Chapter 01. Identification of Infants

“Born” means the complete expulsion or extraction of a product of human conception from its mother, regardless of the period of gestation, if, after the expulsion or extraction, it breathes or shows any other evidence of life, such as heartbeat, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether or not the umbilical cord is cut or the placenta is attached.

“Cord blood sampling” means the taking of a sample of a newborn infant's blood from the infant's umbilical cord.

“Footprinting” means the taking of an ink or other type of impression of the skin patterns located on the sole of the newborn infant's foot.

“Institution” means:

“Secretary” means the Secretary of Health or the Secretary's designee.

Immediately after the birth of the infant; and

Before the mother and infant are separated.

The mother's name;

The same identification number for:

The infant's gender;

The date and time of birth; and

Any other information specified by the institution's policy.

The identification band for each infant shall also include the infant's birth order indicated either alphabetically such as by A, B, C or numerically such as by 1, 2, 3; and

A band corresponding to each infant shall be attached to the mother.

Attached to the mother;

Stapled to the mother's chart; or

Disposed of in a secure disposal box.

Each time the infant is taken to the mother while at the institution; and

At the time of the discharge of the mother and infant from the institution.

Cord blood sampling;

Footprinting;

Taking a color photograph of the infant;

Physically assessing the infant and documenting of any distinguishing features; or

Another procedure proposed by the institution to the Secretary for approval that provides at least equivalent identification.

Method of collection;

Methods of storage;

Specimen labeling;

Specimen security and chain of custody;

Testing method, or methods to be used;

Circumstances for testing;

Quality assurance of tests;

Confidentiality issues;

Protection against unauthorized access; and

Record and documentation system.

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:

Designate and train personnel responsible for performing newborn infant identification procedures.

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:

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.