Or. Admin. Code § 333-024-0390

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0390 - 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(1).

(A) A director qualifying under OAR 333-024-0022(1) (a, b, or c) may act as the technical consultant.

(B) A director qualifying under OAR 333-024-0022(1)(a) may act as the clinical consultant.

(6) Technical and clinical consultants must fulfill the responsibilities listed in OAR 333-024-0023(1).

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

Or. Admin. Code § 333-024-0390

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 9-2000, f. & cert. ef. 11-3-00

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

Stats. Implemented: ORS 438.150