OAR 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.

Source: Rule 333-024-0016 — Licensure Categories, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0016.

333–024–0005
Purpose
333–024–0010
Definitions
333–024–0012
Licensure
333–024–0016
Licensure Categories
333–024–0020
Licensure for Performance of Laboratory Specialties
333–024–0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories
333–024–0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories
333–024–0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories
333–024–0026
Equipment and Facilities
333–024–0035
Internal Quality Control for Moderate and High Complexity Laboratories
333–024–0037
Specialty and Subspecialty Quality Control
333–024–0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections)
333–024–0043
Quality Assurance
333–024–0045
Venereal Disease Testing
333–024–0050
Records and Reports
333–024–0053
Accreditation Organizations and Accredited Laboratories
333–024–0055
Incompetence
333–024–0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose
333–024–0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure
333–024–0305
Testing for Substances of Abuse: Purpose and Scope
333–024–0310
Testing for Substances of Abuse: Definitions
333–024–0315
Testing for Substances of Abuse: Licensure
333–024–0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors
333–024–0325
Testing for Substances of Abuse: Incompetence
333–024–0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports
333–024–0335
Testing for Substances of Abuse: Internal Quality Assurance
333–024–0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections)
333–024–0345
Testing for Substances of Abuse: Confirmatory Testing
333–024–0350
Testing for Substances of Abuse: Equipment and Facilities
333–024–0360
Testing for Substances of Abuse: Special Category Laboratories
333–024–0365
Testing for Substances of Abuse: Substance of Abuse Registration
333–024–0370
Health Screen Testing: Purpose
333–024–0375
Health Screen Testing: Definitions
333–024–0380
Health Screen Testing: Permits
333–024–0385
Health Screen Testing: Testing Site Schedule
333–024–0390
Health Screen Testing: Personnel Qualifications and Responsibilities
333–024–0395
Health Screen Testing: Tests Performed
333–024–0400
Health Screen Testing: Quality Assurance
333–024–1000
Newborn Screening: Purpose
333–024–1010
Newborn Screening: Definitions
333–024–1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted
333–024–1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted
333–024–1030
Newborn Screening: Timing for Collecting Specimens
333–024–1040
Newborn Screening: Manner of Submitting Specimens
333–024–1050
Newborn Screening: Religious Exemption from Newborn Testing
333–024–1060
Newborn Screening: Improperly Collected Specimens
333–024–1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing
333–024–1080
Newborn Screening: Result Reporting and Follow-up
333–024–1090
Newborn Screening: Use, Release and Retention of Residual Specimens
333–024–1100
Newborn Screening: Ordering Specimen Collection Kits and Fees
333–024–1110
Newborn Screening: Failure to Comply
333–024–2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0016’s source at or​.us