OAR 333-520-0030: Laboratory Services

(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.