitioners4. First Trimester screening result can only be given if there is a first trimester blood specimen between 10 weeks 0 days and 13 weeks 6 days and information about the pregnant woman and the pregnancy. False; in order for PNS Program to provide 1st Trimester risk assessment, there needs to be all the information in the question plus complete NT information.

  • Module One: IntroductionKnowledge Check: Answers

    Combining the first trimester and second trimester blood specimens along with information about the pregnant woman, the pregnancy and possibly NT information for integrated screening provides a higher level of detection for Down syndrome and Trisomy 18 than only 2nd Trimester screening can provide. True; although integrated screening provides results for open neural tube defects, open abdominal wall defects and SLOS, the higher detection is for Down syndrome and Trisomy 18First Trimester screen positive referrals can only have genetic counseling and chorionic villus sampling (CVS) as follow-up services. False; 1st Trimester referral can have genetic counseling and opt to have 2nd Trimester diagnostic services (e.g. ultrasound and/or amniocentesis) as long as a CVS was not provided in the 1st TrimesterFollow-up services for 2nd Trimester screening referrals by CCC are authorized up to 24 weeks 0 days. True; only by a special authorization via GDSP are service(s) authorized after this dateFollow-up services for 1st Trimester screening referrals by CCC for genetic counseling and CVS are authorized up to 15 weeks 0 days. False; 1st Trimester screen positive referrals by the CCC only authorize the GC and CVS service up to 14 weeks 6 days

  • Module One: CompletionModule 1 - Introduction Module 2 SIS, Referrals & PSRsModule 3 InvoicingYou have just completed Module 1. Now click on the Module 2 button to proceed through the eCourse.