This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
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| Rule |
Rule 3701-55-01 | Definitions.
(A) "Bureau of public health
laboratory" means the bureau which is responsible for operating the Ohio
department of health laboratory established by section 3701.22 of the Revised
Code. (B) "Certified nurse midwife"
means a registered nurse who holds a valid certificate of authority issued
under Chapter 4723. of the Revised Code that authorizes the practice of nursing
as a certified nurse midwife in accordance with section 4723.43 of the Revised
Code and rules adopted by the board of nursing. (C) "Certified nurse
practitioner" means a registered nurse who holds a valid certificate of
authority issued under Chapter 4723. of the Revised Code that authorizes the
practice of nursing as a certified nurse practitioner in accordance with
section 4723.43 of the Revised Code and rules adopted by the board of
nursing. (D) "Clinical nurse specialist"
means a registered nurse who holds a valid certificate of authority issued
under Chapter 4723. of the Revised Code that authorizes the practice of nursing
as a clinical nurse specialist in accordance with section 4723.43 of the
Revised Code and rules adopted by the board of nursing. (E) "Director" means the
director of health or his or her designee. (F) "Freestanding birthing
center" means a facility other than a hospital perinatal unit providing
obstetrical delivery services registered under section 3702.30 of the Revised
Code. (G) "Health commissioner" means
the health commissioner of a general, city or county health district or the
individual with the responsibilities of a health commissioner in a city or
county health district. (H) "Hospital" means an
institution classified and registered as a hospital under section 3701.07 of
the Revised Code that has a maternity unit or newborn nursery. (I) "Physician" means an
individual authorized under Chapter 4731. of the Revised Code to practice
medicine and surgery or osteopathic medicine and surgery. (J) "Children with medical handicaps
program" means a health care program in the Ohio department of health
established by section 3701.023 of the Revised Code. (K) "Initial specimen" means
the first satisfactory newborn screening blood sample collected on an
infant. (L) "Repeat specimen" means a
newborn screening blood sample collected subsequent to a satisfactory initial
specimen. (M) "Unsatisfactory specimen"
means a newborn screening blood sample for which testing cannot be performed or
interpreted due to errors occurring during the collection, shipping, or testing
phase.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-02 | Required screening; facility requirements.
Effective:
October 24, 2022
(A) All newborn children shall be
screened in accordance with procedures set forth in this chapter for the
presence of the following genetic, endocrine, or metabolic
disorders: (1) 2-methylbutyryl-CoA
dehydrogenase deficiency; (2) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency; (3) 3-ketothiolase
deficiency; (4) 3-methylcrotonyl-CoA
carboxylase deficiency; (5) Argininemia; (6) Argininosuccinic
acidemia; (7) Biotinidase deficiency; (8) Carnitine/acylcarnitine translocase
deficiency; (9) Carnitine palmitoyl transferase
deficiency type II; (10) Carnitine uptake defect; (11) Citrullinemia; (12) Congenital adrenal
hyperplasia; (13) Congenital
hypothyroidism; (14) Cystic fibrosis; (15) Galactosemia; (16) Glutaric acidemia type
I; (17) Glutaric acidemia type
II; (18) Glycogen storage
disease type II (Pompe); (19) Homocystinuria
(cystathionine-beta-synthase deficiency); (20) Hypermethioninemia; (21) Isovaleric acidemia; (22) Krabbe disease; (23) Long chain hydroxyacyl-CoA
dehydrogenase deficiency; (24) Maple syrup urine
disease; (25) Medium chainacyl-CoA dehydrogenase
deficiency; (26) Methylmalonic acidemia; (27) Mucopolysaccharidosis type
1; (28) Multiple CoA carboxylase
deficiency; (29) Phenylketonuria; (30) Propionic acidemia; (31) Severe combined immune
deficiency; (32) Sickle cell and other
hemoglobinopathies; (33) Spinal muscular
atrophy (SMA); (34) Trifunctional protein
deficiency; (35) Tyrosinemia type-I; (36) Tyrosinemia type-II; (37) Tyrosinemia type-III; (38) Very long chain acyl-CoA
dehydrogenase deficiency; and (39) X-linked adrenoleukodystrophy
(X-ALD). (B) All hospitals and freestanding
birthing centers that are required by this chapter to cause specimens to be
collected for newborn screening for genetic, endocrine, or metabolic disorders
shall: (1) Designate a newborn
screening coordinator and physician responsible for the coordination of the
facility's newborn screening; (2) Notify the chief of
the Ohio department of health bureau of public laboratories of the name of the
individual designated as the newborn screening coordinator on a yearly basis
and whenever the designated individual changes; and (3) Develop a written
protocol for tracking newborn screening activities. The protocol must include a
process for documenting the dates of specimen collection, shipping, and receipt
of screening results. The protocol must also include a requirement that key
fields including date and time of infant birth, date and time of specimen
collection, weight of infant, feeding status, transfusion history, and the name
of the physician attending the child after birth or a designee be placed on the
specimen demographic form sent with the specimen to the Ohio department of
health public health laboratory.
Last updated October 24, 2022 at 9:15 AM
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Rule 3701-55-03 | Public health laboratory responsibilities.
The bureau of public health laboratory will provide
screening for the presence of genetic, endocrine, or metabolic disorders in
newborn children. In providing this screening, the bureau will do all of the
following: (A) Provide instructions for collecting,
handling and transporting specimens with specimen collection kits;
(B) Complete each screening within seven
business days after receiving the properly collected and submitted
specimen; (C) Transmit the results of the screening
performed to the appropriate person, as specified in rule 3701-55-07 of the
Administrative Code, in the manner prescribed by the director; (D) Keep all newborn screening specimens
and the demographic forms associated with each specimen for not less than two
years from the date of the bureau's initial receipt of each
specimen; (E) Keep electronic raw test data and any
electronic images of reports and/or letters created for each specimen for not
less than two years from the date of the bureau's initial receipt of each
specimen; (F) Maintain electronically the screening
results, demographic information, and case management information for each
properly collected and submitted specimen received by the bureau for not less
than twenty one years; and (G) Provide reports regarding unsatisfactory specimens, disease
specific reports and other reports to programs within the department of health,
or to entities under grant or contract with the department of health, as
prescribed and deemed necessary by the director to carry out the functions and
responsibilities of the director and the department of health.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-04 | Notification prior to screening.
(A) Prior to collecting the blood
specimen for screening, the person designated in the applicable provision of
this rule will give each newborn child's parent, legal guardian, or legal
custodian, notice of the screening to be conducted by providing printed
information describing the newborn genetic, endocrine and metabolic screening
program. (1) When a birth occurs
in a hospital, the hospital will provide the information; (2) When a birth occurs
in a freestanding birthing center, the freestanding birthing center will
provide the information; (3) When a birth occurs
outside a hospital or freestanding birthing center, the attending physician,
the certified nurse midwife, the certified nurse practitioner or the clinical
nurse specialist will provide the information; (4) If there is no
physician, certified nurse midwife, certified nurse practitioner or clinical
nurse specialist in attendance at the time of birth, upon notification of the
birth, the health commissioner of the health district in which the birth
occurred will provide the information. (B) For purposes of screening for krabbe
disease, the designated person as listed in paragraph (A) of this rule will
provide information to the parent, legal guardian, or legal custodian of their
right to forgo the screening. If the parent, legal guardian, or legal custodian
communicates the decision to forgo this screening, the designated person must
document and submit this response to the bureau of public health laboratory in
a manner prescribed by the director. (C) The director will provide the printed information required by
this rule to hospitals, freestanding birthing centers, health commissioners,
physicians, certified nurse midwives, certified nurse practitioners and
clinical nurse specialists. (D) The director will conduct educational programs for hospital
and freestanding birthing center newborn screening coordinators, physicians,
certified nurse midwives, certified nurse practitioners and clinical nurse
specialists, nurses, laboratory staff and others involved in the collection and
follow-up of newborn screening specimens.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-05 | Initial specimen collection.
(A) The person responsible for causing
the initial blood specimen to be collected for screening under this rule will
be as follows: (1) For births which
occur in a hospital or freestanding birthing center, the child's attending
physician, the certified nurse midwife, the certified nurse practitioner or the
clinical nurse specialist will cause the initial blood specimen to be collected
from each newborn child prior to discharge from the newborn
nursery. (a) For a newborn child who remains in a hospital or a
freestanding birthing center for at least twenty-four hours following birth,
the blood specimen will be collected as soon as possible after twenty-four
hours of age, but no later than when the child reaches five days of
age; (b) For a newborn child who is discharged to go home from a
hospital or freestanding birthing center prior to twenty-four hours of age, the
blood specimen will be collected prior to discharge; (c) For a newborn child who is transferred to another hospital
prior to the collection of the blood specimen, the blood specimen will be
collected at the receiving hospital as soon as possible after twenty-four hours
of age, but no later than when the child reaches five days of age. (2) For births which
occur outside a hospital or freestanding birthing center, the attending
physician, the certified nurse midwife, the certified nurse practitioner or the
clinical nurse specialist will cause the blood specimen to be collected. The
physician, certified nurse midwife, certified nurse practitioner, or clinical
nurse specialist will cause the blood specimen to be collected as soon as
possible after twenty-four hours of age, but no later than when the child
reaches five days of age. (3) For births which
occur outside a hospital or freestanding birthing center when no physician,
certified nurse midwife, certified nurse practitioner or clinical nurse
specialist is in attendance, the health commissioner, will cause a blood
specimen to be collected within five business days after being notified by the
local registrar of the birth of a child under this paragraph, but no sooner
than when the child reaches twenty-four hours of age. (B) An initial blood specimen will be
collected prior to a red blood cell transfusion when possible even if the
newborn is less than twenty-four hours of age. A specimen collected from a
child who has received a transfusion of red blood cells will be so
labeled. (C) A specimen collected under this rule
will be sent to the bureau of public health laboratory for screening no later
than two business days after it is collected. (D) The person designated by this rule to
collect the initial specimen will cause a repeat specimen to be obtained within
five business days after receiving notice from the bureau of public health
laboratory that the first specimen is unsatisfactory. Unsatisfactory specimens
include, but are not limited to, specimens that are received by the bureau more
than fourteen days after they are collected. (E) If the person responsible for
collecting the repeat specimen is unable to locate the newborn child, he or she
will notify the health commissioner of the health district in which the mother,
legal guardian, or legal custodian resides. The health commissioner will make a
reasonable effort to locate the child and cause a repeat specimen to be
obtained. If the health commissioner is not able to locate the child within the
thirty days, he or she may close the file.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-06 | Required further screening if initial specimen collected at less than twenty-four hours.
(A) If the initial specimen is collected
from a child at less than twenty-four hours of age, the child's attending
physician, certified nurse midwife, certified nurse practitioner or clinical
nurse specialist and the hospital or freestanding birthing center will make a
reasonable effort to cause a repeat blood specimen to be collected from the
child in accordance with the provisions of paragraph (B) of this
rule. (B) The repeat blood specimen will be
collected after the child reaches twenty-four hours of age but no later than
when the child reaches ten days of age. (C) A specimen collected under this rule
will be sent to the bureau of public health laboratory for screening no later
than two business days after it is collected.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-07 | Required further screening or diagnostic testing if specimen abnormal.
This rule prescribes the procedures that apply if,
upon screening of a specimen, the bureau of public health laboratory determines
that the result indicates potential risk for one or more of the screened
disorders. (A) The director will communicate the
results to the following person, as applicable: (1) If a child was born
in a hospital or freestanding birthing center, the director will communicate
the results to the child's attending physician, child's primary
medical provider, pediatrician, certified nurse midwife, certified nurse
practitioner or clinical nurse specialist. If the director is unable to contact
the attending physician, child's primary medical provider, pediatrician,
certified nurse midwife, certified nurse practitioner or clinical nurse
specialist, the director will communicate the results to the newborn screening
coordinator at the facility where the child was born. (2) If the child was not
born in a hospital or freestanding birthing center, the director will
communicate the results to the person designated in paragraph (A)(2) or (A)(3)
of rule 3701-55-05 of the Administrative Code, as applicable. (B) The person notified of the results by
the director under paragraph (A) of this rule will communicate the results to
the child's parent, legal guardian, or legal custodian and will obtain and
submit a repeat blood specimen for screening or diagnostic testing in
accordance with the following procedures: (1) When the result
indicates potential risk for a disorder listed in paragraph (A) of rule
3701-55-02 of the Administrative Code, a screening or diagnostic test will be
obtained in accordance with paragraph (B)(3) of this rule as soon as possible,
but no later than ten days after notification by the director. (2) When the results are
abnormal for a hemoglobin disease or hemoglobin trait, a diagnostic test will
be obtained in accordance with paragraph (B)(3) of this rule before the child
reaches two months of age. (3) Diagnostic specimens
obtained under paragraphs (B)(1) and (B)(2) of this rule will be submitted for
testing to a laboratory certified under the current version Clinical Laboratory
Improvement Act, 42 USC 263a, that reports results with normal pediatric
reference ranges. That laboratory will promptly transmit the results of the
diagnostic test to the person who submitted the specimen. (C) If after ten business days, the
person responsible for obtaining and submitting the repeat specimen and/or
diagnostic tests under paragraph (B) of this rule is unable to obtain a
specimen from a newborn child with an initial screen result of a potential risk
despite making a reasonable effort, he or she will notify the health
commissioner of the health district in which the mother, legal guardian, or
legal custodian resides. The health commissioner will make a reasonable
effort to locate the child and cause a repeat specimen and/or diagnostic tests
to be obtained. If the health commissioner is not able to locate that child
within thirty days, he or she may close the file. (D) The health commissioner will submit a
report to the director, upon case closure, listing the names and other
identifiers of newborns the health commissioner was unable to
locate.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-08 | Procedure following repeat screening or diagnostic testing.
(A) When a repeat screen or diagnostic
test is conducted under paragraph (B) of rule 3701-55-07 of the Administrative
Code, the person who submitted the specimen will do the following: (1) Communicate the
results to the child's parent, legal, guardian or legal custodian;
(2) Communicate the
results to the director; and (3) Refer the child for
further diagnostic testing, follow-up and management in accordance with the
following, as applicable: (a) A child with abnormal results on the diagnostic test for one
or more of the disorders listed in paragraph (A) of rule 3701-55-02 of the
Administrative Code will be referred to an appropriate specialist physician who
is approved under rule 3701-43-03 of the Administrative Code as a provider for
the program for medically handicapped children and is board certified in
pediatric endocrinology, medical genetics, or immunology/infectious diseases,
or to a cystic fibrosis center approved for the program for medically
handicapped children. (b) A child with abnormal results on the screen for sickle cell
or other hemoglobin disease will be referred to a physician who is approved
under rule 3701-43-03 of the Administrative Code as a provider for the program
for medically handicapped children and is board certified in pediatric
hematology. (c) A child with abnormal results on diagnostic tests for sickle
cell and other hemoglobinopathies will be referred to a state funded Ohio
regional sickle cell project for hemoglobin counseling and
follow-up. (B) The physician to whom a child is
referred pursuant to paragraph (A) of this rule will notify the director of
results and disposition of the child within thirty days of the
referral. (C) The director may share newborn
screening information obtained pursuant to this chapter and from other sources
with programs within the department of health and with individuals or entities
under grant or contract with the department of health to assist in locating a
newborn child, the child's parent, legal guardian, or legal custodian and
to otherwise carry out the functions and responsibilities of the director and
the department of health.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-09 | Religious exception.
(A) The provisions of this chapter
requiring screening of newborn children do not apply if the parents of the
child object thereto on the grounds that such screening conflicts with their
religious tenets and practices. (B) Refusal to consent to the newborn
screening must be documented on forms provided by the Ohio department of health
or must meet the minimum warning requirements set forth on the Ohio department
of health forms. A copy of the refusal form or other documentation of parental
refusal will be sent to the Ohio department of health.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-10 | Supplemental studies.
The director may conduct supplemental studies of
the initial blood specimen collected pursuant to rule 3701-55-05 of the
Administrative Code for the purpose of determining whether additional genetic,
endocrine, or metabolic screening is necessary. The results of such
supplemental studies will assist in determining whether additional screening
can help detect other genetic, endocrine or metabolic disorders that cause
disability if undiagnosed and untreated for which a medically accepted
treatment is available. No additional blood samples or specimens will be
required to conduct a supplemental study or screening. (A) Each supplemental screening will be
completed by the bureau of public health laboratory within seven business days
after receiving the properly collected and submitted specimen. (B) If upon supplemental screening of a
specimen, the bureau of public health laboratory determines that a result
indicates a potential risk for one or more of the supplemental screenings
disorders, the director will communicate the results to the following person,
as applicable: (1) If the child was born
in a hospital or freestanding birthing center, to the child's attending
physician, certified nurse midwife, certified nurse practitioner, or clinical
nurse specialist. If the director is unable to contact the attending physician,
certified nurse midwife, certified nurse practitioner, or clinical nurse
specialist, the director will communicate the results to the newborn screening
coordinator at the facility where the child was born. (2) If the child was not
born in a hospital or freestanding birthing center, the director will
communicate the results to: (a) The attending physician, certified nurse midwife, certified
nurse practitioner or the clinical nurse specialist in attendance;
or (b) The health commissioner of the health district in which the
mother, legal guardian, or legal custodian resides, if there was no attending
physician, certified nurse midwife, certified nurse practitioner or clinical
nurse specialist in attendance. The health commissioner will make a reasonable
effort to locate the child's mother, legal guardian or legal custodian of
the child, and to notify the mother, legal guardian or legal custodian of the
child of the results of the supplemental screening.
Last updated July 17, 2023 at 2:58 PM
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Rule 3701-55-20 | Fees for genetic services, sickle cell fund.
In addition to the laboratory fee authorized by
rule 3701-49-01.1 of the Administrative Code, the director of health will
charge and collect a fee of thirty-five dollars and seventeen cents for
performing genetic, endocrine, and metabolic disorder screenings required by
section 3701.501 of the Revised Code and this chapter. The fee will be
disbursed as follows: (A) Twenty-seven dollars and twelve cents
will be deposited in the state treasury to the credit of the genetics services
fund. Sixteen dollars and eighty-five cents of each fee credited to the genetic
services fund will be used to defray the costs of programs authorized by
section 3701.502 of the Revised Code. Seven dollars and twelve cents from each
fee credited to the genetics services fund will be used to defray the costs of
phenylketonuria programs. Three dollars and fifteen cents from each fee
credited to the genetics services fund will be used to defray the cost of
programs that provide genetic counseling and education to families of newborns
with abnormal newborn screening results for cystic fibrosis. (B) Eight dollars and five cents will be
deposited into the state treasury to the credit of the sickle cell fund. Money
credited to the sickle cell fund will be used to defray costs of programs
authorized under section 3701.131 of the Revised Code.
Last updated July 17, 2023 at 2:58 PM
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