10.10.13.21

.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 specimens and allows first and subsequent 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 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 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 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 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 specimen, the permittee shall notify the submitter of the unsatisfactory specimen by telephone, facsimile, or electronic mail:

(1) That the specimen cannot be tested; and

(2) To submit another 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) Newborn Screening 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;

(c) Testing a new blood-spot; and

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