Or. Admin. Code § 333-024-0016

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0016 - Licensure Categories

(1) The four categories of clinical laboratories are:

(a) A waived laboratory which may perform only the following; dipstick or tablet reagent urinalysis (nonautomated), fecal occult blood, ovulation test-visual color comparison tests for human luteinizing hormone, urine pregnancy test-visual color comparison tests, erythrocyte sedimentation rate (nonautomated), hemoglobin-copper sulfate (nonautomated), blood glucose (by glucose monitoring devices cleared by the Food and Drug Administration specifically for home use), spun microhematocrit, and hemoglobin and glucose by Hemocue, Chemtrak Accumeter cholesterol, body fluid occult blood, nitrazine pH paper for all body fluids except blood or any other tests which are categorized as waived for CLIA laboratories, by the Health Care Financing Administration and Centers for Disease Control and Prevention:

(A) A waived laboratory is exempt from personnel requirements, proficiency testing and routine on-site inspections;

(B) A waived laboratory shall follow manufacturer's instructions for test performance:

(b) A physician performed microscopy procedure laboratory which may perform only tests in the waived category and the following: wet mounts (for presence or absence of bacteria, fungi, parasites and human cellular elements), all potassium hydroxide (KOH) preparations, pinworm examinations, fern tests, post-coital direct examinations of vaginal or cervical mucus, nasal smears for granulocytes, qualitative post-vasectomy semen analysis limited to presence or absence of sperm and motility, fecal leukocyte examinations, and urine sediment examinations, or any other tests which are categorized as provider-performed microscopy procedures for CLIA laboratories, by the Health Care Financing Administration and Centers for Disease Control and Prevention:

(A) A physician performed microscopy laboratory is exempt from routine on-site inspections;

(B) A physician performed microscopy laboratory shall follow manufacturer's instructions for test performance;

(C) A physician performed microscopy laboratory shall meet the applicable requirements for quality control, proficiency testing, quality assurance, records and reports.

(c) A moderate complexity laboratory which may perform waived, physician performed microscopy procedures, and tests identified as moderate complexity by the Health Care Financing Administration and the Centers for Disease Control and Prevention;

(d) A high complexity laboratory which may perform all categories of testing including the specialties of cytogenetics, cytology, pathology, histocompatibility and radiobioassay.

(2) Any test not listed in the waived, physician performed microscopy procedures or moderate complexity category is high complexity.

(3) The category of any test may be obtained from the Division.

Or. Admin. Code § 333-024-0016

HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.110

Stats. Implemented: ORS 438.110