Section 1200-15-01-.02 - PERSONS AND/OR INSTITUTIONS RESPONSIBLE FOR TESTS FOR NEWBORN INFANTSThe following persons or institutions shall be responsible for hearing testing, critical congenital heart disease screening and blood specimen collection for metabolic/genetic disorders as designated by the Department of Health. Specimens and results shall be submitted in a manner as directed by the Department of Health; procedures are located on the Department's web page.
(1) Every chief administrative officer of a hospital and the attending physician in each instance shall:(a) Submit a satisfactory specimen of blood to the State Public Health Laboratory, Department of Health. This sample shall be collected between twenty-four and thirty-six (24-36) hours of age and mailed within twenty-four (24) hours of collection. In some cases, it may be necessary to collect a specimen prior to twenty-four (24) hours of age if the infant is going to be discharged, transferred or transfused. 1. Recollect a specimen of blood if the infant was initially screened before twenty-four (24) hours of age. This repeat sample shall be collected between twenty-four and seventy-two (24-72) hours of age and mailed within twenty-four (24) hours of collection. If the infant has been discharged, instruct every parent, guardian, or custodian to bring the infant back to the hospital or to a physician or the nearest local health department to be re-screened(b) Perform a physiologic hearing screen. The result of the hearing screen is to be reported to the Department of Health and should be done before hospital discharge or prior to one (1) month of age.(c) Perform pulse oximetry tests on all newborns to screen for critical congenital heart disease between twenty-four and thirty-six (24-36) hours of age. The recommended protocol for screening is available online at the Department of Health's web page.(2) Any health care provider(s) of delivery services in a non-hospital setting shall: (a) Submit a satisfactory specimen of blood to the State Public Health Laboratory, Department of Health, in a manner as directed by the Department. This sample shall be collected between twenty-four and thirty-six (24-36) hours of age and mailed within twenty-four (24) hours of collection. In some cases, it may be necessary to collect a specimen prior to twenty-four (24) hours of age if the infant is going to be discharged, transferred or transfused.1. Recollect a specimen of blood if the infant was initially screened before twenty-four (24) hours of age. This repeat sample shall be collected between twenty-four and seventy-two (24-72) hours of age and mailed within twenty-four (24) hours of collection. If the infant has been discharged, instruct every parent, guardian, or custodian to bring the infant back to the hospital or to a physician or the nearest local health department to be re-screened(b) Instruct the parent, guardian or custodian to obtain a physiologic hearing screen prior to one (1) month of age. A referral may be made to the State Department of Health to assist in locating a hearing provider.(c) Perform pulse oximetry tests on all newborns to screen for critical congenital heart disease between twenty-four and thirty-six (24-36) hours of age. The recommended protocol for screening is available online at the Department of Health's web page.(3) Any parent, guardian, or custodian residing in Tennessee, of an infant born in Tennessee, outside a Tennessee health care facility and without the assistance of a health care provider, shall:(a) Between twenty-four to thirty-six (24-36) hours of age present said infant to a primary care provider or local health department for blood specimen collection.(b) Obtain a physiologic hearing screen prior to one (1) month of age. A referral may be made to the State Department of Health to assist in locating a hearing provider.(c) Between twenty-four and thirty-six (24-36) hours of age present said infant to a primary care provider to perform pulse oximetry tests to screen for critical congenital heart disease. The recommended protocol for screening is available online at the Department of Health's web page.Tenn. Comp. R. & Regs. 1200-15-01-.02
Original rule certified June 7, 1974. Repeal and new rule filed September 1, 1982; effective October 1, 1982. Amendment filed September 16, 1996; effective January 28, 1997. Repeal and new rule filed December 30, 1999; effective March 14, 2000. Repeal and new rule filed September 26, 2003; effective January 28, 2004. Repeal and new rule filed December 12, 2012; effective May 31, 2013. Amendments filed July 23, 2021; effective 10/21/2021.Authority: T.C.A. §§ 4-5-202; 68-5-401, et seq.; 68-5-501, et seq.; and 68-5-901, et seq.