Current through September 17, 2024
005.01
SPECIMEN COLLECTION. For all live births, the
newborn's physician must cause the collection for testing of a newborn
screening specimen for inherited and congenital infant-or childhood-on-set
diseases between 24 to 48 hours of age or immediately prior to the newborn's
discharge, whichever occurs first.
005.01(A)
PRIOR TO 24 HOURS OF AGE. If the initial specimen for
any infant is collected prior to 24 hours of age, the newborn's physician or
designee must collect or cause to be
005.01(B)
SICK, LOW BIRTH WEIGHT,
OR PREMATURE INFANTS. Newborns transferred to neonatal intensive
care units (NICU) must have a specimen collected prior to transfer, and
information communicated as required in this chapter at. The attending
physician at the hospital neonatal intensive care unit (NICU) must verify and
otherwise ensure a specimen is collected prior to the provision of any
treatment, excluding respiratory treatment. The specimen may be collected prior
to 24 hours of age. If the first specimen is collected at less than 24 hours of
age, or if the newborn was less than 2000 grams at birth, a repeat specimen
must be collected at 48-72 hours of age. A third specimen must be collected at
28 days of life or upon discharge, whichever occurs first, on all infants less
than 2000 grams at birth, or who had any prior abnormal screen
result.
005.01(C)
BLOOD
TRANSFUSION. If a newborn requires a blood transfusion, even if
prior to 24 hours of age, the specimen must be collected before the blood
transfusion.
005.01(C)(i)
SPECIMEN
COLLECTION ASSURANCE AND TIMING PRIOR TO BLOOD TRANSFUSION. The
specimen should be collected at the time blood is collected for the typing and
cross match prior to transfusion unless a dried blood spot specimen was
verified to have been collected prior to the typing and cross match. The
newborn's physician or designee must collect or cause to be collected a repeat
specimen by 48-72 hours of age if the pre-transfusion specimen was collected at
less than 24 hours of age, regardless of prior test
results.
005.01(D)
NO SPECIMEN COLLECTED. Upon notification by the
hospital that a newborn was discharged before a screening sample was collected,
the newborn's physician or designee must collect, or cause to be collected, a
screening specimen within 48 hours of parental notification.
005.01(E)
NEWBORN TRANSFER TO
ANOTHER HOSPITAL.005.01(E)(i)
BEFORE 24 HOURS OF AGE. The physician at the hospital
of birth must collect, or cause to be collected, a blood specimen immediately
prior to discharge for testing for inherited and congenital infant-or
childhood-on-set diseases if the newborn is transferred to another hospital,
either in- or out-of-state, even if this occurs before the infant is 24 hours
of age. If the specimen is collected at less than 24 hours of age, the
physician or designee at the hospital of birth must document and inform the
receiving physician that a specimen for testing for such diseases was collected
prior to 24 hours of age and notify the receiving physician that another
specimen must be collected between 48 and 72 hours of age.
005.01(E)(ii)
AFTER 24 HOURS OF
AGE. The physician at the hospital of birth must collect or cause
to be collected a blood specimen for testing for inherited and congenital
infant-or childhood-on-set diseases from any newborn being transferred to
another hospital after the newborn is 24 hours of age and notify the physician
upon transfer that a blood specimen for such diseases has been collected. The
transferring physician must immediately notify the receiving physician if the
specimen needs to be repeated, or if confirmatory testing is
required.
005.01(E)(iii)
TRANSFER FORMS. All physicians, or the physician's
designee, transferring newborns to another hospital must notify the receiving
physician in writing of the following information and fax or secure email a
copy of the written information to the Nebraska Newborn Screening Program
(NNSP) within 24 hours:
(1) Date of
transfer;
(2) Person completing
form or other written notification;
(3) Hospital of birth;
(4) Infant's name;
(5) Date and time of birth;
(6) Date and time of specimen
collection;
(7) Transferring
physician;
(8) Whether the newborn
screening specimen was or was not collected at the hospital of birth;
(9) Whether the newborn screening specimen
was or was not collected prior to 24 hours of age;
(10) Whether the newborn was transfused, and
if so, whether the specimen was collected prior to transfusion;
(11) The type and time of transfusion if the
specimen was collected post-transfusion;
(12) If the tests have not been performed and
an initial specimen needs to be collected;
(13) If the specimen was collected prior to
24 hours, or following transfusion, and a repeat specimen needs to be
collected;
(14) Receiving hospital;
and
(15) Receiving physician, if
known.
005.01(E)(iv)
USE OF TRANSFER FORMS TO NOTIFY RECEIVING PHYSICIAN.
The transfer form, approved by the Department, may be used to notify the
receiving physician, and is included as a convenience for the transferring
physician.
005.02
UNSATISFACTORY
SPECIMEN. Upon receiving notice from the testing laboratory that a
specimen is unsatisfactory, the newborn's physician or designee must collect,
or cause to be collected, a repeat specimen within 48 hours of parental
notification.
005.03
SCREENING TEST RESULTS RECEIVED. Once the physician
receives the results of the newborn screening tests, the physician or designee
must place, or cause to be placed, the results in the newborn's patient
record.
005.04
PRESUMPTIVE POSITIVE SCREENING TEST RESULT. The
newborn's physician or designee must obtain a specimen for repeat or
confirmatory testing from the newborn within 48 hours after notification by the
testing laboratory of any presumptive positive screening result including out
of range, inconclusive, or abnormal interpretations. Repeat dried blood spot
specimens must be submitted to the newborn screening laboratory that tested the
initial specimen in accordance with approved protocols for follow-up.
Confirmatory tests must be ordered, and confirmatory specimens sent in
accordance with approved protocols only to laboratories meeting standards
established by the Department.
005.05
REASONABLE
ATTEMPT. The physician or designee must make a reasonable attempt
to cause the collection of a repeat or confirmatory specimen as appropriate to
the situation whenever the initial specimen was collected at less than 24 hours
or after a transfusion; is determined to be unacceptable for testing for any
condition on the screening panel; results of any screening test are out of
range, presumptive positive, inconclusive, or abnormal; or if an infant is
found to have been discharged without the screen. A reasonable attempt means
that the physician or designee must:
(i)
Immediately notify the parent, guardian, or custodian by telephone, if
possible, and in writing;
(ii) If
there has been no response within 5 days, notify the parent, guardian, or
custodian in writing by certified mail, return receipt requested, or
equivalent; and
(iii) If there has
been no response within 10 days of first notification, notify the Nebraska
Newborn Screening Program (NNSP) in writing that obtaining the specimen was not
accomplished.
005.05(A)
ENFORCEMENT. In the event that a parent fails to
respond to notification, the physician must assure that such steps are taken as
indicated in this chapter and Neb. Rev. Stat. §
71-524.
005.06
PATIENT
EDUCATION. The physician or an individual to whom the physician
has delegated authority, must:
005.06(A)
PHYSICIAN OR PHYSICIAN DELIGATE MUST PROVIDE EDUCATION REGARDING
REQUIRED NEWBORN SCREENING. Physician or physician delegate must
provide information to the newborn's parent or legal guardian in accordance
with Neb. Rev. Stat. §
71-519(7). There
is no provision for dissent from, or refusal of, the required newborn screening
tests specified in this chapter.
