Ill. Admin. Code tit. 77, § 661.200 - Collection and Submission of Specimens

a) All blood spot samples collected pursuant to this Part shall be submitted for testing to the laboratory designated by the Department.

b) When a retest blood spot sample is determined to be necessary pursuant to Subpart C of this Part, the Department will notify the primary care provider or designee who is responsible for obtaining another specimen and having the specimen tested.

c) For detailed and specific information regarding collection and submission of blood spot samples, refer to the current Illinois Department of Public Health Newborn Screening Practitioner's Manual. Newborn Screening shall be performed on a sample that meets the following requirements:

1) All newborns shall have a blood spot sample collected for testing as soon as possible after 24 hours of age.

2) Newborns who leave the medical care facility before they are at least 24 hours of age shall have a blood spot sample collected before discharge. The attending physician, or the attending primary care provider's designee, shall collect a second blood spot sample for testing between 48 and 72 hours of age.

3) Every newborn transferred to a second health care facility prior to 24 hours of age shall have a blood spot sample collected before transfer unless medically contraindicated. If a newborn is transferred before a blood spot sample is collected, the first facility shall inform the second facility that a blood spot sample has not been collected. The second facility shall collect and submit the blood spot sample.

4) Newborns admitted to NICU or SCBU shall have a blood spot sample collected upon admission regardless of age, medical condition or feeding. A second blood spot sample shall be collected between 48 and 72 hours of age or before discharge from the NICU or SCBU, whichever situation occurs first. For newborns less than 34 weeks gestation or who weigh less than 2,000 grams, a third blood spot sample shall be collected at 28 days of age or before discharge from the NICU or SCBU, whichever situation occurs first.

5) If a newborn requires a blood transfusion prior to 24 hours of age, a blood spot sample shall be collected before the transfusion. If the initial blood spot sample was collected post-transfusion, a second blood spot sample shall be collected 48 to 72 hours post-transfusion, and a third blood spot sample shall be collected 120 days following the last transfusion.

6) If a newborn requires total parenteral nutrition (TPN) before 24 hours of age, a blood spot sample shall be collected before the administration of TPN. If the initial blood spot sample was collected before administration of TPN, a second blood spot sample shall be collected 48 to 72 hours after the administration of TPN.

7) If a newborn requires antibiotic therapy before 24 hours of age, a blood spot sample shall be collected before the administration of the antibiotic therapy. If the initial blood spot sample was collected before administration of the antibiotic therapy, a second blood spot sample shall be collected 48 to 72 hours after administration of the antibiotic therapy.

8) For newborns not born in medical care facilities or not admitted to a medical care facility during the neonatal period (under 28 days of age), a blood spot sample shall be collected as soon as possible, but no earlier than 24 hours after birth.

d) Only collection forms with attached filter paper blood spot collection cards designated by the Department, supplied by the Division of Laboratories, Illinois Department of Public Health, shall be used in collection and submitting blood spot samples for newborn blood spot screening. The completed collection form with a blood spot sample shall be submitted for testing to the Department's designated testing laboratory.

e) Due to the nature and severity of some disorders, prompt collection and submission of blood spot samples is critical. Blood spot samples shall be submitted to the Department's designated testing laboratory within 24 hours after collection using the courier or mailing service designated by the Department.

Notes

Ill. Admin. Code tit. 77, § 661.200

Adopted at 47 Ill. Reg. 3776, effective 3/2/2023