2019 Oregon Revised Statutes
Volume : 12 - Public Health
Chapter 438 - Laboratories; Anatomical Material
Section 438.720 - Rules; inspection of organization premises and records.
(1) The Oregon Health Authority may:
(a) Adopt rules to implement ORS 438.705 to 438.720 and 438.994;
(b) Inspect the premises and records of a nontransplant anatomical research recovery organization as is reasonably necessary to determine compliance with ORS 438.710 and 438.715; and
(c) In lieu of conducting inspections authorized under paragraph (b) of this subsection, accept accreditation from an accrediting body approved by the authority.
(2) To be approved under subsection (1)(c) of this section, an accrediting body must:
(a) Require a nontransplant anatomical research recovery organization to document processes related to the recovery, handling and distribution of anatomical material and submit to the accrediting body that documentation.
(b) Require a nontransplant anatomical research recovery organization to keep and maintain all records related to the recovery or distribution of anatomical material for at least 10 years.
(c) Conduct, or have a designee conduct, regular on-site compliance inspections of a nontransplant anatomical research recovery organization’s records, processes and materials relating to:
(A) Donor intake;
(B) Acquisition, preparation, labeling, packaging, storage and distribution of anatomical material; and
(C) Any inspection of a facility owned or operated by the nontransplant anatomical research recovery organization. [2013 c.356 §4]
