Md. Code Regs. 10.10.01.03

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.01.03 - Definitions

A. In this subtitle, the following terms have the meanings indicated.

B. Terms Defined.

(1) Accuracy or Accurate.

(a) "Accuracy" or "accurate" means the degree of agreement between the determination of a quantity and its true value.

(b) "Accuracy" or "accurate" includes the quality of a test result as it relates to the analytic phase of the testing process when the test result:

(i) Conforms exactly to a standard; or

(ii) Deviates only within established limits from a standard.

(2) "Alternative sanction" means a directed plan of correction or a limitation placed on testing.

(3) "Analyte" means a substance or constituent for which a laboratory conducts testing.

(4) "Analytical system" means a test system's methods, procedures, instruments, equipment, kits, reagents, and supporting materials used to detect or measure an analyte or perform a test.

(5) Authorized Person.

(a) "Authorized person" means an individual allowed to request a laboratory test.

(b) "Authorized person" is limited to those individuals identified under COMAR 10.10.06.02C.

(5-1) "Buccal cavity" means the vestibule of the mouth, specifically the area lying between the teeth and cheeks.

(5-2) "Buccal swab" means a specialized applicator with a sponge, cotton, or Dacron tip, used to collect epithelial cells for DNA testing by rubbing the applicator tip on the inside of the cheek in the buccal cavity.

(6) "Calibrator" means a material having a known value or concentration that is used to standardize an analytical system.

(7) "CDC" means the Centers for Disease Control and Prevention.

(8) "Certified analyst" means an individual who:

(a) Meets the qualifications established under COMAR 10.10.09.01BB and .02C; and

(b) Is thereby permitted to identify marijuana or marijuana products, or both, using procedures approved under COMAR 10.10.09.04B.

(9) "Certified chemical analyst" means an individual who:

(a) Meets the qualifications established under COMAR 10.10.09.01AA and .02B; and

(b) Is thereby permitted to identify marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under COMAR 10.10.09.04A.

(10) "Certified chemist" means an individual who:

(a) Meets the qualifications established under COMAR 10.10.09.01AA and .02A; and

(b) Is thereby permitted to identify any controlled dangerous substance using procedures approved under COMAR 10.10.09.04A.

(11) "CFR" means the Code of Federal Regulations.

(12) "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988 in Section 353 of the Public Health Service Act and any amendments to it (42 U.S.C. § 263a).

(13) "CMS" means the federal Centers for Medicare and Medicaid Services.

(14) "Collection station" means a site other than a laboratory where specimens are gathered before being shipped elsewhere for laboratory testing.

(15) "Complaint investigation" means an investigation of a laboratory, including an on-site survey, initiated in response to a complaint.

(16) "Control sample" means a material, solution, or lyophilized preparation used in laboratory quality control, the concentration of which is within certain specified and known limits.

(17) "Controlled dangerous substance" means any drug, substance, or immediate precursor in Schedules I through V of Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.

(18) "Deficiency" means a situation or finding of statutory or regulatory noncompliance.

(19) "Department" means the Department of Health and Mental Hygiene.

(20) "Directed plan of correction" means a set of corrective actions stipulated by the Secretary that a laboratory shall implement to effect statutory or regulatory compliance.

(21) Discipline.

(a) "Discipline" means a scientific field of study in which a laboratory is licensed to offer to perform or perform tests.

(b) "Discipline" includes:

(i) Chemistry, including the subdisciplines of blood gas analysis, endocrinology, radioimmunoassay, routine chemistry, toxicology, and urinalysis;

(ii) Forensic toxicology, including job-related alcohol and controlled dangerous substances, limited to the detection of alcohol or a controlled dangerous substance for a non-therapeutic or non-diagnostic, job-related purpose.

(iii) Genetics, including the subdisciplines of biochemical genetics, cytogenetics, medical genetics, and molecular genetics;

(iv) Health awareness testing, which is limited to health awareness tests set forth in §B(27) of this regulation;

(v) Hematology, including the subdisciplines of coagulation testing, hemoglobinopathy screening, and routine hematology;

(vi) Immunology, including the subdisciplines of serology, immunohematology, and histocompatibility;

(vii) Microbiology, including the subdisciplines of bacteriology, mycobacteriology, mycology, parasitology, and virology;

(viii) Molecular biology, including nucleic acid probes; nucleic acid target, probe, and signal amplifications; recombinant nucleic acid techniques; and other techniques of applied molecular genetics other than cytogenetics used in connection with the diagnosis and control of human disease or the assessment of human health; and

(ix) Pathology, including the subdisciplines of gynecologic cytology, dermatopathology, and histopathology.

(22) "Examinee" means an individual:

(a) Whose specimen is collected or tested by a laboratory; or

(b) Who is subject to a proficiency test in gynecologic cytology.

(23) "Excepted laboratory" means a medical laboratory that offers to perform or performs tests limited to one or more excepted tests.

(24) "Excepted test" means a medical laboratory test, as set forth in COMAR 10.10.03.02B, that is authorized by the Secretary to be offered or performed by a laboratory operating under a letter of exception.

(25) "Exfoliative" means falling off in scales or layers.

(26) General Supervisor.

(a) "General supervisor" means a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than an excepted laboratory.

(b) "General supervisor" includes an individual who qualified as a supervisory technologist under previous State regulations.

(27) "HDL-C" means high density lipoprotein cholesterol.

(28) Health Awareness Test.

(a) "Health awareness test" means a test approved by the Secretary to be performed at a temporary or mobile laboratory, such as a health fair in a shopping mall.

(b) "Health awareness test" is limited to tests that:

(i) Are performed solely for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions;

(ii) Are performed on a CLIA waived testing device; and

(iii) Measure glucose, lipids, or other clinical values which the Secretary has concluded are in the interest of public health to be measured at a health awareness event.

(29) "Immediate jeopardy" means a deficiency that poses immediate danger to public health or safety and requires the Secretary to take immediate action to remove the jeopardy.

(30) "Immediate precursor" means a substance that the Department has found to be, and by regulation designates as being, the principal compound commonly used or produced primarily for use and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled dangerous substance, the control of which is necessary to prevent, curtail, or limit that manufacture.

(31) "Laboratory" means a medical laboratory.

(32) "Letter of exception" means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform one or more excepted tests.

(33) "Letter of exception-limited testing for rare diseases" means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform testing limited to one or more rare disease tests.

(34) "License" means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to:

(a) Offer to perform or perform medical laboratory tests or examinations in this State;

(b) Offer to perform or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or

(c) Represent or service in this State a medical laboratory regardless of the laboratory's location.

(35) "Licensed laboratory" means a laboratory operating under a license issued by the Secretary.

(36) "Licensee" means a person who holds a license under this chapter to operate a laboratory.

(37) "Limited public health testing" means testing limited to a combination of 15 or fewer excepted tests performed by a nonprofit organization or a State, county, or local health department.

(38) "Marginal proficiency testing performance" means failure to attain the minimum satisfactory score for two of three consecutive proficiency testing events.

(39) Medical Laboratory.

(a) "Medical laboratory" means a facility, entity, or site that offers to perform or performs tests in connection with:

(i) The diagnosis and control of human disease;

(ii) The assessment of human health, nutrition, or medical conditions; or

(iii) Job-related testing.

(b) "Medical laboratory" includes but is not limited to a:

(i) Physician office laboratory;

(ii) Point-of-care laboratory;

(iii) Laboratory owned or operated by the State, a county, or a municipal health department;

(iv) Not-for-profit laboratory;

(v) Hospital laboratory; and

(vi) Commercial laboratory.

(40) Method Verification.

(a) "Method verification" means evaluation of an analytical system by assessment of each analytical system component, including instrument, test strip, cartridge, card, and kit reagent.

(b) "Method verification" includes but is not limited to the determination of:

(i) An analytical system's reportable range;

(ii) Accuracy; and

(iii) Within-run and run-to-run precision.

(41) "Mobile laboratory" means a laboratory located in a moveable vehicle, such as a truck, trailer, van, or ambulance.

(42) "Multi-site permit" means a permit available to the State, a county, or a municipal health department authorizing the operation of limited public health testing at more than one mobile or permanent laboratory.

(43) "Office of Health Care Quality (OHCQ)" means the Office of Health Care Quality of the Department of Health and Mental Hygiene, formerly the Licensing and Certification Administration (LCA).

(44) "Operator of an analytical system" means an individual who applies a test specimen or control sample to an analytical system and performs the necessary operative steps to isolate or identify an infectious agent or measure an analyte.

(45) "Owner" means a person who possesses a financial interest in a laboratory.

(46) "Patient of the practice" means an individual who accepts referral to or is seen or otherwise examined by a member or members of a practice of medicine.

(47) Permit.

(a) "Permit" means a license issued by the Secretary authorizing a person to operate a medical laboratory conducting one or more tests that are not excepted tests.

(b) "Permit" includes a:

(i) Provisional permit; and

(ii) Temporary permit.

(48) "Permitted laboratory" means a licensed laboratory operating under a permit.

(49) "Phlebotomist" means an individual who procures a blood specimen by venipuncture, arterial puncture, or capillary sampling.

(50) "Physician" means a doctor of medicine or a doctor of osteopathy licensed by the Maryland State Board of Physicians and a doctor of podiatric medicine licensed by the Maryland State Board of Podiatric Medical Examiners.

(51) "Physician of a practice" means a physician employed, salaried, or otherwise engaged to operate or function as a member in a medical practice, even if the physician does not have an ownership interest in the practice or the practice's laboratory.

(52) "Physician office laboratory (POL)" means a medical laboratory operated by a single practice of medicine, individually or collectively by one or more physicians, that is used solely as an adjunct to the care of patients of the practice.

(53) "Point-of-care laboratory (POCL)" means a laboratory operated as part of, or in association with, a medical care facility, such as a hospital, nursing home, community health center, health maintenance organization, county or municipal health department, or a pharmacy.

(54) "Practice" means:

(a) An individual physician licensed to practice medicine in the State; or

(b) A medical partnership, professional association, professional service corporation, or medical corporation of two or more physicians licensed to practice medicine in the State and sharing facilities, personnel, income, or business expenses.

(55) "Precision" means the agreement of results among themselves when a specimen or sample is tested multiple times.

(56) "Pre-field evaluation" means the assessment of an analytical system before it may be used in a mobile or temporary laboratory.

(57) "Primary standard" means a comprehensive general standard or set of standards that:

(a) A laboratory must meet to obtain or retain a license to operate; or

(b) An individual must meet in order to examine gynecologic cytology specimens.

(58) "Principal sanction" means the denial, suspension, or revocation of a license.

(59) "Proficiency testing (PT)" means evaluation of an individual's ability to perform laboratory procedures or tests within the PT program's defined limits of accuracy through analysis of unknown samples distributed at periodic intervals by an external source.

(60) "Public health laboratory" means a public, nonprofit laboratory solely owned and operated by or for the State, a county, or a municipal health department located in the State.

(61) Quality Assurance.

(a) "Quality assurance" means a system of established written policies and procedures designed to monitor, review, evaluate, and improve the ongoing and overall quality of the preanalytic, analytic, and postanalytic aspects of laboratory testing.

(b) "Quality assurance" includes but is not limited to practices involving:

(i) Patient preparation;

(ii) Specimen collection, labeling, processing, and transport;

(iii) Quality control strategies, practices, and results;

(iv) Record keeping;

(v) Personnel training and competency;

(vi) Continuing education;

(vii) Proficiency testing;

(viii) Remedial and corrective actions; and

(ix) Analytical system evaluation, validation, and verification.

(62) Quality Control.

(a) "Quality control" means established written policies and procedures designed to ensure reliable laboratory testing by monitoring, reviewing, and evaluating the analytic aspects of laboratory testing.

(b) "Quality control" includes but is not limited to policies and procedures that detect, monitor, review, and evaluate the:

(i) Accuracy and precision of the analytic phase of a testing process;

(ii) Changes in the chemical, electronic, optical, or mechanical components of an analytical system;

(iii) Deterioration of reagents, materials, or supplies used in a testing process; and

(iv) Personnel practices during a testing process.

(63) "Quality control test" means an examination performed on an external test sample that:

(a) Is not part of the analytical system;

(b) Contains a known quantity of the analyte being tested;

(c) Is similar in its physical characteristics and constituents to patient specimens tested by the system; and

(d) Reacts with all system components in the same way as a patient specimen.

(64) "Rare disease" means:

(a) A disabling, chronically debilitating, or life-threatening disease or condition that has fewer than 200,000 affected individuals in the United States, which is equivalent to:

(i) A prevalence of fewer than one individual per 2,000 individuals in the population; or

(ii) An incidence of fewer than one affected individual per 10,000 individuals in the population;

(b) A disabling or life-threatening disease or condition that is listed as a rare disease by the National Institutes of Health Office of Rare Diseases; or

(c) A disabling or life-threatening disease or condition in which more than 200,000 individuals are affected if:

(i) A subpopulation of the disease or condition is equal to the prevalence standard for a rare disease in §B(64)(a) of this regulation; or

(ii) The incidence of the disease or condition is fewer than five affected individuals per 10,000 in a defined community.

(65) Rare Disease Test.

(a) "Rare disease test" means a test that is:

(i) Performed on a specimen obtained from an individual in order to determine or evaluate whether the individual has a rare disease or condition;

(ii) Based on a single method using one sample of a specimen to produce the test result; and

(iii) Not routinely offered or performed by a medical laboratory permitted by the Department.

(b) "Rare disease test" includes a test with multiple clinical or health evaluation uses such as:

(i) Newborn screening;

(ii) Carrier screening;

(iii) Predictive testing;

(iv) Disease diagnosis; or

(v) Disease prognosis.

(66) "Reliable" means that the quality of a test result meets the quality standards for the preanalytic, analytic, and postanalytic phases of the testing process as set forth in COMAR 10.10.06.

(67) "Remeasurement" means repeating the measurement of an analyte.

(68) "Sample" means a substance, constituent, or material intended for use in quality control, proficiency testing, or another aspect of a laboratory's quality assurance program.

(69) Sanction.

(a) "Sanction" means an action that the Secretary may take to effect statutory or regulatory compliance.

(b) "Sanction" includes a principal sanction and an alternative sanction.

(70) Secretary.

(a) "Secretary" means the Secretary of Health and Mental Hygiene or the Secretary's designee.

(b) "Secretary" includes the Office of Health Care Quality as a designee.

(71) "Single-use test device for forensic testing" means the reagent-containing unit of a test system that:

(a) Is in the form of a sealed container or cartridge possessing a validity check;

(b) Possesses a nonresealable closure or an evidentiary tape to ensure detection of tampering;

(c) Is self-contained and individually packaged;

(d) Is discarded after each test; and

(e) Does not allow any test component or constituent of a test system to interact from test to test.

(72) "Single-use test device for nonforensic testing" means the reagent-containing unit of a test system in the form of a cartridge, test pack, or other container that:

(a) Includes a validity check;

(b) Is self-contained and individually packaged;

(c) Is discarded after each test; and

(d) Does not allow any test component or constituent of a test system to interact from test to test.

(73) "SOPM" means a standard operating procedure manual.

(74) "Specialty" means a scientific field of study within a laboratory subdiscipline, such as compatibility testing within the subdiscipline of immunohematology.

(75) "Specimen" means material collected from the human body and intended for laboratory testing.

(76) "Standard" means one or more specific technical, procedural, fiscal, or other requirements that a laboratory or individual must meet to comply with this chapter.

(77) "Subdiscipline" means a scientific field of study within a laboratory discipline, such as bacteriology within the discipline of microbiology and dermatopathology within the discipline of pathology.

(78) Survey.

(a) "Survey" means an on-site visit to a laboratory by one or more employees of the OHCQ to carry out or oversee the regulation of medical laboratories.

(b) "Survey" includes but is not limited to:

(i) Inspection;

(ii) Follow-up inspection;

(iii) Complaint investigation; and

(iv) On-site monitoring.

(79) System Check.

(a) "System check" means a device that verifies all or part of the chemical, electronic, optical, or mechanical components or constituents of a test system to determine if the test system is functioning properly.

(b) "System check" includes chemical, electronic, optical, or mechanical devices, such as a card, tube, or strip that simulates a properly functioning single-use test device.

(c) "System check" does not include a quality control test sample or patient specimen.

(80) "Technical supervisor" means an individual who is qualified to direct medical laboratory testing in at least one laboratory discipline.

(81) "Technician" means an individual who has at least 1 year of experience in a licensed medical laboratory, other than an excepted laboratory, and who has earned:

(a) An associate degree in a laboratory science or medical laboratory technology from an accredited college or university; or

(b) 60 semester hours of academic credit, including 24 semester credit hours of science that include:

(i) 6 semester hours of chemistry, and

(ii) 6 semester hours of biology.

(82) "Technologist" means an individual who:

(a) Possesses a bachelor's degree in a chemical, physical, biological, or clinical laboratory science or in medical technology from an accredited college or university and has at least 1 year of full-time laboratory experience in the discipline in which the individual performs tests;

(b) Received a passing score in the United States Department of Health and Human Services proficiency examination for clinical laboratory technologists; or

(c) Meets the technologist qualifications set forth in 42 CFR § 493.1491, which is incorporated by reference in Regulation .04 of this chapter.

(83) "Temporary laboratory" means a medical laboratory located at a temporary testing site, such as a health fair or shopping mall, for fewer than 30 days in 12 consecutive months.

(84) "Test" means a medical laboratory examination, analysis, procedure, or preanalytic, analytic, or postanalytic phase of a testing process.

(85) "Testing event" means an occasion when a health awareness test is offered or performed on a specified date at a temporary laboratory.

(86) "Testing personnel" means an individual or individuals employed or otherwise engaged by a laboratory to perform medical laboratory tests.

(87) "Total number of tests" means all tests performed by a laboratory in all disciplines in the previous calendar year.

(88) "Unsatisfactory proficiency testing performance" means failure to attain the minimum satisfactory score for three of four consecutive proficiency testing events.

(89) "Validity check" means a procedural, testing process, or analytical verification of proper performance of one or more analytical steps performed by the test system operator, built into a single-use test device, and carried out by a single-use test device to detect environmental damage or interfering substances that may have affected the device or the results of the testing process.

Md. Code Regs. 10.10.01.03

Regulation .03N amended effective December 28, 1987 (14:26 Md. R. 2747)
Regulation .03 amended as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305)
Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 23, 2002 (29:25 Md. R. 1982); June 1, 2009 (36:11 Md. R. 787); January 13, 2011 (38:1 Md. R. 11); April 16, 2012 (39:7 Md. R. 492); April 1, 2013 (40:6 Md. R. 473)