Oregon Administrative Rules
Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION
Division 520 - HOSPITAL SERVICES
Section 333-520-0030 - Laboratory Services
Universal Citation: OR Admin Rules 333-520-0030
Current through Register Vol. 63, No. 12, December 1, 2024
(1) All hospitals, regardless of classification, are required to comply with this rule.
(2) A hospital shall:
(a) Have on-site or use a licensed clinical
laboratory that meets the requirements of ORS
438.010 through
438.510 and OAR 333-024; or has
been issued a valid certificate from the federal government under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA 88), and that provides timely
laboratory services to support a hospital's medical, surgical and other
services.
(b) Have on staff or
under contract a clinical pathologist to oversee clinical laboratory testing
including pathology services.
(c)
Have appropriately trained laboratory staff on-site or on-call 24 hours a day,
7 days a week (24/7).
(3) If a hospital performs clinical laboratory testing at point of care, the requirements of subsection (2)(a) of this rule shall be met and the hospital shall:
(a) Have a written policy for point of care
testing that is reviewed by a committee, council or other reviewing body
designated by the hospital as having responsibility for laboratory
services;
(b) Designate a person
responsible for the direction and supervision of this testing;
(c) Assure that in addition to manufacturers
instructions there are procedures to cover specimen collection and
preservation;
(d) Maintain
documentation of staff specific orientation, training, and ongoing competency
for two years; and
(e) Maintain
documentation of instrument calibration, quality control records and
preventative maintenance for two years.
(4) Blood banking transfusion records shall be maintained and kept for 20 years.
Stat. Auth.: ORS 441.055
Stats. Implemented: ORS 441.055 & 442.015
Disclaimer: These regulations may not be the most recent version. Oregon may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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