OAR 333-024-0050
Records and Reports

(1)

Personnel policies, practices, and procedures that support sound laboratory practice shall be available in written form. A current record shall be maintained on each employee and shall include a resume of training and experience.

(2)

Complete records for each specimen examined, including quality control, shall be kept for not less than two years, immunohematology records not less than five years, cytology and pathology records not less than ten years. Such records shall contain:

(a)

Laboratory number or other identification of the specimen;

(b)

The name or other identifier of the person from whom the specimen was taken, if available;

(c)

The name of the physician or other authorized person or clinical laboratory submitting the specimen;

(d)

The date and time the specimen was collected or date and time it was received in the laboratory;

(e)

The type of test performed;

(f)

The results of the tests in units of measurement where applicable;

(g)

The signature, initials, or identification of the examiner;

(h)

The date and time the test results were reported; and

(i)

Other information as needed to aid in the interpretation of laboratory results.

(3)

Cytology slides must be maintained for a minimum of 5 years, histology slides 10 years, and tissue blocks 2 years.

(4)

The Owner or Director of each clinical laboratory licensed under the Act shall report communicable disease according to OAR 333-018-0000 (Who Is Responsible for Reporting) through 333-018-0015 (What Is to Be Reported and When), and shall maintain a separate log of such reporting:

(a)

Reports shall not be interpreted as constituting a diagnosis nor shall any laboratory making such report be held liable under the laws of this State for having violated a trust or confidential relationship;

(b)

Information contained in such reports may be used in compiling statistical and other data in which persons are not identified by name or otherwise.

(5)

Requests for examinations of specimens and reporting of test results shall be as follows:

(a)

The clinical laboratory shall examine specimens only at the oral, written or electronic request of a physician, dentist or other person authorized by law to use the findings of laboratory examinations;

(b)

Oral requests for laboratory tests are permitted only if the laboratory subsequently requests written authorization for testing within 30 days;

(c)

No person shall report the result of any test, examination, or analysis of a specimen submitted for evidence of human disease except to a physician, dentist, their agents, or other person authorized by law to employ the results thereof in the conduct of their practice or in the fulfillment of their official duties. Reports shall not be issued to the patient concerned except with the written consent of the physician or other authorized person;

(d)

The clinical laboratory may examine specimens for substance of abuse submitted by persons other than medical personnel authorized by law and shall report the result of any test to the person who submitted the specimen.

(6)

The laboratory must maintain the written test authorization or documentation of efforts made to obtain a written authorization for a minimum of two years.

(7)

The laboratory must assure that the requisition or test authorization includes:

(a)

The name and address or other identifiers of the authorized person requesting the test or the name and address of the laboratory submitting the specimen;

(b)

For Pap smears, the patient’s last menstrual period, age or date of birth, and indication of whether the patient had a previous abnormal report, treatment or biopsy; and

(c)

Any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results.

(8)

The laboratory must have adequate systems in place to report results in a timely, accurate, reliable and confidential manner.

(9)

The test report must indicate the name and address of the laboratory location at which the test was performed, the test performed, the test result, and if applicable, the units of measurement.

(10)

The laboratory must indicate on the test report any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.

(11)

Pertinent “reference” or “normal” ranges, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests or the individual responsible for utilizing the test results.

(12)

The laboratory must develop and follow written procedures for reporting imminent life-threatening laboratory results or panic values.

(13)

The original report or exact duplicates of test reports must be maintained by the laboratory.

(14)

The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory.

(15)

The referring laboratory may permit each testing laboratory to send an additional test result directly to the authorized person who initially requested the test.

(16)

The authorized person who orders a test or procedure must be notified by the referring laboratory of the name and address of each laboratory location at which a test was performed.

(17)

The test records of the laboratory must include:

(a)

The patient identification number, accession number, or other unique identification of the specimen;

(b)

The condition and disposition of specimens that do not meet the laboratory’s criteria for specimen acceptability;

(c)

The records and dates of all specimen testing, including the identity of the personnel who performed the tests.

(18)

The laboratory must, upon request, make available to clients:

(a)

A list of test methods employed by the laboratory;

(b)

If applicable, the performance specifications of each method used;

(c)

Information that affect the interpretation of test results such as interferences;

(d)

Pertinent updates on testing information whenever changes occur that affect the test results or its interpretation.

(19)

A laboratory must refer specimens only to a Division licensed laboratory authorized to perform testing in that specialty or subspecialty at that complexity level; except referral specimens may be sent to laboratories outside the state of Oregon to a laboratory operating in compliance with the provisions of CLIA 88.

Source: Rule 333-024-0050 — Records and Reports, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0050.

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 333-024-0050’s source at or​.us