Rule 111-8-10-.12 - Quality Control for Clinical Chemistry(1) The laboratory must verify (validate) that each method or testing system functions in the laboratory as specified by the manufacturer. Verification includes reportable range, accuracy, sensitivity and specificity. Verification studies must be done upon introduction of a new methodology; a laboratory may not report test results beyond or below its own established range.(2) Calibration, or calibration verification must be performed: (a) According to manufacturer specifications, or every six months, whichever is sooner;(b) When a complete change of reagents (except where all reagents are packaged together) occurs;(c) When major preventive maintenance or replacement of a critical part occurs;(d) When controls begin to reflect an unusual trend or are consistently outside acceptable ranges; or(e) At least every six months.(3) Each quantitative assay procedure shall be rechecked at least once each day of testing (24-hour period) except for blood gases, which must be rechecked each shift (see (7) below); rechecks must be conducted using two levels of calibrators, controls, standards, or a combination of these materials.(4) Limits for standards and reference samples shall be recorded and shall include the course of action to be instituted when the results are outside the acceptable limits for each lot number of controls. Manufacturer's limits may be used only if they are verified by the laboratory.(5) For urinalysis, the laboratory shall use a positive control each day of patient testing, which checks the reactivity of each constituent for which qualitative tests are reported.(6) Counting equipment used for in vitro radioassay determination shall be checked for stability at least once each day of use with radioactive standards or reference sources. Records which document the routine precision of each method, automated or manual, and its recalibration scheduled, shall be maintained. At least one standard and one reference sample (control) shall be included with each run (ad defined by guidelines) of unknown specimens.(7) For blood gas analysis, a two point calibration must be performed and documented each shift; a third point verification must be run using a separate material from that used in the two point check; for blood gas analyzers which include other chemistries (electrolytes, glucose, bun, etc.) the quality control requirements are outlined under Rule 111-8-10-.09 and .09(5).(8) For co-oximetry, preventive maintenance shall follow manufacturer's guide lines except where regulations are more stringent; a hemoglobin control shall be performed each day of testing. The calibration of the instrument shall be checked weekly unless required more frequently by the manufacturer.(9) Drug screens for medical purposes must contain a standard which contains all drugs to be identified by the method used, or for which the laboratory reports, per each plate or run. The control must go through all phases of testing including extraction, unless technology that is more current has been approved by the Department. Positive qualitative tests must be confirmed by a quantitative method, if required or recommended by the manufacturer.Ga. Comp. R. & Regs. R. 111-8-10-.12
O.C.G.A. § 31-22-1et seq.
Original Rule entitled "Quality Control for Clinical Chemistry" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.