Or. Admin. Code § 333-024-0021

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

Section 333-024-0021 - Qualifications and Responsibilities of Directors for High Complexity Laboratories

(1) The Director shall meet at least one of the qualifications defined by the following:

(a) Is a pathologist certified in clinical or anatomical pathology by the American Board of Pathology, the American Osteopathic Board of Pathology, or is eligible for such certification (Board eligible);

(b) Is certified or board eligible by the American Board of Oral Pathology. An oral pathologist shall only direct an oral pathology laboratory;

(c) Is a physician who:

(A) Is eligible for certification by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Society of Cytology, the American Board of Dermatology, or other national accrediting board related to a laboratory specialty as may be approved by the Division; and

(B) Has had two or more years of general laboratory training and experience.

(d) Has an earned degree of Doctor of Science, Doctor of Public Health, or Doctor of Philosophy or an acceptable degree, as determined by the Division, from an accredited college or university with a major in the chemical, physical, or biological sciences and possesses special qualifications as follows: is certified or is eligible for certification by the American Board of Medical Microbiology, American Board of Bioanalysis, the American Board of Clinical Chemistry, or other national accrediting board related to a laboratory specialty or possesses other special qualifications as approved by the Division; and has one or more years experience supervising high complexity testing;

(e) Was responsible for the direction of a clinical laboratory for at least 12 months within the five years preceding January 1, 1970, and has had at least two years of pertinent clinical laboratory experience as determined by the Division;

(f) Was serving as a laboratory director in Oregon and either previously qualified or could have qualified as a laboratory director in Oregon on or before February 28, 1992, and is a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine, and has two or more years of general laboratory training or experience;

(g) Was qualified as a clinical laboratory director under federal regulations prior to February 28, 1992.

(2) A person is qualified to act as the laboratory Director of the clinical laboratory only at any accredited chiropractic college in this State for the benefit of chiropractic patients if that person is a chiropractic physician licensed by the State Board of Chiropractic Examiners, and possesses special qualifications, as determined by the State Board of Chiropractic Examiners, which enable that person to perform as a laboratory Director.

(3) The Director shall supervise or perform only in those specialties for which qualified.

(4) The 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 supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities in writing to other qualified individuals; and 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 laboratory director must ensure:

(A) Quality services for all 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) That a general supervisor provides on-site supervision of high complexity test performance by qualified testing personnel;

(N) 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;

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

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

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

(R) All personnel have appropriate training.

Or. Admin. Code § 333-024-0021

HB 248, f. 6-30-70, ef. 7-25-70; HD 28-1988, f. & cert. ef. 12-7-88; Renumbered from 333-024-0015; 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