Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.04 - Reporting and Releasing Test Results
Universal Citation: MD Code Reg 10.10.06.04
Current through Register Vol. 51, No. 19, September 20, 2024
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 patient's primary care practitioner for evaluation and
treatment; or
(b) The patient with
a referral to a licensed independent practitioner for evaluation and
treatment.
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