SPECIMEN COLLECTION AND FOLLOW-UP
§ 28.21. Responsibility for collecting and testing initial and repeat specimens.
(a) A birth center or hospital shall collect or cause to be collected from each newborn child delivered in that birth center or hospital, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2 (relating to newborn diseases listed).
(b) When a newborn child is delivered other than in a birth center or hospital, the health care practitioner who delivered the newborn child shall collect or cause to be collected from the newborn child, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2.
(c) The health care provider shall designate a newborn screening coordinator to do the following:
(1) Ensure that a specimen collection form contains correct and complete information.
(2) Ensure that the individual who collected the specimen records that act in the newborn child’s medical record.
(3) Send all specimens collected by first class mail to the testing laboratory within 24 hours of collection.
(4) Record the laboratory screening results in the newborn child’s medical records.
(5) Check each newborn child’s record prior to discharge or release to ensure that a specimen has been collected.
(6) Ensure, in the event of transfer of the newborn child prior to 48 hours of age, that the receiving health care provider has been notified that it has the responsibility to collect the initial specimen.
(7) Assist the Department in follow-up of an abnormal or presumptive abnormal test result.
(8) Follow-up inconclusive test results.
(9) Receive notification from the testing laboratory or from the Department of the need for a repeat specimen.
(d) The health care provider shall ensure that the individual responsible for specimen collection shall collect the specimen necessary to conduct tests in accordance with consensus standards developed by the National Committee for Clinical Laboratory Standards (NCCLS) and accepted by the Department. The Department will publish these standards, and any revisions thereto, in a notice in the Pennsylvania Bulletin.
Authority The provisions of this § 28.21 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).
Source The provisions of this § 28.21 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240179).
Cross References This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).
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