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 10.10.13.24 - Reporting Abnormal Test Results to the Follow-Up Unit

Universal Citation: MD Code Reg 10.10.13.24

Current through Register Vol. 51, No. 19, September 20, 2024

A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by:

(1) Telephoning and personally speaking to an individual in the Follow-Up Unit;

(2) Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and

(3) Following up a telephonic report within 24 hours with a report by facsimile or electronic mail to the Follow-Up Unit.

B. Verification Requirement. A permittee shall contact the Follow-Up Unit by telephone at least once every 6 months to ensure that the permittee is able to meet the requirements in §A of this regulation.

C. Reporting Requirements; General. A permittee shall provide with each abnormal result, where applicable, the:

(1) Identity or name of each analyte measured;

(2) Measured numerical concentration or range of:
(a) Each analyte measured; and

(b) All related analytes measured;

(3) Value of any relevant ratios used to determine abnormality;

(4) Postnatal age of the newborn infant;

(5) Appropriate gestational age/birth weight control range;

(6) Cut-off level for the analyte of a hereditary or congenital disorder; and

(7) Measure of the degree of abnormality of the test result.

D. Reporting Requirements; Sickle Cell Disease Hemoglobin. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)-(10) of this chapter for sickle cell disease in terminology that includes:

(1) The alleles present in decreasing quantitative order; and

(2) Specifying trait states and possible disease states for at least the following alleles:
(a) Hemoglobin C;

(b) Hemoglobin D;

(c) Hemoglobin E;

(d) Hemoglobin G;

(e) Hemoglobin O; and

(f) Hemoglobin S.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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