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 (Definitions for ORS 438.010 to 438.510) through 438.510 (Prohibited acts) 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.

Source: Rule 333-520-0030 — Laboratory Services, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-520-0030.

Last Updated

Jun. 8, 2021

Rule 333-520-0030’s source at or​.us