Code of Maryland Regulations (Last Updated: April 6, 2021) |
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 |
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.