This chapter establishes Statewide screening protocols for critical congenital heart disease in newborn infants. This chapter identifies standards and requirements for the Department, birthing facilities, nurse midwives, and persons participating in newborn screening for critical congenital heart disease. In this chapter, the following terms have the meanings indicated. Terms Defined. “Attending clinician” means an individual who is: A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland; and Responsible for the care of newborn infants, and is either: A certified nurse practitioner licensed by the Maryland Board of Nursing; or A certified nurse midwife licensed by the Maryland Board of Nursing. “Attending physician” means an individual who is: A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland; Responsible for the care of a newborn infant; Licensed to practice medicine in Maryland; and Board-certified by a member board of the American Board of Medical Specialties or an approved specialty board of the American Osteopathic Association in a specialty that includes the care of newborn infants. “Authorized health care provider” means an individual: Who has received training in the screening protocol; and For whom the CCHD screening tests are within his or her professional scope of practice. “Birth Defects Reporting and Information System” means the mandated reporting, monitoring, and follow-up of infants with birth defects as described in Health General Article, §18-206, Annotated Code of Maryland. Birthing Facility. “Birthing facility” means a facility that provides care for women during labor and delivery, and their newborn infants. “Birthing facility” includes a: Unit of a hospital that is licensed and accredited to provide birthing services; or Freestanding birthing center as defined in COMAR 10.05.02.01B. “CCHD screening” means pulse oximetry testing. “Critical congenital heart disease (CCHD)” means a congenital heart defect that places an infant at significant risk of disability or death if not diagnosed soon after birth. “Department” means the Maryland Department of Health. “Echocardiogram” means a test that uses ultrasound to provide an image of the heart. “Newborn infant” means an infant in the first 28 days of life who was born: In Maryland; or On federal property within Maryland. “Newborn Screening Follow-Up Unit” means the unit in the Department that carries out the duties set forth in Regulation .07 of this chapter. “Web-based system” means the web-based database used by the Department to collect data for newborn infant screening follow-up. Before a newborn infant is screened for CCHD, a health care provider shall provide to the newborn infant's parent or guardian an explanation of CCHD screening that includes: Reasons for screening, including: The purpose and benefits of the screening; and The nature, risks, and consequences of not screening for CCHD. A parent or guardian's right to refuse having the screening performed, including: Explaining any risk involved with the screening; and Providing a reasonable opportunity to refuse the screening. Refusal of Screening. All newborn infants shall be screened for CCHD unless the parent or guardian refuses the screening. If a parent or guardian refuses screening, a provider may not perform CCHD screening on the infant. When a parent or guardian refuses screening, the birthing facility or nurse midwife shall: Document parent refusal in the medical record; and Enter this information into the web-based system in accordance with Regulation .05 in this chapter. If the parent or guardian of the newborn infant does not refuse the screening, the birthing facility or nurse midwife shall: Perform screening on the newborn infant; and Follow-up with results in accordance with Regulation .05 of this chapter. An authorized health care provider shall perform the screening. Newborn Infants Receiving Routine Care. The birthing facility or nurse midwife shall: Perform screening on a newborn infant between 24 hours and 48 hours of life; or If unable to perform the screening, refer the infant to another authorized health care provider to perform the screening between 24 hours and 48 hours of life. If the newborn infant is discharged from a facility after 12 hours of life but before 24 hours of life, the birthing facility shall perform screening as late as is practical before the newborn infant is discharged from the birthing facility. If the newborn infant is discharged before 12 hours of life, the birthing facility shall refer the infant to another authorized health care provider to perform screening between 24 hours and 48 hours of life. Newborn Infants in Special Care or Intensive Care. Birthing facilities shall develop protocols for screening infants in the special care or intensive care nurseries. Circumstances Where Screening Is Not Indicated. There may be instances where screening for CCHD is not indicated, including but not limited to instances where: The newborn infant’s clinical evaluation to date has included an echocardiogram which ruled out CCHD; or The newborn infant has confirmed CCHD based on prenatal or postnatal testing. Recordation of Results. All screening results shall be recorded in the newborn infant’s medical record. All screening results shall be entered into the web-based system along with the following information: Newborn infant’s: Name; Date of birth; Gender; Place of birth; and Primary care physician after discharge; and Mother’s: Name; and Date of birth. Abnormal Screening Results. Abnormal screening results shall be reported by the authorized health care provider who conducted the screening to the attending physician or attending clinician immediately. A newborn infant shall be evaluated immediately by an attending physician in order to complete the recommended protocol. A newborn infant may not be discharged from care until: A cause for the abnormal screening result has been determined; or An echocardiogram has been performed, read, and determined not to indicate CCHD. The birthing facility shall enter screening results into the web-based system as specified in §A(2) of this regulation. The birthing facility shall provide notification of abnormal results to the newborn infant’s: Parent or guardian; and Primary care provider. Newborn Infants Not Screened. If a newborn infant is not screened secondary to discharge before 12 hours of life, the birthing facility or nurse midwife shall: Follow-up with the family to refer to an authorized health care provider for screening between 24 hours and 48 hours of life after: Discharge from the facility; or A home birth; and Enter into the web-based system the: Identifying information specified in §A(2) of this regulation; and Reason for not screening which shall be “early discharge”. If a newborn infant is not screened secondary to screening not being indicated, the birthing facility or nurse midwife shall enter into the web-based system: The identifying information specified in §A(2) of this regulation; The reason for not screening which shall be “screening not indicated”; and A notation of the reason for the override. If a newborn infant is not screened secondary to parent or guardian refusal, the birthing facility or nurse midwife shall enter into the web-based system the: Information specified in §A(2) of this regulation; and Reason for not screening which shall be entered as “parent refusal”. Birthing Facility Responsibilities. The birthing facility shall: Identify a clinical staff person as a contact for CCHD screening; Develop protocols to ensure that all newborn infants are offered screening; Develop protocols to ensure that all screening results are reported in accordance with Regulation .05 of this chapter; Ensure that follow-up is performed for newborn infants not screened before hospital discharge; and Develop protocols that assure the timely evaluation and referral, if necessary, of newborn infants who have abnormal screening results including: Evaluation by the attending physician; Performance of an echocardiogram; Reading of the echocardiogram; and Referral of newborn infants for further evaluation when needed. Newborn Infants Born Outside a Birthing Facility. If the birth of a newborn infant occurs outside a birthing facility, the nurse midwife shall perform screening in accordance with Regulation .05 of this chapter or refer to an authorized health care provider for screening between 24 hours and 48 hours of life. The Newborn Screening Follow-Up Unit shall: Investigate each instance of abnormal screening results to determine the cause for the abnormal result; Enter newborn infants found to have CCHD into the Birth Defects Reporting and Information System; Provide condition-specific information and resources to the family; and Perform ongoing evaluation of CCHD screening in the State. The screening of newborn infants pursuant to this chapter is a population-based public health surveillance program as defined under the Health Insurance Portability and Accountability Act of 1996. On request, a birthing facility or health care provider shall make available to the Newborn Screening Follow-Up Unit: Medical records; Records of laboratory tests; and Any other medical information the Newborn Screening Follow-Up Unit considers necessary to: Determine final outcomes of abnormal screening results; and Evaluate CCHD Screening activities in the State, including: Performance of follow-up evaluations and diagnostic tests; Initiation of treatment when necessary; and Surveillance of the accuracy and efficacy of the screening. Information that the Department receives under this chapter is confidential and may only be used or disclosed: To provide services to the newborn infant and the infant's family; To study the relationships of the various factors determining the frequency and distribution of CCHD; For State or federally mandated statistical reports; and To ensure that the information received by the Department is accurate and reliable. Health-General Article, §§13-109, 13-111, and 18-107(a), Annotated Code of Maryland Effective date: Regulations .01—.08 adopted as an emergency provision effective October 5, 2012 (39:22 Md. R. 1427); emergency status extended to June 1, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)