Sec. 10.10.03.02. Letters of Exception

A. Eligibility.

(1) An individual directing a POL or POCL who offers to perform or performs tests limited to one or more excepted tests may obtain a letter of exception instead of a permit to offer to perform or perform those tests.

(2) An individual eligible for a letter of exception shall:

(a) Be qualified as a laboratory director as set forth in 42 CFR §493.1405, including:

(i) Being a doctor of medicine or doctor of osteopathy licensed in the State and having laboratory training or experience appropriate for the testing performed; or

(ii) Holding an earned doctoral, master's, or bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution;

(b) Provide evidence of training in the performance and interpretation of excepted tests and be licensed in the State as a:

(i) Nurse midwife;

(ii) Nurse practitioner;

(iii) Physician assistant;

(iv) Chiropractor;

(v) Podiatrist;

(vi) Dentist; or

(vii) Pharmacist; or

(c) Be clinical staff who:

(i) Meets the qualifications set forth in COMAR 10.47.01.06D;

(ii) Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and

(iii) Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program.

(3) A person operating a temporary medical laboratory to perform health awareness tests, regardless of testing site location, is not eligible for a letter of exception.

B. Excepted Tests. A POL or POCL operating under a letter of exception may perform one or more of the following excepted tests or types of tests:

(1) Whole blood glucose by glucose monitoring devices cleared by the FDA for home use or a CLIA waived analyzer;

(2) Dermatophyte screen;

(3) Dipstick glucose;

(4) Dipstick urinalysis using reagent test pads affixed to plastic strips that detect one or a combination of any of the following urine characteristics or constituents:

(a) Glucose;

(b) Bilirubin;

(c) Ketones detected in the form of acetoacetic acid;

(d) Specific gravity;

(e) Red blood cells or hemoglobin;

(f) pH;

(g) Protein;

(h) Urobilinogen;

(i) Nitrites; and

(j) Leukocytes;

(5) Gram stain;

(6) Group A streptococcal screen;

(7) Hematocrit;

(8) Hemoglobin;

(9) Infectious mononucleosis slide or card test;

(10) Microscopic urinalysis;

(11) Occult blood;

(12) Pinworms;

(13) Potassium hydroxide skin preparations;

(14) Rheumatoid factor slide agglutination test;

(15) Sickle-cell screen;

(16) H. pylori test with a single-use test device for nonforensic testing, using a whole-blood specimen;

(17) Fructosamine test with a single-use test device for nonforensic testing, using a whole-blood specimen;

(18) Heterophile antibodies test with a single-use test device for nonforensic testing, using a whole-blood specimen;

(19) Urine bacteria colony count;

(20) Urine pregnancy test;

(21) Wet mounts;

(22) Influenza antigen test using a direct nasal or throat swab specimen;

(23) Hemoglobin A1c test using a whole blood specimen;

(24) Qualitative test for bladder cancer markers in voided urine including a test to detect:

(a) Human complement factor H-related protein; or

(b) Nuclear mitotic apparatus protein (NMP);

(25) Brain natriuretic peptide (BNP) test using a whole blood specimen to detect:

(a) Heart disease; or

(b) The response of treatment for heart failure;

(26) Fern test for qualitative detection of:

(a) Amniotic fluid crystallization; or

(b) Estrogenic activity;

(27) Qualitative semen analysis, limited to detecting:

(a) The presence or absence of sperm; or

(b) Sperm motility;

(28) Nitrazine vaginal pH test using phenaphthazine reagent paper strips;

(29) Qualitative immunochromatographic test to detect the presence of adenovirus antigens directly from eye fluid;

(30) Microalbumin-creatinine urinalysis test utilizing an instrument based dip-and-read reagent test strip for determining urine albumin and creatinine levels, including the urinary albumin-to-creatinine ratio (UACR) in a random urine specimen;

(31) Screening tests for urine or saliva performed on FDA-cleared for home use or FDA approved single-use test devices for the presence of alcohol and drugs of abuse solely for the purpose of directing patient counseling;

(32) Qualitative enzyme activity test using a chromogenic substrate of bacterial sialidase for use in the detection of bacterial vaginosis directly from vaginal fluid specimens;

(33) Qualitative immunochromatographic test to detect the presence of Trichomonas vaginalis antigens directly from a vaginal swab;

(34) CLIA-waived Prothrombin Time/International Normalized Ratio (PT/INR) with the additional requirements that:

(a) The licensee shall enroll into a Proficiency Testing program offered by an entity that has been approved by the Centers for Medicare and Medicaid Services (CMS) to ensure validation of all measurement capabilities for the instrument used to perform the test; and

(b) When the numerical score is less than 80 percent, the licensee shall submit the official proficiency test results to the Office of Health Care Quality for review and monitoring with evidence of documented remedial actions taken;

(35) CLIA waived blood lipid analysis for cholesterol, HDL, LDL, and triglycerides;

(36) Whole blood lead testing on a CLIA waived analyzer with the additional requirements:

(a) The licensee shall enroll into a Proficiency Testing program offered by an entity that has been approved by the Centers for Medicare and Medicaid Services to ensure validation of all measurement capabilities for the instrument used to perform the test;

(b) When the numerical score is less than 80 percent, the licensee shall submit the official proficiency test result to the Office of Health Care Quality for review and monitoring with evidence of documented remedial actions taken;

(c) All staff involved in testing shall undergo training on the testing device and testing techniques with annual competencies;

(d) Records of training and competencies for staff shall be:

(i) Maintained by the laboratory; and

(ii) Made available for review by the Department; and

(e) Reporting requirements stated in §C of this regulation shall be followed; and

(37) CLIA Waived Urine Drug Screens with the following additional requirements:

(a) The licensee shall enroll into a proficiency testing program offered by an entity that has been approved by the Centers for Medicare and Medicaid Services; and

(b) When the numerical score is less than 80 percent, the licensee shall submit the official proficiency test result to the Office of Health Care Quality for review and monitoring with evidence of documented remedial actions taken.

C. Reporting Requirements for Whole Blood Lead Testing on a CLIA Waived Analyzer.

(1) The blood tests for lead shall:

(a) Be reported under this regulation in the format approved by the Maryland Department of the Environment; and

(b) Include the information required by this regulation.

(2) The blood tests for lead to be reported shall include the following information:

(a) Demographic information including:

(i) Name, including first, last, middle initial;

(ii) Date of birth, sex, and race;

(iii) Complete home address at the time the blood specimen was drawn including house or apartment number, street, city, county or town, zip code, and state;

(iv) Telephone number; and

(v) Parent or guardian name;

(vi) Residential status, for example, whether parent or guardian owns their home or rents;

(b) Type of specimen, either venous or capillary, and date the specimen was drawn;

(c) Clinic or practice name, address, and telephone number;

(d) Draw site name and address, if different from clinic or practice;

(e) Blood lead level in micrograms per deciliter; and

(f) Any additional information as may be required by the Maryland Department of the Environment.

D. Regulatory Requirements. An individual required to obtain a license to operate a laboratory who chooses to operate under a letter of exception shall:

(1) Obtain, complete, and file an application as prescribed in Regulation .04 of this chapter; and

(2) Comply with good laboratory practices that include:

(a) Following the manufacturer's instructions for instrument or test system operation and test performance;

(b) Having a procedure manual describing the processes for performing tests and reporting patient test results;

(c) Performing and documenting quality control procedures using applicable levels of control materials each day of testing;

(d) Performing and documenting that remedial action has been taken when problems or errors are identified;

(e) Documenting lot numbers of all quality control reagents used; and

(f) Performing and documenting test system function for instruments with internal quality controls on each day of testing.