.21 Quality Assessment and Quality Assurance.

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.