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Session Laws, 1995
Volume 793, Page 2668   View pdf image
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Ch. 465                                    1995 LAWS OF MARYLAND

(2) MEETS THE EXCEPTION REQUIREMENTS IN REGULATIONS
ADOPTED BY THE SECRETARY PURSUANT TO THIS SUBTITLE.

(c) [(l)]For the purposes, of this section, "limited MEDICAL laboratory TESTS
OR examinations" means simple MEDICAL laboratory [examinations and] procedures
[that] AS DEFINED IN REGULATIONS ADOPTED BY THE SECRETARY PURSUANT TO
THIS SUBTITLE [have an insignificant risk of an erroneous result].

[(2) "Limited laboratory examinations" includes, but is not limited to:

(i) 1.      Dermatophyte screen;

2.       Dipstick glucose;

3.       Dipstick urinalysis;

4.       Gram stain;

5.       Group "A" streptococcal screen;

6.       Hematocrit;

7.       Hemoglobin;

8.       Infectious mononucleosis slide or card test;

9.       Microscopic urinalysis;

10.     Occult blood;

11.     Pinworms;

12.     Potassium hydroxide skin preparations;

13.     Rheumatoid factor slide agglutination test;

14.     Sickle-cell screen;

15.     Urine bacteria colony count;

16.     Urine pregnancy slide test; and

17.     Wet mounts; or

(ii) 1. Examinations and procedures that have been approved by
the Food and Drug Administration for home use;

2.       Methodologies that are so simple and accurate as to render
the likelihood of erroneous results negligible; and

3.       Examinations and procedures that the Secretary determines
pose no reasonable risk of harm to the patient if performed incorrectly.]

17-206.

To qualify for a [permit] LICENSE, an applicant shall PROVIDE EVIDENCE TO
satisfy the Secretary that the medical laboratory [to be operated, represented, or

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Session Laws, 1995
Volume 793, Page 2668   View pdf image
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