Section R9-13-203. Newborn and Infant Bloodspot Tests

A.      A bloodspot test shall screen for the following congenital disorders:

1.        3-Hydroxy-3-methylglutaric aciduria,

2.        3-Methylcrotonyl-CoA carboxylase deficiency,

3.        Argininosuccinic acidemia,

4.        Beta-ketothiolase deficiency,

5.        Biotinidase deficiency,

6.        Carnitine uptake defect,

7.        Citrullinemia,

8.        Classic galactosemia,

9.        Congenital adrenal hyperplasia,

10.     Congenital hypothyroidism,

11.     Cystic fibrosis,

12.     Glutaric acidemia type I,

13.     Hemoglobin S/Beta-thalassemia,

14.     Hemoglobin S/C disease,

15.     Homocystinuria,

16.     Isovaleric acidemia,

17.     Long-chain         3-hydroxy      acyl-CoA        dehydrogenase deficiency,

18.     Maple syrup urine disease,

19.     Medium chain acyl-CoA dehydrogenase deficiency,

20.     Methylmalonic acidemia (Cbl A,B),

21.     Methylmalonic acidemia (mutase deficiency),

22.     Multiple carboxylase deficiency,

23.     Phenylketonuria,

24.     Propionic acidemia,

25.     Sickle cell anemia,

26.     Trifunctional protein deficiency,

27.     Tyrosinemia type I, and

28.     Very long-chain acyl-CoA dehydrogenase deficiency.

B.       In addition to the congenital disorders listed in subsection (A), a bloodspot test may screen for severe combined immunodeficiency when sufficient funding is available to the Department to cover the cost of the Department’s activities related to the screening for severe combined immunodeficiency.

C.      When a bloodspot test is ordered for a newborn or an infant, a health care facility's designee, a health care provider, or the health care provider's designee shall:

1.        Only   use  a  specimen  collection   kit  supplied  by  the Department;

2.        Collect a blood sample from the newborn or infant on a specimen collection kit;

3.        Complete  the  following   information  on  the  specimen collection kit:

a.         The newborn's or infant's name, gender, race, ethnicity, medical record number, and, if applicable, AHCCCS identification number;

b.        The newborn's or infant's type of food or food source;

c.         Whether the newborn or infant is from a single or multiple birth;

d.        If the newborn or infant is from a multiple birth, the birth order of the newborn or infant;

e.         Whether the newborn or infant has a medical condition that may affect the bloodspot test results;

f.         Whether the newborn or infant received a blood transfusion and, if applicable, the date of the last blood transfusion;

g.        The date and time of birth, and the newborn's or infant's weight at birth;

h.        The date and time of blood sample collection, and the newborn's  or infant's weight when  the blood sample is collected;

i.         The identification code or the name and address of the health care facility or health care provider submitting the specimen collection kit;

j.         The name, address, and telephone number or the identification code of the health care provider responsible for the management of medical services provided to the newborn or infant;

k.        Except as provided in subsection (C)(3)(1), the mother's first and last names, date of birth, name before first marriage, mailing address, telephone number, and if applicable, AHCCCS identification number; and

l.         If the newborn's or infant's mother does not have physical custody of the newborn or infant, the first and last names, mailing address, and telephone number of the person who has physical custody of the newborn or infant; and

4.        Submit the specimen collection kit to the Arizona State Laboratory no later than 24 hours or the next working day after the blood sample is collected.

D.      A health care facility or a health care provider submitting a first specimen to the Arizona State Laboratory shall pay the Department the fee in R9-13-208(A).

E.       A person who submits a second specimen to the Arizona State Laboratory shall:

1.        Pay the fee in R9-13-208(B) to the Department, or

2.        Provide the following information to the Arizona State Laboratory for billing purposes:

a.         The name, mailing address, and telephone number of the newborn's or infant's parent or the individual responsible for paying, if not the parent; and

b.        If the individual responsible for paying has health care insurance for the newborn or  infant, information about the health care insurance, including:

i.         The policyholder's name;

ii.        The name and billing address of the health care insurance company;

iii.      The member identification number;

iv.       The group number, if applicable; and

v.        The effective date of the health care insurance; or

c.         That the individual responsible for paying has no health care insurance for the newborn or infant.

F.       When a health care insurance company or an individual responsible for paying is identified as specified in subsection (E)(2), the health care insurance company or the individual responsible for paying shall pay the Department the fee in R9- 13-208(B).

G.      When a home birth not attended by a health care provider is reported to a local registrar, a deputy local registrar, or the state registrar under A.R.S. § 36-333:

1.        The local registrar, deputy local registrar, or state registrar shall notify the local health department of the county where the birth occurred; and

2.        The local health department's designee shall collect a specimen from the newborn or infant according to the requirements in R9-13-204(A)(2) or R9-13-205(C).

H.      A health care facility's designee, a health care provider, or the health care provider's designee shall ensure that:

1.        Educational materials are provided to the parent or guardian of a newborn or an infant for whom a bloodspot test is ordered, and

2.        The newborn's or infant's parent or guardian is informed of the requirement for a second specimen if the second specimen has not been collected.

I.        For a home birth, a health care provider or the health care provider's designee shall provide educational materials to the parent or guardian of a newborn or an infant for whom a bloodspot test is ordered.

Historical Note

Effective 11-74; Former Section R9-13-203 repealed, new Section R9-13-203 adopted effective July 16, 1981 (Supp. 81-4). Amended effective December 16, 1996 (Supp. 96-4). Section automatically repealed by final rulemaking at 3 A.A.R. 146, effective September 24, 1998 (Supp. 99-1). New Section recodified from R9-14- 503 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3). Section repealed; new Section made by final rulemaking at 12 A.A.R. 1166, effective April 4,

2006 (Supp. 06-2). Amended by final rulemaking at 20

A.A.R. 953, effective April 1, 2014 (Supp. 14-2). Amended by final exempt rulemaking at 21 A.A.R. 1083,

effective July 1, 2015 (Supp. 15-2).