Or. Admin. Code § 333-024-0050

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

Section 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 through 333-018-0015, 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.

Or. Admin. Code § 333-024-0050

HB 248, f. 6-30-70, ef. 7-25-70; HD 28-1988, f. & cert. ef. 12-7-88; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; OHD 11-2001, f. & cert. ef. 5-16-01, 333-024-0050(5) Renumbered to 333-018-0018

Stat. Auth.: ORS 438.310

Stats. Implemented: ORS 438.310