Or. Admin. R. 333-024-0265 - Procedure

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Prior to performing patient screening, the laboratory shall have available documentation of its expertise with the assays of MSAFP, AFAFP, Serum Human Chorionic Gonadotropin, Unconjugated Estriol, Amniotic Fluid Acetylcholinesterase or other related markers for the purposes of congenital/genetic screening.
(2) Each laboratory shall establish reference data based on the laboratory's own test results for normal MSAFP, AFAFP, Serum Human Chorionic Gonadotropin, Unconjugated Estriol, Amniotic Fluid Acetylcholinesterase or other related markers for medically applicable times throughout the pregnancy.
(3) When required for calculation or interpretation of results, protocols shall be developed and implemented for adjusting test values for variables such as: gestational age, maternal weight, diabetic status, race or other factors.
(4) At least annually, the laboratory shall:
(a) Review the most recent patient test results;
(b) Compare current patient test data to previous results to ascertain changes in the median and dispersion of values;
(c) Investigate the causes of variation;
(d) Make corrections as needed; and
(e) Calculate and review percentages of abnormal results.
(5) Laboratories shall obtain and use in the calculation and interpretation, where applicable, at least the following information on each patient:
(a) Date of birth;
(b) An accurate estimation of gestational age, and method used for this determination;
(c) Patient's weight at the time the sample was obtained;
(d) Whether the patient is an insulin-dependent diabetic (IDDM);
(e) Patient's racial extraction;
(f) Date sample was collected;
(g) Patient history of multiple gestations; and
(h) Other pertinent medical information.
(6) The multiples of the median (MOM) shall be calculated using the laboratory's own reference data for each medically applicable time during gestation.
(7) Patient reports shall include information as indicated in section (5) of this rule. Additional information shall include:
(a) Defects screened for;
(b) Risk or cutoff used for determination of abnormal results;
(c) Interpretation of results; and
(d) Any other medically relevant information necessary for the interpretation of results.
(8) Policies shall be established for timely reporting of all results to the individual authorized to receive the patient's results.

Notes

Or. Admin. R. 333-024-0265
HD 28-1988, f. & cert. ef. 12-7-88; HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.320

Stats. Implemented: ORS 438.320

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