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PA Bulletin, Doc. No. 16-527


Newborn Screening and Follow-Up Program Critical Congenital Heart Defect Screening Results added to Blood Spot Filter Paper

[46 Pa.B. 1613]
[Saturday, March 26, 2016]

 The Newborn Child Pulse Oximetry Screening Act (11 P.S. §§ 878.1—878.5) requires newborn child pulse oximetry screening for critical congenital heart defect (CCHD). The Newborn Screening and Follow-Up Program (NSFP), established under the Newborn Child Testing Act (35 P.S. §§ 621—625), receives reports of pulse oximetry screening and blood screening of newborns. The purpose of this notice is to announce a change in the method of reporting the results of pulse oximetry screening for CCHD.

 Currently, the results of pulse oximetry screenings for CCHD are reported monthly to the NSFP electronically at's_health/14173/newborn_screening_and_follow_up_homepage/558183.

 As of January 31, 2016, the results of pulse oximetry screenings for CCHD are now able to be reported using the blood spot filter paper card previously used for reporting only the results of blood screening. Effective immediately, facilities should begin using the blood spot filter paper card to report both blood screening results and pulse oximetry screening results. If a pulse oximetry screening is completed at a different time than the required blood screenings, a Newborn Screening Status Report with the pulse oximetry screening results must be submitted to the NSFP by fax to (717) 724-6995. Training on the revised blood spot filter paper card and the reporting requirements for blood screenings and pulse oximetry screenings will be available by recorded webinar, which will be posted on the Department of Health's (Department) web site. The Newborn Screening Status Report will also be available on the Department's web site.

 During the transition from reporting monthly to reporting using the blood spot filter paper card, or until April 30, 2016, facilities should also continue monthly reporting of screening results to the NSFP per the procedures and instructions at's_health/14173/newborn_screening_and_follow_up_homepage/558183.

 Failure to comply with the reporting requirements and procedures outlined in this notice will be referred to the Department of Health, Bureau of Facility Licensure and Certification, Division of Acute and Ambulatory Care or the Department of Health, Bureau of Community Program Licensure and Certification, Division of Home Health for investigation and possible sanctions.

 For additional information or for persons with a disability who require an alternative format of this notice (for example large print, audiotape, Braille) contact Kelly Holland, Director, Division of Newborn Screening and Genetics at (717) 783-8143. Speech and/or hearing impaired persons use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service (800) 654-5984 (TT).


[Pa.B. Doc. No. 16-527. Filed for public inspection March 25, 2016, 9:00 a.m.]

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