Or. Admin. R. 333-024-1090 - Newborn Screening: Use, Release and Retention of Residual Specimens

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Residual specimens may be used by the Oregon State Public Health Laboratory for:
(a) Quality assurance and method development activities as required to maintain CLIA compliance.
(b) Program evaluation and quality improvement.
(c) Educational activities as required in ORS 433.290.
(2) The Oregon State Public Health Laboratory shall only release specimens as follows:
(a) To a third-party laboratory to perform some or all testing described in OAR 333-024-1070.
(b) If required by a court order.
(c) To the parent or legal guardian of the infant, or a third party identified by a parent or legal guardian, with a parent or legal guardian's written authorization, according to the Oregon State Public Health Laboratory procedure for requesting specimens.
(3) Specimens may not be released under subsection (2)(c) of this rule within 30 days of the report of the screening results.
(4) Specimens submitted to the Oregon State Public Health Laboratory are retained for 18 months after which the specimen is destroyed using a secure method, except as necessary to comply with section (1) of this rule. The destruction may occur at any time in the month following the specimen's 18-month retention limit.
(5) Specimens retained for longer than 18 months as necessary to comply with section (1) of this rule shall be de-identified by the Oregon State Public Health Laboratory.

Notes

Or. Admin. R. 333-024-1090
PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019; PH 24-2019, amend filed 11/18/2019, effective 11/25/2019

Statutory/Other Authority: ORS 413.014, 433.285 & 431A.750

Statutes/Other Implemented: ORS 433.285, 433.290 & 433.295

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