Sec. 10.11.01.04. Identification of Newborn Infants — Additional Procedures Permitted

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.