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10.52.12.00.htm 10.52.12.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 52 PREVENTIVE MEDICINE Chapter 12 Newborn Screening Authority: Health-General Article, §13-109, 13-111, and 13-601―13-605, Annotated Code of Maryland
10.52.12.01.htm 10.52.12.01. 01 Purpose.. This chapter and COMAR 10.10.13 establish a coordinated Statewide system for:. A. Laboratory screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development; andB. Follow-up services to those infants with abnormal screening results..
10.52.12.02.htm 10.52.12.02. 02 Scope.. This chapter identifies standards and requirements for the Department, birthing facilities, and persons participating in one or more aspects of Maryland's Newborn Screening Program for hereditary and congenital disorders.
10.52.12.03.htm 10.52.12.03. 03 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) Birthing Facility.. a) "Birthing facility" means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants.b) "Birthing facility" includes a:. i) Birthing service that is licensed or accredited as a unit of a hospital; and. ii) Freestanding birthing center as defined in COMAR 10.05.02.01B..
10.52.12.04.htm 10.52.12.04. 04 Responsibilities of the Department.. A. Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.B. Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory o
10.52.12.05.htm 10.52.12.05. 05 Selection of Disorders for Screening.. A. The Department, with the advice of the Council, shall select the disorders for which screening is required by the Newborn Screening Program.B. The selected disorders are:. 1) Biotinidase deficiency;. 2) Congenital adrenal hyperplasia (CAH). 3) Hypothyroidism;. 4) Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT). 5) Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE).
10.52.12.06.htm 10.52.12.06. 06 Pre-Test Information.. Before a specimen is sent for newborn screening, a health care provider shall provide to the newborn infant's parent or guardian an explanation of newborn screening that includes:A. Reasons for newborn screening, including the;. 1) Purpose of the testing; and. 2) Nature and consequences of being affected by a hereditary or congenital disorder or being a carrier of a hereditary or congenital disorder; and
10.52.12.07.htm 10.52.12.07. 07 Births in a Birthing Facility.. A. Specimen Collection and Screening. If the parent or guardian of the newborn infant does not object to newborn screening, the individual in charge of a birthing facility or the individual's designated representative shall:1) Collect a blood specimen:. a) As set forth in:. i) §C and D of this regulation; and. ii) COMAR 10.10.13.13; and. b) Pursuant to the procedures established in COMAR 10.10.13.14A; and.
10.52.12.08.htm 10.52.12.08. 08 Births Outside a Birthing Facility.. A. Specimen Collection and Submission. The individual required to prepare and file the certificate of birth pursuant to Health-General Article, §4-208, Annotated Code of Maryland, shall:1) Provide to a parent or guardian the information that a health care provider is required to provide to a parent or guardian under Regulation .06 of this chapter;2) Have the parent or guardian sign a form that states the parent or guardi
10.52.12.09.htm 10.52.12.09. 09 Second Screening.. A health care provider shall have a blood specimen collected for a second screening for the disorders set forth in Regulation .05 of this chapter when the newborn is between 1 week and 4 weeks old.
10.52.12.10.htm 10.52.12.10. 10 Transport of Specimens to a Licensed Laboratory.. A. A birthing facility representative, physician, or other health care provider or, in the case when a birth occurs outside a birthing facility, the individual required to prepare and file the certificate of birth, shall send newborn screening specimens only to the Department's public health laboratory for the performance of newborn screening, as set forth in COMAR 10.10.13.14B.B. The individual responsible for collecting and s
10.52.12.11.htm 10.52.12.11. 11 Results.. A. Normal Screening Results.. 1) The Department's public health laboratory shall report normal newborn screening test results to the submitter of the specimen and to the Department's Newborn Screening Follow-Up Unit within 3 business days after receipt of the specimen.2) A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitte
10.52.12.12.htm 10.52.12.12. 12 Referral Procedures.. A. Newborn Infants Born in a Birthing Facility.. 1) The individual in charge of a birthing facility or the individual's designated representative shall develop collection and transport procedures to ensure against collecting and submitting unsatisfactory specimens for each of the categories of newborn infant listed in §A(2)4) of this regulation.2) Newborn Infants Discharged Before 24 hours of Milk Feeding. In addition to the specimen collected
10.52.12.13.htm 10.52.12.13. 13 Follow-Up Procedures.. A. Department's Responsibilities.. 1) The Department's Newborn Screening Follow-Up Unit shall investigate each abnormal result by contacting the infant's parent or guardian directly or directing the designated representative of the appropriate birthing facility, the infant's health care provider, or other appropriate individual to notify the parent or guardian regarding:a) Results of first-tier, supplemental, and second-tier tests;.
10.52.12.14.htm 10.52.12.14. 14 Counseling.. Upon request, the Department's Newborn Screening Follow-Up Unit shall make available to any parent or guardian of a newborn infant tested pursuant to this chapter, counseling services that:A. Are nondirective;. B. Emphasize informing the parent or guardian; and. C. Do not require the restriction of childbearing..
10.52.12.15.htm 10.52.12.15. 15 Records.. A. The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.B. Upon request, a laboratory or health care provider shall make available to the Department's Newborn Screening Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Department's Newborn Screening Follow-Up Unit considers necessary to:1) Screen a newborn infant for hereditary and congenital disorders set fort
10.52.12.9999.htm 10.52.12.9999. Administrative History Effective date: December 24, 1975 (2:29 Md. R. 1738). Chapter revised and recodified from COMAR 10.39.01, Testing for Hereditary Metabolic Disorders in the Newborn Child, to COMAR 10.52.12, Screening for Treatable Disorders in the Newborn Child, effective November 20, 1994 (21:23 Md. R. 1934) ―Regulations .01―12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations .01―15, Newborn Screening, adopted as an emer
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