Current through Register Vol. 51, No. 19, September 20, 2024
A. An institution
may perform additional identification procedures on an infant before the infant
leaves the delivery room. These methods do not link mother and infant, but may
be useful in establishing the identity of an infant, and include:
(1) Cord blood sampling;
(2) Footprinting;
(3) Taking a color photograph of the
infant;
(4) Physically assessing
the infant and documenting of any distinguishing features; or
(5) Another procedure proposed by the
institution to the Secretary for approval that provides at least equivalent
identification.
B. An
institution proposing to the Secretary another procedure to identify newborn
infants shall include in the proposal at least the following information:
(1) Method of collection;
(2) Methods of storage;
(3) Specimen labeling;
(4) Specimen security and chain of
custody;
(5) Testing method, or
methods to be used;
(6)
Circumstances for testing;
(7)
Quality assurance of tests;
(8)
Confidentiality issues;
(9)
Protection against unauthorized access; and
(10) Record and documentation
system.
C.
Identification of Policies and Procedures. An institution shall:
(1) Develop policies and methods for
conducting each additional infant identification procedure under this
regulation, and each procedure shall be documented with at least the following
information:
(a) Mother's name;
(b) Mother's patient identification
number;
(c) Date of
birth;
(d) Gender of the newborn
infant;
(e) Birth order if a
multiple birth; and
(2)
Designate and train personnel responsible for performing newborn infant
identification procedures.
D. Verification.
(1) An institution shall verify that the
identification procedure was performed by completing a form supplied by the
institution or related facility. Information on the form shall include, but
need not be limited to the:
(a) Type of
identification procedures performed;
(b) Date and time the identification
procedure was performed; and
(c)
Name of personnel performing the identification procedure.
(2) An institution shall enter this form,
which lists at least the information required in §D(1)(a), (b), and (c),
of this regulation, into the infant's institutional medical record and maintain
it as part of the infant's overall institutional record.
E. Retention. An institution shall retain any
identifying material (blood sample or footprint) for at least 10 days or until
the newborn is discharged, whichever comes later.
