Or. Admin. R. 333-024-0022

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

Section 333-024-0022 - Qualifications and Responsibilities for Director of Moderate Complexity Laboratories

(1) The director shall meet at least one of the qualifications in 333-024-0021 or one of the following:

(a) Is a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine; and

(A) Has one or more years of directing or supervising non-waived laboratory testing; or

(B) Has at least 20 continuing medical education credit hours in laboratory practice; or

(C) Has 1 year of laboratory training in non-waived testing during a residency.

(b) Has earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and

(A) Has at least one year of pertinent laboratory training or experience; and

(B) Has at least one year of supervisory laboratory experience in non-waived testing.

(c) Has earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and

(A) Has at least 2 years of laboratory training or experience, or both in non-waived testing; and

(B) Has at least 2 years of supervisory laboratory experience in non-waived testing.

(2) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of competent personnel, equipment, safety, quality assurance, all testing including proficiency testing, and test reports:

(a) The laboratory director may, if qualified, perform the duties of the technical consultant, clinical consultant, and testing personnel or delegate these responsibilities in writing to other qualified individuals; and must ensure that all duties are properly performed, and must be accessible to provide on site, telephone or electronic consultation;

(b) The laboratory director may direct no more than five laboratories;

(c) The director must ensure:

(A) Quality services for aspects of test performance;

(B) Environmental conditions provide a safe testing site;

(C) Test methodologies provide accurate results;

(D) Verification procedures are used to determine the accuracy, precision, and other pertinent performance characteristics of the method;

(E) Laboratory personnel perform only director approved methods;

(F) The laboratory is enrolled in an approved proficiency testing program if required;

(G) The proficiency test samples shall be tested in the same manner as patient specimens, results returned within established time frames, reviewed by the director or designate, and corrective action taken, if necessary;

(H) Quality control and quality assurance programs are established and maintained;

(I) Acceptable levels of analytical performance for each test are established and maintained;

(J) That all necessary remedial actions are taken and documented whenever necessary and patient test results are reported only when the system is functioning properly;

(K) That test results include pertinent information required for interpretation;

(L) That consultation is available to the laboratory's clients, if applicable;

(M) The employment of a sufficient number of qualified personnel to provide consultation, supervision and accurate test performance and report test results in accordance with their personnel responsibilities;

(N) That policies and procedures are established to monitor the competency of the individuals performing the testing and provide remedial training, or education as needed;

(O) That an approved procedure manual is available to all testing personnel;

(P) The duties and responsibilities of each consultant and each testing personnel are specified in writing; and

(Q) All personnel have appropriate training.

Or. Admin. R. 333-024-0022

HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.210 & 438.330

Stats. Implemented: ORS 438.210 & 438.220