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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 37MATERNAL AND INFANT HEALTH SERVICES
SUBCHAPTER ENEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE
RULE §37.78Test Procedures and Standards

(a) A screening test for CCHD using pulse oximetry must be performed at a birthing facility that provides care to newborn patients except as described in §37.77 of this title (relating to Exemption from Screen). If another U.S. Federal Drug Administration approved instrument is available, it will be posted as identified in subsection (b) of this section.

(b) Testing procedures must be consistent with the most current published screening algorithm and any other protocol currently posted, linked, or referenced on the department's Newborn Screening website at http://www.dshs.state.tx.us/newborn/.

(c) Pulse oximeters used to conduct CCHD newborn screening must meet the standards and accuracy as determined by the Food and Drug Administration for hospital use in newborns.

(d) Newborns in the NICU must receive CCHD screening prior to discharge except as described in §37.77 of this title (relating to Exemption from Screen).


Source Note: The provisions of this §37.78 adopted to be effective August 7, 2014, 39 TexReg 5949

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