Sec. 10.10.13.21. Quality Assessment and Quality Assurance  


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  • A. A permittee shall:

    (1) Establish and follow a written quality assessment plan that covers all phases of the testing process;

    (2) Meet the applicable quality assurance requirements of COMAR 10.10.06; and

    (3) Have an accessioning mechanism or system that:

    (a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and

    (b) Identifies a specific analyte that requires retesting when a newborn infant's prior screening test results for that analyte are abnormal or border-line abnormal.

    B. A permittee may not test a blood-spot specimen exhibiting:

    (1) Blood that did not saturate the filter paper;

    (2) A circle containing no blood;

    (3) A blood clot or tissue on the surface of the blood;

    (4) A circle over-saturated with blood showing dark areas in the circle or at the perimeter;

    (5) Blood that appears layered or clotted; or

    (6) Serum rings or blood that appears diluted, discolored, or contaminated.

    C. A permittee may not test a blood-spot specimen:

    (1) Collected more than 10 days before the screening test is to be started;

    (2) That is unaccompanied by information necessary for the testing to be meaningful, including the:

    (a) Age of the newborn infant;

    (b) Identification of the newborn infant;

    (c) Date and time of blood-spot specimen collection;

    (d) Date and time of birth;

    (e) Newborn infant's weight; and

    (f) Date and time of a newborn infant's first feeding;

    (3) If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or

    (4) If the newborn infant was younger than 24 hours old or the newborn's age was unknown at the time of collection and the requested screening test is for:

    (a) Congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter; or

    (b) Thyroxine or thyroid stimulating hormone as specified in Regulation .12C(4) of this chapter.

    D. Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail:

    (1) That the blood-spot specimen cannot be tested; and

    (2) To submit another blood-spot specimen as soon as possible.

    E. If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall:

    (1) Give prompt notice of the erroneous or questionable patient test result to the:

    (a) Person who requested that the test be performed;

    (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; and

    (c) Follow-Up Unit;

    (2) Provide corrected reports to the persons notified in §E of this regulation;

    (3) Maintain duplicates of both the original report and the corrected report;

    (4) Conduct a quality assessment of all phases of the testing process to determine the cause of the erroneous or questionable test result;

    (5) Take the necessary remedial or corrective action to prevent recurrence of the problem; and

    (6) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:

    (a) Notifying a parent or guardian of the newborn infant of the erroneous or questionable result;

    (b) Retesting the same blood-spot specimen;

    (c) Testing a new blood-spot specimen; and

    (d) Retesting the same blood-spot specimen and testing a new blood-spot specimen.