Or. Admin. R. 333-024-0380

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-024-0380 - Permits

(1) Any person who operates a health screen testing service must obtain a permit from the Division.

(2) OAR 333-024-0370 through 333-024-0400 apply to all health screen testing services and their personnel within the State of Oregon except:

(a) Health screen testing services operated by the United States Government;

(b) Health screen testing performed in a physician's, or clinician's office for the purpose of diagnosis and treatment of their own patients;

(c) Health screen testing provided by an employer to employees if such employer contracts for the testingthrough a licensed physician, a clinical laboratory or a hospital, which is a health screen testing permittee of the Division;

(d) Screening provided by blood banks solely for assuring blood donor suitability;

(e) Health screen testing provided by local health departments; and

(f) Testing by grantee agencies for the purpose of establishing eligibility for programs administered by the Public Health Division of the Oregon Health Authority.

(3) All out-of-state laboratories performing health screen testing services in Oregon must obtain a permit and meet requirements of OAR 333-024-0370 through 333-024-0400.

(4) The Division will, upon application and payment of the required fee, issue and renew permits to the operators of health screen testing services who demonstrate to the satisfaction of the Division that:

(a) The health screen testing service is equipped to perform within the scope of its permit; and

(b) The health screen testing service meets the rules of the Division for quality assurance procedures, proficiency testing, personnel qualification and standards of counseling and referral of persons being served, as more particularly set out in OAR 333-024-0370 through 333-024-0400.

(5) The permit authorizes the operation of the health screen testing service at those health screen testing sites identified in the application and at those sites identified in compliance with OAR 333-024-0385.

(6) The health screen testing service must have a permanent location in Oregon where the Division may review records, policies and testing procedures. The permit shall be kept at the permanent location. A copy of the permit shall be displayed at each testing site.

(7) A clinical laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 Code of Federal Regulations, Part 493 -- Laboratory Requirements, must meet the requirements of 333-024-0370 through 333-024-0400 for health screen testing, and pay the fee as required in (10)(c) of this rule, in order to perform testing in Oregon without a physician's or clinician's order.

(8) All health screen testing performed outside of a licensed clinical laboratory must have a permit, with the exception of those who qualify for exemption under section (2) of this rule.

(9) Unless sooner suspended or revoked, all permit(s) issued under this section expire on June 30 of even numbered years.

(10) Requirements for permit application and renewal are as follows:

(a) Beginning on and after January 1, 2000, the application for a permit to operate a health screen testing service shall be received by the Division at least 45 days prior to initial testing;

(b) The application for a permit shall be made on forms provided by the Division and shall be executed by the operator or authorized representative of the operator of the health screen testing service. The application shall contain the name(s) of the operator, and officers if applicable, of the health screen testing service, the director, the permanent location, health screen testing sites then known and other information as the Division may require;

(c) Health screen testing services must pay a biennial, non-refundable permit fee of $150; and

(d) The health screen testing service must notify the Division of a change in owner, name or address of the permanent location within 30 days of the change.

(11) Permits may be suspended or revoked if the Division finds after hearing in accordance with ORS chapter 183 for contested cases that:

(a) The facts represented to and relied upon by the Division in issuing the permit are other than represented and relied on;

(b) The required fee has not been paid; or

(c) The operator or director of the health screen testing service has violated any provision of OAR 333-024-0375 through 333-024-0400.

(12) The health screen testing service must also be in compliance with requirements of the Clinical Laboratory Improvement Amendments of 1988, 42 Code of Federal Regulations, Part 493 -- Laboratory Requirements.

Or. Admin. R. 333-024-0380

HD 16-1990, f. & cert. ef. 6-15-90; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; OHD 5-1999, f. & cert. ef. 7-30-99; OHD 9-2000, f. & cert. ef. 11-3-00

Publications: The publication(s) referenced in this rule are available from the agency.

Stat. Auth.: ORS 438.010(10), 438.060, 438.130(2) & 438.150(5), 438.150(6), 438.150(7) & 341, 1999 OL

Stats. Implemented: ORS 438.010, 438.050, 438.055, 438.060, 438.130 & 438.150