Date of Adoption: December 10, 2002.

     Purpose: This chapter establishes (1) State Board of Health standards for screening and diagnostic procedures for prenatal diagnosis of congenital disorders of the fetus, and (2) establishes Department of Health criteria and timelines regarding the availability and use of prenatal tests for health care providers to share with pregnant women and couples. The changes adopted by this order add time periods within which prenatal tests must be performed; updates the scope of prenatal genetics testing required for health insurance benefits packages; and adds three new tests: Maternal hepatitis B and Group B strep, and fluorescent in-situ hybridization (FISH). These rules have also been revised to eliminate obsolete text and include some editorial changes to improve the readability of the rule.

     Citation of Existing Rules Affected by this Order: Amending WAC 246-680-001, 246-680-010, and 246-680-020.

     Statutory Authority for Adoption: For WAC 246-680-001 Purpose is RCW 43.20.050, 70.54.220; for WAC 246-680-010 Definitions is RCW 48.21.244, 48.44.344, 48.46.375, 70.54.220; and for WAC 246-680-020 Board of health standards for screening and diagnostic tests during pregnancy is RCW 48.21.244, 48.44.344, 48.46.375.

      Adopted under notice filed as WSR 02-22-078 on November 5, 2002.

     Changes Other than Editing from Proposed to Adopted Version: Changes are only editorial in nature.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 3, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 3, Repealed 0.
     Effective Date of Rule: Thirty-one days after filing.

Eric Stagle

Deputy Secretary

for Mary C. Selecky

Secretary

Department of Health

Don Sloma

Executive Director

State Board of Health

OTS-5522.6

AMENDATORY SECTION(Amending Order 124B, filed 12/27/90, effective 1/31/91)

WAC 246-680-001   Purpose.   The purpose of this chapter is to((:

     (1) Establish department and state board of health description, definition,, and enumeration of prenatal tests under RCW 70.83B.020 (3)(a) and (b);

     (2))) establish standards ((of the Washington state board of health)) for screening and diagnostic procedures for prenatal diagnosis of congenital disorders of the fetus under RCW 48.21.244, 48.44.344, and 48.46.375;

     (((3) Require health care provider to provide information on certain prenatal tests under RCW 70.83B.030 to both their pregnant patients and the department;

     (4) Establish requirements for laboratories to provide information on certain prenatal tests under RCW 70.83B.030 to the department; and

     (5))) and to establish criteria and time lines ((for distribution of educational materials by health care providers related to prenatal tests)) regarding the availability and use of prenatal tests for health care providers to share with pregnant women and couples as required under RCW 70.54.220.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-001, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-001, filed 1/3/90, effective 2/3/90.]

     (2))) of this chapter, the following definitions apply:

     (1) "Department" means the Washington state department of health.

     (((3))) (2) "Health care providers" means persons licensed or certified by the state of Washington under Title 18 RCW to provide prenatal care or to practice medicine and qualified genetic counselors.

     (((4) "Laboratory" means a private or public person, agency, or organization performing prenatal tests for congenital and heritable disorders.

     (5) "Parental chromosomal)) (3) "Prenatal carrier testing" means a procedure to remove blood or other tissue from one or both parents in order to perform laboratory analysis to establish chromosome constitution or genetic carrier status of the parents.

     (((6))) (4) "Prenatal test" means any test to predict congenital or heritable disorders ((which:

     (a) When improperly utilized, may clearly harm or endanger the health, safety, or welfare of the public;

     (b) Potential harm is easily recognizable and not remote or dependent upon tenuous argument; and

     (c) As determined by the state board of health under RCW 70.83B.020(3) and enumerated by the department, includes procedures and)) that may harm or endanger the health, safety, or welfare of members of the public if improperly utilized and includes preprocedure and post-procedure genetic counseling, laboratory tests, and procedures as follows:

     (((i))) (a) Maternal serum ((alpha-fetoprotein (MSAFP))) marker screening is a procedure involving obtaining blood from a pregnant woman during the fifteenth to ((twentieth completed menstrual)) twenty-second week((s)) of gestation, in order to measure through laboratory tests the level of ((alpha-fetoprotein in the blood)) certain analytes that are associated with increased risks to the fetus or pregnancy such as alpha-fetoprotein, unconjugated estriol, human gonadotropin, inhibin, and/or PAPP-A.

     (b) Maternal hepatitis B surface antigen (HBsAg) screening is a procedure involving obtaining blood from a pregnant woman during the first trimester of pregnancy to test for maternal hepatitis B infection. HBsAg screening should be repeated during the last trimester of pregnancy if a woman is at high risk for hepatitis B infection.

     (c) Group B strep screening per vaginorectal culture at 35-37 weeks gestation is used to screen pregnant women for Group B strep colonization. The swab culture specimen must be grown in selective broth media.

     (((ii))) (d) Amniocentesis is a procedure performed after fourteen weeks of gestation to remove a small amount of amniotic fluid from the uterus of a pregnant woman, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Measure the level of alpha-fetoprotein;

     (((B))) (ii) Measure the level of acetylcholinesterase;

     (((C))) (iii) Cytogenetic studies on fetal cells including fluorescent in-situ hybridization (FISH) if indicated;

     (((D))) (iv) Biochemical studies on fetal cells or amniotic fluid; ((and

     (E))) (v) Deoxyribonucleic Acid (DNA) studies on fetal cells including fetal genotyping for isoimmunization studies; and

     (vi) Infectious disease studies.

     (((iii))) (e) Chorionic villus sampling is a procedure performed from ten to twelve weeks of gestation to remove a small amount of cells from the developing placenta, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Cytogenetic studies on fetal cells including fluorescent in-situ hybridization (FISH) if indicated;

     (((B))) (ii) Biochemical studies on fetal cells; and

     (((C))) (iii) DNA studies on fetal cells.

     (((iv))) (f) Percutaneous umbilical cord blood sampling is a procedure performed typically after fifteen weeks of gestation to obtain blood from the fetus, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Cytogenetic studies including fluorescent in-situ hybridization (FISH) if indicated;

     (((B))) (ii) Viral titer studies;

     (((C))) (iii) Fetal blood typing for isoimmunization studies;

     (((D))) (iv) Prenatal diagnostic tests for hematological disorders;

     (((E))) (v) DNA studies on fetal cells;

     (vi) Biochemical studies on fetal blood.

     (((v))) (g) Prenatal ultrasonography is a procedure performed at any time during pregnancy resulting in visualization of the uterus, the placenta, the fetus, and internal structures through use of sound waves.

     (((d) Includes pre-procedure and post-procedure genetic counseling when required under WAC 248-106-020.

     (7))) (h) "Preprocedure genetic counseling" means individual counseling, which may be part of another ((substantive)) procedure or service, involving a health care provider or a qualified genetic counselor under the direction of a physician, and a pregnant woman with or without other family members, to assess and identify increased risks for congenital abnormalities or pregnancy complications, offer specific carrier or diagnostic tests, discuss the purposes, risks, accuracy, and limitations of a prenatal testing procedure, ((and to)) aid in decision making and to assist in obtaining the desired testing or procedure.

     (((8))) (i) "Post-procedure genetic counseling" means, when test results are available, individual counseling, which may be part of another ((substantive)) procedure or service, involving a health care provider or a qualified genetic counselor under the direction of a physician and a pregnant woman with or without other family members, to discuss((:

     (a))) the ((meaning of the)) results of the prenatal tests done((; and

     (b) Subsequent)), any further testing or procedures available and/or referrals for further consultation or counseling.

     (((9))) (j) "Qualified genetic counselor" means an individual eligible for certification or certified as defined ((in Bulletin of Information, 1984,)) by the American Board of Medical Genetics, Inc., ((as a:

     (a) Genetic counselor;

     (b) Clinical geneticist;

     (c) Ph.D. medical geneticist;

     (d) Clinical cytogeneticist; or

     (e) Clinical biochemical geneticist)) or the American Board of Genetic Counseling.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-010, filed 1/3/90, effective 2/3/90.]

     (a) Maternal serum ((alpha-fetoprotein)) marker screening for all pregnant women beginning prenatal care before the twentieth completed ((menstrual)) week of gestation((:

     (i) Without the requirement for case-by-case determination; and

     (ii) Including post-procedure genetic counseling if test result is abnormal.

     (b))).

     (b) Maternal hepatitis B surface antigen (HBsAg) screening for all pregnant women during the first trimester of pregnancy and the last trimester of pregnancy if the woman is at high risk for hepatitis B infection.

     (c) Information about Group B strep should be provided to all pregnant women, including the risk to the newborn, if the woman is identified through screening as potentially colonized with Group B strep. Screening is done through prenatal vaginorectal cultures, although specific clinical indicators may preclude screening. Pregnant women who are currently colonized with Group B strep, or who have unknown Group B strep status should receive intrapartum treatment in accordance with the current standard of practice in order to reduce risk to the newborn.

     (d) Prenatal ultrasonography if one or more of the following criteria are met:

     (i) A woman undergoing amniocentesis, chorionic villus sampling, or percutaneous umbilical cord blood sampling or fetal tissue biopsy;

     (ii) ((The results on a maternal serum alpha-fetoprotein screening test are abnormal;

     (iii))) The results of a maternal serum marker screening test indicate an increased risk to the fetus or pregnancy;

     (iii) A woman or ((her partner:

     (A))) the biological father of the fetus has a ((prior child or fetus with)) personal or family history of a congenital abnormality detectable by prenatal ((ultrasonography)) ultrasound; ((or

     (B) Has a family history of congenital abnormality detectable by prenatal ultrasonography; or

     (C) Is affected with a congenital abnormality detectable by prenatal ultrasonography.

     (iv) A woman is suspected to be carrying a fetus with a congenital abnormality; or

     (v))) (iv) An increased risk of a congenital abnormality is present due to an environmental exposure including maternal exposure to alcohol; or

     (v) A medical evaluation indicates the possibility of ((hydramnios)) polyhydramnios or oligohydramnios.

     (((c))) (e) Amniocentesis ((with pre-procedure and post-procedure genetic counseling)) if one or more of the following criteria are met:

     (i) A woman is thirty-five years of age or older at the time of delivery;

     (ii) A woman or ((her partner having had)) the biologic father of the fetus has a previous child or fetus with a chromosomal abnormality or other prenatally diagnosable disorder;

     (iii) A woman or the biologic father of the fetus has a family history that includes birth defects or developmental delays;

     (iv) A woman or ((her partner)) the biologic father of the fetus is a carrier of a chromosomal rearrangement ((or anomaly));

     (((iv) A woman or her partner:

     (A) With a neural tube defect; or

     (B) Having had a child or fetus with a neural tube defect.

     (v) A woman or her partner with a history of:

     (A) A sibling with a neural tube defect;

     (B) A parent with a neural tube defect;

     (C) A niece or nephew with a neural tube defect; or

     (D) Other risk factors related to a neural tube defect.

     (vi))) (v) A woman and/or ((her partner)) the biologic father of the fetus are carriers of, or affected with, a ((prenatal)) prenatally diagnosable inherited disorder;

     (((vii))) (vi) The results ((on)) of a maternal serum ((alpha-fetoprotein)) marker screening test ((are abnormal)) indicate an increased risk to the pregnancy or fetus;

     (((viii))) (vii) A woman ((with)) has a documented history of three or more miscarriages of unknown cause when circumstances prevent parental chromosomal testing;

     (((ix))) (viii) There is an ultrasound diagnosis of fetal anomaly;

     (ix) A medical evaluation indicates an increased risk of fetal infection;

     (x) Fetal blood studies are indicated for isoimmunization studies or therapy.

     (((2) The board recommends the following additional procedures for use of insurers, health service contractors, and health maintenance organizations in determining medical necessity on a case-by-case basis:

     (a))) (f) Chorionic villus sampling with preprocedure and post-procedure genetic counseling if one or more of the following criteria are met:

     (i) A woman is thirty-five years of age or older at the time of delivery;

     (ii) A woman or ((her partner having had)) the biologic father of the fetus has a previous child or fetus with a chromosomal abnormality or other prenatally diagnosable inherited disorder;

     (iii) A woman or ((her partner)) the biologic father of the fetus is a carrier of a chromosomal rearrangement ((or anomaly));

     (iv) A woman or ((her partner are)) the biologic father of the fetus is a carrier((s)) of, or affected with, a ((prenatal)) prenatally diagnosable inherited disorder; ((or))

     (v) A woman ((with)) has a documented history of three or more miscarriages of unknown cause when circumstances prevent parental chromosomal testing((.

     (b))); or

     (vi) Fetal genotyping is indicated to determine risks for isoimmunization.

     (g) Fluorescent in-situ hybridization (FISH) if a medical evaluation indicates a rapid or specific submicroscopic chromosomal diagnosis is required to predict the prognosis for the fetus.

     (2) The board recommends the following additional procedures for use by insurers, health service contractors, and health maintenance organizations in determining medical necessity on a case-by-case basis:

     (a) Percutaneous umbilical cord blood sampling with preprocedure and post-procedure genetic counseling if one or more of the following criteria are met:

     (i) A medical evaluation indicates rapid or ((detailed)) specific submicroscopic chromosomal diagnosis or DNA diagnosis is required to((:

     (A) Protect the health of the mother; or

     (B))) predict prognosis for the fetus((.));

     (ii) A medical evaluation indicates the possibility of a ((prenatal)) prenatally diagnosable fetal infection;

     (iii) Fetal blood studies are medically indicated for isoimmunization studies or therapy;

     (iv) Fetal blood is the only means to provide biochemical genetic diagnosis;

     (v) Prenatal diagnosis of a hematological disorder((s)) is medically indicated.

     (b) Prenatal tissue biopsy if the nature of the disorder in question indicates that fetal liver, skin, or other tissue biopsy is the only means to provide biochemical genetic diagnosis to protect the health of the mother or predict the prognosis of the fetus.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-020, filed 1/3/90, effective 2/3/90.]

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