OAR 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 (Qualifications and Responsibilities of Directors for High Complexity Laboratories) 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.

Source: Rule 333-024-0022 — Qualifications and Responsibilities for Director of Moderate Complexity Laboratories, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0022.

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 333-024-0022’s source at or​.us