1. (1) All hospitals, regardless of classification, are required to comply with this rule.

2. (2) A hospital shall:

   1. (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.
   2. (b) Have on staff or under contract a clinical pathologist to oversee clinical laboratory testing including pathology services.
   3. (c) Have appropriately trained laboratory staff on-site or on-call 24 hours a day, 7 days a week (24/7).

3. (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:

   1. (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;
   2. (b) Designate a person responsible for the direction and supervision of this testing;
   3. (c) Assure that in addition to manufacturers instructions there are procedures to cover specimen collection and preservation;
   4. (d) Maintain documentation of staff specific orientation, training, and ongoing competency for two years; and
   5. (e) Maintain documentation of instrument calibration, quality control records and preventative maintenance for two years.
4. (4) Blood banking transfusion records shall be maintained and kept for 20 years.

Statutory/Other Authority

ORS 441.055

Statutes/Other Implemented

ORS 441.055 & 442.015

History

PH 11-2009, f. & cert. ef. 10-1-09
HD 21-1993, f. & cert. ef. 10-28-93
HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-072-0005(8)
HD 11-1980, f. & cert. ef. 9-10-80, Renumbered from 333-023-0126
HD 7-1979, f. & cert. ef. 7-17-79
HD 72, f. 11-7-74, cert. ef. 12-11-74
HD 25, f. 10-20-72, cert. ef. 11-1-72
HB 252, f. 7-22-70, cert. ef. 8-25-70
HB 209, f. & cert. ef. 12-18-68
HB 183, f. & cert. ef. 5-26-66