OAR 333-024-0380
Health Screen Testing: Permits

(1)

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

(2)

OAR 333-024-0370 (Health Screen Testing: Purpose) through 333-024-0400 (Health Screen Testing: Quality Assurance) 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 Oregon Health Authority, Public Health Division.

(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 (Health Screen Testing: Purpose) through 333-024-0400 (Health Screen Testing: Quality Assurance).

(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 (Health Screen Testing: Purpose) through 333-024-0400 (Health Screen Testing: Quality Assurance).

(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 (Health Screen Testing: Testing Site Schedule).

(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 (Health Screen Testing: Purpose) through 333-024-0400 (Health Screen Testing: Quality Assurance) 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 (Administrative Procedures Act) 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 (Health Screen Testing: Definitions) through 333-024-0400 (Health Screen Testing: Quality Assurance).

(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.
[Publications: Publications referenced are available from the agency.]

Source: Rule 333-024-0380 — Health Screen Testing: Permits, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0380.

333‑024‑0005
Purpose 333‑024‑0010
Definitions 333‑024‑0012
Licensure 333‑024‑0016
Licensure Categories 333‑024‑0020
Licensure for Performance of Laboratory Specialties 333‑024‑0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333‑024‑0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333‑024‑0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333‑024‑0026
Equipment and Facilities 333‑024‑0035
Internal Quality Control for Moderate and High Complexity Laboratories 333‑024‑0037
Specialty and Subspecialty Quality Control 333‑024‑0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333‑024‑0043
Quality Assurance 333‑024‑0045
Venereal Disease Testing 333‑024‑0050
Records and Reports 333‑024‑0053
Accreditation Organizations and Accredited Laboratories 333‑024‑0055
Incompetence 333‑024‑0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333‑024‑0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333‑024‑0305
Testing for Substances of Abuse: Purpose and Scope 333‑024‑0310
Testing for Substances of Abuse: Definitions 333‑024‑0315
Testing for Substances of Abuse: Licensure 333‑024‑0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333‑024‑0325
Testing for Substances of Abuse: Incompetence 333‑024‑0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333‑024‑0335
Testing for Substances of Abuse: Internal Quality Assurance 333‑024‑0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333‑024‑0345
Testing for Substances of Abuse: Confirmatory Testing 333‑024‑0350
Testing for Substances of Abuse: Equipment and Facilities 333‑024‑0360
Testing for Substances of Abuse: Special Category Laboratories 333‑024‑0365
Testing for Substances of Abuse: Substance of Abuse Registration 333‑024‑0370
Health Screen Testing: Purpose 333‑024‑0375
Health Screen Testing: Definitions 333‑024‑0380
Health Screen Testing: Permits 333‑024‑0385
Health Screen Testing: Testing Site Schedule 333‑024‑0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333‑024‑0395
Health Screen Testing: Tests Performed 333‑024‑0400
Health Screen Testing: Quality Assurance 333‑024‑1000
Newborn Screening: Purpose 333‑024‑1010
Newborn Screening: Definitions 333‑024‑1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333‑024‑1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333‑024‑1030
Newborn Screening: Timing for Collecting Specimens 333‑024‑1040
Newborn Screening: Manner of Submitting Specimens 333‑024‑1050
Newborn Screening: Religious Exemption from Newborn Testing 333‑024‑1060
Newborn Screening: Improperly Collected Specimens 333‑024‑1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333‑024‑1080
Newborn Screening: Result Reporting and Follow-up 333‑024‑1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333‑024‑1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333‑024‑1110
Newborn Screening: Failure to Comply 333‑024‑2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0380’s source at or​.us