Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
Section 10.10.13.23 - Reporting Test Results
Universal Citation: MD Code Reg 10.10.13.23
Current through Register Vol. 51, No. 19, September 20, 2024
A. All Test Results. For a newborn infant, a permittee shall:
(1) Report all first-tier, supplemental, and
second-tier results to:
(a) The person who
requested the test; and
(b) An
individual who will use the test results in identifying, tracking, caring for,
and treating the newborn infant, including:
(i) A physician specialist; and
(ii) Personnel in the Follow-Up
Unit;
(2)
Report to the persons listed in §A(1) of this regulation within 3 working
days after the laboratory obtains the blood-spot specimen, all test results
that are within normal limits;
(3)
Report to a person requesting a second or subsequent screening the test results
from the newborn infant's prior screening if not previously reported to the
person;
(4) Include with each
report the following information:
(a) Date the
blood-spot specimen was received in the laboratory;
(b) Date of the report; and
(c) Cut-off level for each reported analyte;
and
(5) Report all
abnormal test results to the Follow-Up Unit on the same day that a test result
is obtained and reviewed.
B. Specific Test results. A permittee may not report a test result as being within normal limits for:
(1) Amino acid levels for disorders specified
in Regulation .12C(11)-(24) of this chapter and for a total galactose level for
galactosemia as specified in Regulation .12C(3) of this chapter if:
(a) A newborn infant was not on milk or
formula feeding at least 24 hours before the blood-spot specimen was collected;
or
(b) The time of milk or formula
feeding is unknown; or
(2) 17-hydroxy progesterone results for
congenital adrenal hyperplasia as specified in Regulation .12C(2) of this
chapter and thyroxine and thyroid stimulating hormone for hypothyroidism as
specified in Regulation .12C(4) of this chapter if the blood-spot specimen was
collected when the newborn infant was:
(a)
Younger than 24 hours old; or
(b)
Of unknown age.
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