OAR 333-024-0043
Quality Assurance

(1)

Each laboratory performing physician performed microscopy, moderate or high complexity testing must establish and follow written policies and procedures for a comprehensive quality assurance program which is designed to monitor and evaluate the ongoing and overall quality of the total testing process (pre-analytic, analytic, post-analytic).

(2)

The laboratory’s quality assurance program must evaluate the effectiveness of its policies and procedures; identify and correct problems; assure the accurate, reliable and prompt reporting of test results; and assure the adequacy and competency of the staff.

(3)

The laboratory must meet the requirements of this rule as they apply to the services offered, complexity of testing performed, test results reported, and the unique practices of each testing entity.

(4)

The laboratory must monitor, evaluate, and revise, if necessary, based on the results of its evaluations, the following:

(a)

The criteria established for patient preparation, specimen collection, labeling, preservation and transportation;

(b)

The information solicited and obtained on the laboratory’s test requisition for its completeness, relevance, and necessity for the testing of patient specimens;

(c)

The use and appropriateness of the criteria established for specimen rejection;

(d)

The completeness, usefulness, and accuracy of the test report information necessary for the interpretation or utilization of test results;

(e)

The timely reporting of test results based on testing priorities (STAT, routine, etc.); and

(f)

The accuracy and reliability of test reporting systems, appropriate storage of records and retrieval of test results.

(5)

The laboratory must have an ongoing mechanism to evaluate the corrective actions taken under remedial action.

(6)

Ineffective policies and procedures must be revised based on the outcome of the evaluation. The mechanism must evaluate and review the effectiveness of corrective actions taken for:

(a)

Problems identified during the evaluation of calibration and control data for each test method;

(b)

Problems identified during the evaluation of patient test values for the purpose of verifying the reference range of a test method; and

(c)

Errors detected in reported results.

(7)

The corrective actions taken for any unacceptable, unsatisfactory, or unsuccessful proficiency testing result(s) must be evaluated for effectiveness.

(8)

If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.

(9)

If a laboratory performs tests that are not included in an approved proficiency testing program, the laboratory must have a system for verifying the accuracy of its test results at least twice a year.

(10)

The laboratory must have a mechanism to identify and evaluate patient test results that appear inconsistent with relevant criteria including:

(a)

Patient age;

(b)

Sex;

(c)

Diagnosis or pertinent clinical data, when provided;

(d)

Distribution of patient test results, when available; and

(e)

Relationship with other test parameters, when available within the laboratory.

(11)

The laboratory must have an ongoing mechanism to evaluate the effectiveness of its policies and procedures for assuring employee competence and, if applicable, consultant competence:

(a)

The assessment of employee competence must be biannually the first year of employment; and

(b)

Annually thereafter.

(12)

The laboratory must have a system in place to document problems that occur as a result of breakdowns in communication between the laboratory and the authorized individual who orders or receives the results of test procedures or examinations; Corrective actions must be taken and documented, as necessary, to resolve the problems and minimize communications breakdowns.

(13)

The laboratory must have a system in place to assure that all complaints and problems are documented. Investigations of complaints must be made and appropriate corrective actions instituted.

(14)

The laboratory must have a mechanism for documenting and assessing problems identified during quality assurance reviews and discussing them with the staff. The laboratory must take corrective actions necessary to prevent recurrences.

(15)

The laboratory must maintain documentation of all quality assurance activities including problems identified and corrective actions taken.

(16)

All quality assurance records must be available to the Division and maintained for a period of 2 years.

Source: Rule 333-024-0043 — Quality Assurance, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0043.

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 333-024-0043’s source at or​.us