ORS 438.310
Inspection of laboratory premises

  • owner to submit reports and findings on communicable disease
  • information confidential

(1)

The Oregon Health Authority or its authorized representative may:

(a)

At reasonable times enter the premises of a clinical laboratory licensed or subject to being licensed under ORS 438.010 (Definitions for ORS 438.010 to 438.510) to 438.510 (Prohibited acts) to inspect the facilities, methods, procedures, materials, staff, equipment, laboratory results and records of the clinical laboratory.

(b)

Require the owner or director to submit reports on the operations and procedures of the laboratory.

(c)

Require the owner or director to submit initial laboratory findings indicative of communicable disease as defined by law or by rule. Each report shall include the name of the person from whom the specimen was obtained, if the name was reported to the laboratory, and the name and address of the physician for whom such examination or test was made. Such reports shall not be construed as constituting a diagnosis nor shall any laboratory making such report be held liable under the laws of this state for having violated a trust or confidential relationship.

(2)

The Director of the Oregon Health Authority or a designee, the authority, or any employee thereof, shall not disclose information contained in reports on communicable diseases submitted to the authority under subsection (1) of this section except as such information is made available to employees of the authority and to local health officers for purposes of administering the public health laws of this state. However, information contained in such reports may be used in compiling statistical and other data in which persons are not identified by name or otherwise.

(3)

The authority shall by rule set standards for the recognition of private laboratory accrediting organizations whose standards meet or exceed federal standards. A laboratory that is accredited by a private laboratory accrediting organization recognized by the authority under this section may submit proof of such accreditation to the authority. Upon receipt of such proof, the authority shall issue a license pursuant to ORS 438.130 (License application). [1969 c.685 §13; 1993 c.109 §9; 2001 c.104 §173; 2009 c.595 §708]

Source: Section 438.310 — Inspection of laboratory premises; owner to submit reports and findings on communicable disease; information confidential, https://www.­oregonlegislature.­gov/bills_laws/ors/ors438.­html (accessed May 26, 2025).

Current through early 2026

§ 438.310. Inspection of laboratory premises's source at oregon​.gov