Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 3. |
Subtitle 10. LABORATORIES |
Chapter 10.10.06. Medical Laboratories—Quality Assurance |
Sec. 10.10.06.04. Reporting and Releasing Test Results
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A. Primary Standard. A laboratory shall report or release test results, except results of a health awareness test, only to an authorized person.
B. Standards.
(1) For all test results except those from a health awareness test performed at a temporary laboratory or from a job-related alcohol or controlled dangerous substance test, a licensee shall ensure that the laboratory:
(a) Reports medical test results only to the physician, dentist, or other authorized person who requested the test, or to another laboratory that requested the test;
(b) Sends a copy of a test result, other than a result for a health awareness or job-related alcohol or controlled dangerous substances test, directly to the individual tested only after the laboratory:
(i) Receives a written request from the individual; and
(ii) Notifies the authorized person who requested the test that the results will be released to the individual tested;
(c) Meets the applicable standards concerning test reports contained in 42 CFR §§493.1234 and 493.1291; and
(d) Reports a test result on a form that identifies the name and address of the laboratory that performed the test.
(2) For test results stemming from a health awareness test, set forth in COMAR 10.10.01.03B, and performed at a temporary laboratory, the laboratory may report those results directly to the individual tested.
(3) If the results of the tests listed in Regulation .02B(7) of this chapter are not within the desired range, the pharmacist shall provide:
(a) The test results to the patients primary care practitioner for evaluation and treatment; or
(b) The patient with a referral to a licensed independent practitioner for evaluation and treatment.