The Laboratory Compliance Section enforces state regulations for clinical laboratory testing, substance of abuse testing, and health screen testing performed on human specimens. This Section also contracts with the Centers for Medicare and Medicaid Services (CMS) to carry out the Clinical Laboratory Improvement Amendments (CLIA) in Oregon.
Federal Regulation 42 CFR Part 493 (cms.hhs.gov) - Laboratory Requirements regulates:
- Clinical laboratory (pdf) tests performed on human specimens for the purpose of diagnosis and treatment or assessment of health of individuals
The Department regulates: Oregon Administrative Rule (OAR) Chapter 333, Division 024) and (Oregon Revised Statute (ORS) Chapter 438
Regulations vary depending on level of complexity. A waived license allows any staff to perform tests designated as Waived (approved waived test list) and meet only minimum requirements. A PPMP license allows the performance of waived tests plus designated practitioners to perform limited microscopic procedures PPMP Tests (pdf) (Provider Performed Microscopy Procedures) while meeting only minimum requirements. Moderate and high complexity laboratories must meet traditional clinical laboratory requirements.
Exempt from CLIA regulatory requirements are:
- Facilities collecting specimens only
- Labs performing pure research (results are scrambled and are not placed on patient's charts)
- Home testing performed by the patient or family member
Ordering lab tests and receiving results: (ORS 438.430)
All laboratory tests in Oregon require an order from a medical doctor (MD), doctor of osteopathy (DO) or other "Authorized" individual, except non-medical substance of abuse screening and health screen testing performed by a laboratory with a Health Screen Testing (HST) permit or Substance of Abuse Registration.
Further, the only tests these HST laboratories are allowed to perform without an order from an authorized individual are: blood hemoglobin, packed red cell volume (spun hematocrit), total cholesterol, blood glucose, blood in feces (stool occult blood), pregnancy test, high density lipoprotein (HDL) by direct method, triglyceride testing following a 12 to 16 hour fast, LDL may be given if it is an automatic calculation using the Friedenwald equation.
The results of these tests may be reported only to the individual ordering the tests. In the case of urine drug screens for employment, the employee may receive their results from the laboratory by following special procedures described in rule.