Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.290 - Standard - Laboratory Report and Record
Current through Register 1518, March 29, 2024
The laboratory report shall be sent promptly to the licensed physician or other authorized person who requested the test and a suitable record of each test result shall be preserved by the laboratory for a period of at least four years after the date of submittal of the report. Minimum requirements are as follows:
(A) The final laboratory report shall bear the name or identification of the laboratory performing the test.
(B) The laboratory director is responsible for the laboratory report and for maintaining the confidentiality of patient information and results of testing and for maintaining within the laboratory the confidentiality of patient information and results of testing.
(C) Duplicate copies or a suitable record of laboratory reports shall be filed in the laboratory in a manner which permits ready identification and accessibility.
(D) Tissue pathology reports shall utilize acceptable terminology of a recognized system of disease nomenclature.
(E) The result of laboratory tests, including procedures or transcripts of results, shall not be sent directly to the patient concerned except with the written consent of the physician or other authorized person who requested the test.
(F) Pertinent "reference" ranges as determined by the laboratory performing the tests shall be available to the legally authorized individuals requesting such tests.
(G) All laboratories shall provide a system designed to assist both the laboratory and the physician in the detection of matrix errors which affect all clinical laboratory tests performed. This system shall include the detection of matrix errors due to interfering substances of both endogenous nature (e.g. metabolites) and exogenous nature (e.g. drugs).
(H) A list of tests performed in the laboratory, analytical methods for each and a basis for the listed "reference" range shall be maintained in the laboratory. The list shall be made available to any authorized individual ordering an examination upon request.
(I) If the laboratory refers specimens to another laboratory, the laboratory receiving the specimens shall meet the applicable conditions in state or federal laboratory certification or licensure programs.
(J) Each authorized person ordering an examination shall be notified if the specimen is referred to another laboratory. Such notice shall show the name, address and other relevant identification of the laboratory to which the specimen is referred. If the authorized person so requests, the referring laboratory may allow the testing laboratory to report directly to the authorized person who originally requested the test. In the event of such direct reporting the testing laboratory shall send a duplicate of the report to the referring laboratory.
