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