5 Colo. Code Regs. § 1005-4-3
Current through Register Vol. 47, No. 11, June 10, 2024
Section 5 CCR 1005-4-3 - SECOND NEWBORN SCREENING REQUIREMENTS FOR NAMED SUBMITTERS3.1. Hygienic Collection Conditions Work areas used to collect second newborn screening specimens will be clean and sanitary. Individuals collecting second newborn screening specimens will follow hygienic practices including handwashing.
3.2 Notification, Specimen Collection, Handling and Submission 3.2.1 Notification The parent(s) or other legal guardian(s) of the newborn shall be advised that a second newborn screening test is required for conditions as specified in Rule 3.2.2.2 and 3.3.
3.2.1.1 Births in birthing facilities: it shall be the responsibility of the birthing facility to advise, verbally and in writing, such as by written information made available from the Department, the parent(s) or other legal guardian(s) of the newborn that it is necessary to have a second newborn screening test performed.3.2.1.2 Births outside birthing facilities: it shall be the responsibility of the physician, registered midwife, or other health professional attending a birth outside a birthing facility to advise, verbally and in writing, such as by written information made available from the Department, the parent(s) or other legal guardian(s) of the newborn that it is necessary to have a second newborn screening performed.3.2.2 Collection 3.2.2.1 The attending health care provider shall collect or require the specimen be collected from all newborns at a newborn well child appointment between 8 and 14 days after birth. The specimen shall consist of capillary blood collected by heel puncture or alternate method authorized by the Laboratory, placed directly on special blotter paper furnished by the Laboratory.
Heel puncture sampling will occur in a manner that maintains the health and safety of the newborn and individual collecting the specimen; ensure proper labeling and preparation of the specimen for delivery; and allow for accurate test results and proper diagnosis.
All circles shall be saturated with blood from one side of the blotter only. The named submitter will provide, on the attached demographic slip, all information requested by the Laboratory.
The specimens shall be air dried horizontally for three to four hours. After air-drying, specimens shall be forwarded to the Laboratory within 24 hours of collection by first class mail, courier, or overnight delivery. Specimens shall be submitted to the Laboratory in the form and manner required by the Department.
3.2.2.2 Section 25-4-1004.5(3)(b)(V), C.R.S. allows exceptions to testing of second newborn screening specimens. Second newborn screening specimen testing is not required for the conditions identified at 3.3.1, 3.3.3, 3.3.4, 3.3.5 and 3.3.6 unless: an unsatisfactory specimen was submitted for an initial newborn screening specimen; a screen positive result was obtained on an initial newborn screening specimen from the same newborn; there is no record of a satisfactory initial newborn screening specimen submission, or; for 3.3.1 only, the initial newborn screening specimen from the same newborn was collected before 24 hours of life.3.3 List of Conditions for Second Newborn Screening The Laboratory shall conduct screening tests for the following conditions:
3.3.2 Congenital Hypothyroidism3.3.6 Biotinidase Deficiency3.3.7 Congenital Adrenal Hyperplasia42 CR 02, January 25, 2019, effective 2/14/201942 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202044 CR 07, April 10, 2021, effective 5/15/2021