OAR 333-024-0390
Health Screen Testing: Personnel Qualifications and Responsibilities

(1)

Each health screen testing service shall have a director who shall meet at least one of the following qualifications:

(a)

Is a Medical Doctor (MD) or a Doctor of Osteopathy (DO) licensed to practice in Oregon and has one or more years of pertinent clinical laboratory experience;

(b)

Has an earned Doctor of Science (ScD) or Doctor of Public Health (DrPH) or Doctor of Philosophy (PhD) degree in chemistry, biochemistry, or other closely related science from an accredited institution, and has one or more years of pertinent clinical laboratory experience;

(c)

Has an earned Master of Science degree in medical technology, chemistry, biochemistry, or other closely related science from an accredited institution, and has two or more years of pertinent clinical laboratory experience;

(d)

Has a Bachelor of Science, Bachelor of Technology, or Bachelor of Arts degree in Medical Technology, Chemistry, or Biochemistry, from an accredited institution, or is a licensed pharmacist, and has four or more years of pertinent clinical laboratory experience; or

(e)

Has performed the duties of Director of a health screen testing service for at least six site days during the 12 months prior to January 1, 1990.

(2)

The Director of a health screen testing service shall be responsible for the quality of the work. This shall include, but not be limited to:

(a)

Monthly review and documentation of quality control data and instrument maintenance;

(b)

The review and documentation of all external proficiency testing, if applicable;

(c)

Review and sign procedure manuals and relevant texts initially, and also whenever there is a new procedure, change in method or policy;

(d)

Validation of new procedures prior to reporting test results;

(e)

Assurance that personnel have received the training in the tests they perform. This shall include documentation of:

(A)

Procedure Manual review;

(B)

Collection techniques;

(C)

Observation and performance of test procedures;

(D)

Calibration, quality control, and routine maintenance of equipment;

(E)

Waste disposal;

(F)

Infection control;

(G)

Emergency procedures;

(H)

Methods to maintain patient confidentiality;

(I)

Patient counseling; and

(J)

Proficiency testing.

(f)

Assurance that each person tested receives counseling and referral.

(3)

Persons wishing to qualify as Director under subsection (1)(e) of this rule must apply to the Division by December 31, 1990.

(4)

The laboratory director may direct no more than a total of five laboratories.

(5)

Moderate complexity testing requires a technical and clinical consultant as defined in OAR 333-024-0023 (Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories)(1).

(a)

A director qualifying under OAR 333-024-0022 (Qualifications and Responsibilities for Director of Moderate Complexity Laboratories)(1)(a), (b), or (c) may act as the technical consultant.

(b)

A director qualifying under OAR 333-024-0022 (Qualifications and Responsibilities for Director of Moderate Complexity Laboratories)(1)(a) may act as the clinical consultant.

(6)

Technical and clinical consultants must fulfill the responsibilities listed in OAR 333-024-0023 (Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories)(1).

(7)

All testing personnel must have at least an academic high school diploma or equivalent.

Source: Rule 333-024-0390 — Health Screen Testing: Personnel Qualifications and Responsibilities, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0390.

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 333-024-0390’s source at or​.us