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

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.