# COMAR Title 10 — Maryland Department of Health ## Subtitle 10 — Laboratories ### Chapter 01 — General **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501; Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1969 **Administrative History:** Chapter revised effective March 2, 1977 (4:5 Md. R. 372) **Administrative History:** Chapter revised effective February 10, 1986 (13:3 Md. R. 271) **Administrative History:** Regulation .03N amended effective December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** Regulation .06 amended effective December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** Chapter revised effective October 30, 1989 (16:21 Md. R. 2261) **Administrative History:** Chapter revised effective October 29, 1990 (17:21 Md. R. 2529) **Administrative History:** 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) **Administrative History:** Regulations .05, .10—.12, .15, and .18 amended and new Regulation .20 adopted as an emergency provision effective May 1, 1992 (19:10 Md. R. 926) Regulation .05A amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .10B amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .12 amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .14 repealed and new Regulation .14 adopted as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .15 repealed and new Regulation .15 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .18C amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .20 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** 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) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** 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); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 Purpose. *COMAR 10.10.01.01* The people of Maryland are entitled to the highest level of competency, reliability, and accuracy that reasonably may be expected from a medical laboratory or crime laboratory. It is the intent of this subtitle to protect the public and individual health by requiring a medical laboratory or crime laboratory to employ qualified personnel and to operate under reliable procedures, effective quality control and quality assurance programs, and qualified supervision. #### Regulation .02 Scope. *COMAR 10.10.01.02* A. This subtitle contains the standards and requirements that a medical laboratory shall meet to: (1) Obtain and retain a license to offer to perform or perform tests on human specimens; and (2) Certify chemists and analysts in crime laboratories to perform approved testing procedures for controlled dangerous substances. B. This subtitle does not apply to: (1) A research facility that tests human specimens and does not: (a) Report any patient-specific test results for use in connection with the diagnosis and control of human disease or the assessment of the health, nutritional, or medical condition or job-related alcohol and controlled dangerous substances evaluation of individual patients or clients, or (b) Provide test results to the patient, the patient's family, or a health care provider; (2) A medical laboratory operated by the federal government, unless the laboratory or tissue bank is directed by a federal agency to meet the requirements of this subtitle; and (3) A crime laboratory operated by the federal government. #### Regulation .03 Definitions. *COMAR 10.10.01.03* 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 10.10.06.02. (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 10.10.09.01B and .02C; and (b) Is thereby permitted to identify marijuana or marijuana products, or both, using procedures approved under COMAR 10.10.09.04. (9) “Certified chemical analyst” means an individual who: (a) Meets the qualifications established under COMAR 10.10.09.01A 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 10.10.09.04. (10) “Certified chemist” means an individual who: (a) Meets the qualifications established under COMAR 10.10.09.01A and .02A; and (b) Is thereby permitted to identify any controlled dangerous substance using procedures approved under COMAR 10.10.09.04. (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). (12-1) “CLIA waived test” means a test system, assay, or examination that the federal Department of Health and Human Services has determined meets the Clinical Laboratory Improvement Amendments (CLIA) statutory criteria as specified for waiver under the federal CLIA Amendments of 1988 in Section 353 of the Public Health Service Act of 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 Maryland Department of Health. (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 that is a CLIA waived test. (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 Maryland Department of Health, 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 or the Secretary's designee. (b) “Secretary” includes the Office of Health Care Quality as a designee. (71) “SOPM” means a standard operating procedure manual. (72) “Specialty” means a scientific field of study within a laboratory subdiscipline, such as compatibility testing within the subdiscipline of immunohematology. (73) “Specimen” means material collected from the human body and intended for laboratory testing. (74) “Standard” means one or more specific technical, procedural, fiscal, or other requirements that a laboratory or individual must meet to comply with this chapter. (75) “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. (76) 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. (77) 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. (78) “Technical supervisor” means an individual who is qualified to direct medical laboratory testing in at least one laboratory discipline. (79) “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. (80) “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. (81) “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. (82) “Test” means a medical laboratory examination, analysis, procedure, or preanalytic, analytic, or postanalytic phase of a testing process. (83) “Testing event” means an occasion when a health awareness test is offered or performed on a specified date at a temporary laboratory. (84) “Testing personnel” means an individual or individuals employed or otherwise engaged by a laboratory to perform medical laboratory tests. (85) “Total number of tests” means all tests performed by a laboratory in all disciplines in the previous calendar year. (86) “Unsatisfactory proficiency testing performance” means failure to attain the minimum satisfactory score for three of four consecutive proficiency testing events. (87) “Test System” means the instructions, instrumentation, equipment, and reagents necessary to perform an assay or examination that generates test results. (88) “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 test system, and carried out by a test system to detect environmental damage or interfering substances that may have affected the device or the results of the testing process. #### Regulation .04 Incorporation by Reference. *COMAR 10.10.01.04* A. In this subtitle, the following documents are incorporated by reference. B. Documents Incorporated. (1) 29 CFR §1910.1030, as amended. (2) 29 CFR §1910.1450, as amended. (3) 42 CFR §§493.801—493.959, as amended. (4) 42 CFR §§493.1100—493.1299, as amended. (5) 42 CFR §§493.1405—493.1495, as amended. (6) 49 CFR §40.87, as amended. (7) Forensic Chemists and Analysts Training and Procedure Manual (Maryland Department of Health, 1992). ### Chapter 02 — Medical Laboratories — General **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .01E adopted effective January 21, 2002 (29:1 Md. R. 23) **Administrative History:** Regulation .01E amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .01F adopted effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .01F amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02C amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 Responsibilities of the Department. *COMAR 10.10.02.01* A. The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license. B. Surveys. The OHCQ shall: (1) Conduct or oversee an announced or unannounced survey of a laboratory at any time during its hours of operation to assess compliance with applicable sections of Health-General Article, Title 17, Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and (2) Examine, as part of a survey, a laboratory's facilities, equipment, quality assurance records and procedures, operating procedures, personnel and personnel records, proficiency testing, patient reports, and other records and files pertinent and subject to this subtitle. C. Issuance of Licensing Documents. The OHCQ shall: (1) License a person to operate a laboratory by issuing a letter of exception or permit when the laboratory is in compliance with the applicable standards set forth in this subtitle; (2) Issue a license that includes the: (a) Name of the laboratory; (b) Name of the licensee or laboratory director; and (c) Name of the laboratory owner. (3) Issue a license that designates: (a) The classes of services, that is, disciplines, provided; (b) The tests or examinations offered; or (c) Both §C(3)(a) and (b) of this regulation. D. Administration and Information Management. The OHCQ shall: (1) Maintain a list of licensed laboratories; (2) Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary; (3) Monitor the proficiency testing performance of a laboratory required to participate in proficiency testing; and (4) For tests that are not CLIA waived, impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a laboratory under the appropriate provisions of this subtitle. E. Recommending Excepted Test Status. #### Regulation .02 Accredited Laboratory and Accrediting Organization. *COMAR 10.10.02.02* A. Accredited Laboratory — Determination. The Secretary shall accept as meeting the survey requirements of this chapter a laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the laboratory's accrediting organization are equivalent to those under this subtitle. B. Accredited Laboratory — Requirements. In addition to meeting the requirements for its certificate of accreditation, as set forth by its accrediting organization, an accredited laboratory shall: (1) Obtain and maintain a valid license issued by the Secretary; and (2) Be subject to survey by the OHCQ for the purpose of investigating complaints or validating findings of the laboratory's accrediting organization. C. Accrediting Organization. (1) A private, nonprofit laboratory accrediting organization may inspect and accredit laboratories in the State for the purpose of Maryland State licensure only after applying for and receiving approval of the OHCQ. (2) The OHCQ shall base approval of a laboratory accrediting organization on a review of that organization, when the review includes but is not limited to an evaluation of: (a) Documentation of current accrediting status issued by CMS and of compliance with CMS reporting requirements; (b) Accreditation policies and standards; (c) Copies of survey forms and guidelines; (d) Surveying and deficiency writing policies; (e) Surveyor qualifications; (f) Complaint investigation policies; (g) Proficiency test monitoring policies; (h) Procedures the accrediting organization will follow when notifying the OHCQ that the organization: (i) Is denying, withdrawing, suspending, or revoking a laboratory's accreditation; (ii) Finds serious patient jeopardy or identifies a hazard to public safety; (iii) Accredits a new laboratory; (iv) Imposes an adverse or corrective action on a laboratory; or (v) Is initiating a complaint investigation; and (i) The accrediting organization's compliance with the requirements of §C of this regulation. (3) In addition to requirements set forth elsewhere in this regulation, an accrediting organization shall: (a) Provide to the OHCQ: (i) Annually, an updated list containing the names, addresses, and accreditation expiration dates of all accredited laboratories in the State; (ii) Within 30 days after conducting a survey, a certified written or electronic copy of each survey report covering each laboratory applying for or maintaining accreditation in the State; (iii) Written notice of any proposed change to requirements for laboratory accreditation, at least 30 days before the effective date of the change; (iv) Within 30 days after a laboratory's certificate of accreditation expires, written or electronic notice when the laboratory does not renew its certificate; and (v) Within 24 hours after taking an action, telephonic or electronic notice whenever an accredited laboratory's certificate of accreditation is limited, suspended, revoked, or surrendered; (b) Evaluate compliance, when applicable, with State regulations pertaining to: (i) Cholesterol testing; (ii) Gynecological cytology; (iii) Dermatopathology; (iv) Forensic toxicology; (v) Laboratory reporting of test results covering contagious disease, blood lead, cancer, and other tests as required by law or regulation; (vi) Proficiency testing; (vii) Special medical waste disposal; and (viii) Testing performed at a temporary or mobile laboratory; (c) Evaluate compliance with State regulations by: (i) Employing a checklist provided by the Department; (ii) Incorporating an evaluation of compliance with State regulatory requirements into its own survey process; or (iii) Demonstrating that its existing survey process adequately evaluates compliance with State regulations; and (d) On request, provide to OHCQ a copy of: (i) A complaint investigation; (ii) Surveyor qualifications; (iii) A change in a laboratory's disciplines, subdisciplines, or specialties; and (iv) Other information the Secretary may require relating to approval of a laboratory accrediting organization. #### Regulation .03 Surveys. *COMAR 10.10.02.03* A. General. (1) A licensee shall allow an on-site survey by the OHCQ or, when applicable, by the laboratory's approved accrediting organization, at any time during the laboratory's normal hours of operation, to evaluate the laboratory's compliance with the applicable requirements, conditions, and standards of this subtitle. (2) A survey may include but is not limited to: (a) Observation and examination of laboratory facilities; (b) Equipment; (c) Quality assurance and quality control program records; (d) Operating procedures; (e) Personnel; (f) Personnel records; (g) Proficiency testing; (h) Patient reports; and (i) Other records and files pertinent to this subtitle. (3) Laboratory employees shall make data and records accessible within a reasonable time during the on-site survey. B. Excepted Laboratory. A licensee operating a laboratory under a letter of exception, other than a mobile or temporary laboratory, is: (1) Not subject to routine, on-site surveys; (2) Subject to surveys resulting from complaints or periodic validations, or both, conducted by the Secretary or CMS, or both, to determine regulatory compliance; and (3) Required to make available, pursuant to a survey, records the Secretary may reasonably require to determine regulatory compliance. C. Permitted Laboratory. A licensee operating a laboratory under a permit shall: (1) Be subject to routine surveys conducted by OHCQ; (2) Undergo a routine annual survey for 2 consecutive years after the laboratory: (a) Begins operating; (b) Undergoes a change in ownership; (c) Fails to complete or submit to the Department an acceptable quality assurance self-assessment on forms provided by the OHCQ; or (d) Has imposed on it a principal or alternative sanction; and (3) Undergo a routine biennial survey when the laboratory: (a) Does not fall under one of the categories set forth in §C(2) of this regulation; and (b) Completes and submits to the OHCQ an acceptable quality assurance self-assessment on forms provided by the OHCQ on the years when the OHCQ does not conduct an on-site survey, except as provided in §D of this regulation. D. Accredited Laboratory. An accredited laboratory: (1) Undergoing routine on-site surveys conducted by an accrediting organization approved by the Secretary, except as provided in §D(2) and (3) of this regulation, is not subject to routine surveys conducted by the OHCQ; (2) Is subject to surveys conducted by the OHCQ to investigate a complaint or to determine regulatory compliance; and (3) Holding a permit in the discipline of forensic toxicology, subdiscipline of job-related testing, is subject to routine surveys of the laboratory's alcohol and controlled dangerous substances testing areas conducted by the OHCQ. E. Temporary or Mobile Laboratory. The OHCQ may survey each testing event site when a temporary or mobile laboratory licensee offers to perform or performs testing services. F. Excepted Laboratory — Limited Testing for Rare Diseases. A licensee operating a laboratory under a letter of exception — limited testing for rare diseases is subject to the survey requirements stated in §B of this regulation. ### Chapter 03 — Medical Laboratories — Licenses **Authority:** Environment Article, §6-303; Health-General Article, §§2-104(b), 17-202, 17-205—17-210, 17-212, 17-502, 17-503, 17-505, and 17-510; Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); July 23, 2001 (28:14 Md. R. 1321) **Administrative History:** Regulation .01A amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .01E adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787); April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .02B amended as an emergency provision effective November 1, 2004 (31:25 Md. R. 1789); amended permanently effective January 6, 2005 (31:26 Md. R. 1863); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .02B amended effective August 29, 2005 (32:17 Md. R. 1438); February 22, 2010 (37:4 Md. R. 341); April 16, 2012 (39:7 Md. R. 492); November 12, 2012 (39:22 Md. R. 1428); April 1, 2013 (40:6 Md. R. 473); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .02C amended effective November 12, 2012 (39:22 Md. R. 1428) **Administrative History:** Regulation .03C amended effective June 1, 2009 (36:11 Md. R. 787); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B, E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .05 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06A amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 General. *COMAR 10.10.03.01* A. Requirement. (1) General. A person shall possess a license before: (a) Offering to perform or performing a medical laboratory test or examination in this State; (b) Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; or (c) Representing or servicing in this State a laboratory regardless of the laboratory's location. (2) Prohibited Tests. The Secretary may impose principal and alternative sanctions as set forth in COMAR 10.10.08.01A if a person offers to perform or performs a test or part of a test, including the use of a reagent, supply, procedure, technique, kit, or equipment, that: (a) Does not produce accurate or reliable results as evidenced by documented, independent scientific testing and evaluation; or (b) Lacks proof of efficacy substantiated by an independently conducted and documented scientifically based clinical trial. (3) Cholesterol Testing Plan for Health Departments. (a) A local or county health department intending to perform cholesterol testing outside a permanently located laboratory may submit to the Secretary a cholesterol testing plan instead of applying for a cholesterol testing permit. (b) If the submitted plan meets applicable standards under this chapter, the Secretary may waive the permit requirement for a cholesterol testing permit. (c) If the plan does not meet the applicable standards of this chapter, the local or county health department shall apply for a permit as set forth in this chapter. B. Limitation. A person may not operate a laboratory in a discipline other than what is listed on the license. C. Eligibility. A person meeting the requirements and standards of this chapter may apply for one or more of the following licenses: D. Issuance. (1) Provisional Permit. (a) The Secretary may issue a provisional permit before or after conducting an initial survey and pending determination of compliance with the standards in this chapter. (b) A provisional permit is valid for not more than 180 days and may not be renewed. (2) Letter of Exception and Permit. The Secretary may issue a letter of exception or permit that: (a) Is valid for not more than 2 years from the date of issue; and (b) Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period. (3) Single-Site and Multi-Site Licenses. (a) Except as set forth in §D(3)(b) of this regulation, a person shall obtain a separate, single-site license for each location at which a laboratory performs a test. (b) The Secretary may issue a multi-site license to a person operating: (i) A mobile laboratory using the address of its home base or main administrative office in the State; (ii) A nonprofit laboratory or public health laboratory performing limited public health testing; and (iii) Hospital laboratories located at the same street address or within contiguous buildings and under common direction. E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local laboratory requirements. #### Regulation .02 Letters of Exception. *COMAR 10.10.03.02* 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 CLIA waived tests. 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. #### Regulation .03 Permits. *COMAR 10.10.03.03* A. Requirement. A person operating a medical laboratory that performs one or more tests other than excepted tests shall obtain and renew a laboratory permit as required in this chapter. B. Tests Other than Excepted Tests. (1) A test other than an excepted test is one not listed in Regulation .02B of this chapter. (2) A person holding a permit may perform both excepted tests and tests other than excepted tests. C. Regulatory Requirements. A person operating a medical laboratory under a permit shall: (1) Obtain, complete, and submit permit applications as prescribed in this chapter and COMAR 10.10.04; (2) Comply with the survey requirements set forth in this subtitle; (3) Comply with the applicable quality assurance and quality control requirements required in COMAR 10.10.06; (4) Comply with the applicable proficiency testing requirements required in COMAR 10.10.05; and (5) Comply with the applicable personnel requirements required in COMAR 10.10.06.15B and 10.10.07. #### Regulation .04 Letter of Exception and Permit — Administrative Procedures. *COMAR 10.10.03.04* A. Application — Filing. (1) Except for a laboratory eligible for a multi-site license as set forth in Regulation .01D(3)(b) of this chapter, a person shall apply for a license for each laboratory location. (2) A person holding a license to operate a laboratory in the discipline of chemistry or health awareness testing is not required to obtain a separate cholesterol testing permit to conduct cholesterol testing at a temporary laboratory site if the licensee complies with the requirements applicable to a temporary laboratory as set forth in this subtitle. (3) A person shall complete and file an application for a license using forms provided by the OHCQ. (4) A person shall complete on the application a description of laboratory services, which includes but is not limited to: (a) Types of tests performed or to be performed; (b) Total number of tests performed or to be performed annually, excluding tests for quality control and proficiency testing; and (c) Qualifications of personnel who direct, supervise, and perform laboratory testing. (5) The laboratory director shall sign the application forms attesting that the information provided is accurate and that the laboratory is or will be operated in accordance with the requirements and standards required in this chapter. B. Application — Evaluation and Billing. (1) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if an application is complete. (2) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the laboratory is eligible for a: (a) Letter of exception; (b) Letter of exception — limited testing for rare diseases; or (c) Permit. C. Application — Denial of License. If the OHCQ determines that a laboratory is not in compliance with the requirements of this chapter and therefore cannot be issued a license, the OHCQ shall provide to the laboratory: (1) A written statement of the grounds on which the denial is based; and (2) The opportunity to: (a) Amend and resubmit the application; or (b) Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201—10-226, and Health-General Article, §§17-210 and 17-509, Annotated Code of Maryland. D. Notification Requirements. A licensee shall notify the OHCQ within 30 days of a change in laboratory: (1) Ownership; (2) Name; (3) Location; or (4) Director. E. Amending a Permit. Except as prescribed in §D of this regulation, a licensee holding an unexpired permit who wishes to amend it shall: (1) Submit a written request for amendment to the Secretary; and (2) Obtain written approval from the OHCQ before implementing the amendment. F. Non-Transferability. A license is not transferable between laboratories, directors, or locations. G. Letter of Exception. A person applying for a letter of exception for a POL or POCL shall submit an initial application. H. Letter of Exception — Limited Testing for Rare Diseases. A person applying for a letter of exception—limited testing for rare diseases for a laboratory shall submit an initial application. #### Regulation .05 Letter of Exception — Limited Testing for Rare Diseases. *COMAR 10.10.03.05* A. The Secretary may waive the permit requirements under this subtitle for a laboratory that offers to perform or performs a rare disease test if the laboratory: (1) Meets the requirements of Regulations .05 and .06 of this chapter; and (2) Obtains and maintains a letter of exception — limited testing for rare diseases. B. Eligibility. A person operating a medical laboratory may be eligible for a letter of exception — limited testing for rare diseases if the laboratory: (1) Is operated as: (a) A not-for-profit entity; or (b) Part of an accredited educational institution; (2) Performs not more than a total of 50 tests per year for a specific rare disease on specimens from Maryland patients; (3) Offers to perform or performs only rare disease tests as defined in COMAR 10.10.01.03B; (4) Possesses a valid CLIA certificate for the complexity of the testing performed; (5) Does not possess a Maryland permit for offering to perform or performing medical laboratory testing; and (6) Meets the requirements for a laboratory to operate under a letter of exception — limited testing for rare diseases. C. Research Laboratory. A research laboratory may obtain a letter of exception — limited testing for rare diseases if the laboratory meets the eligibility requirements of §B of this regulation. #### Regulation .06 Letter of Exception — Limited Testing for Rare Diseases; Standards and Requirements. *COMAR 10.10.03.06* A. Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception — limited testing for rare diseases shall: (1) Submit: (a) A completed: (i) Application as prescribed in Regulation .04 of this chapter; and (ii) Report or questionnaire as required by the Secretary to determine regulatory compliance; (b) A copy of the laboratory's: (i) Current CLIA certificate issued by CMS; and (ii) Most recent CLIA survey report; (c) Documentation of the rare disease testing offered or performed, including but not limited to: (i) The test procedure, including instructions for quality control and quality assurance; (ii) A description of the disease or condition; (iii) An explanation of the clinical validity of the test; (iv) The performance characteristics of the test; (v) The expected turnaround time for patient test results; and (vi) Additional information necessary for determining eligibility and compliance with this subtitle; and (2) Agree to: (a) Make records and reports available to the Department as the Secretary may require; (b) Notify the Department when a change to a licensee's rare disease testing procedure occurs for the purpose of the Department's determining whether the change is in compliance with this subtitle; (c) Perform not more than 50 rare disease tests each year on specimens from Maryland patients; and (d) Submit to the Department statistics that detail the number and types of rare disease tests performed each year on specimens from Maryland patients. B. Standards. A person that wishes to obtain and maintain a letter of exception — limited testing for rare diseases shall: (1) Comply with good laboratory practices that include: (a) Following the manufacturer's instructions for instrument or test system operation and test performance; (b) Having and following a written procedure manual describing the processes for performing tests and reporting patient test results; (c) Performing applicable instrument calibration procedures at least once every 6 months; (d) Performing and documenting quality control procedures using applicable levels of control materials each day of testing; and (e) Performing and documenting that remedial action has been taken when problems or errors are identified; and (2) Meet the requirements and standards in this subtitle applicable to a permitted laboratory including: (a) Proficiency testing under COMAR 10.10.05; (b) Quality assurance under COMAR 10.10.06; (c) Personnel under COMAR 10.10.07; (d) Sanctions under COMAR 10.10.08; and (e) CLIA regulations incorporated by reference at COMAR 10.10.01.04B(3) — (5). C. If the submitted application and explanatory documentation do not meet the requirements of this regulation or if the information submitted for the plan is insufficient to make a determination of compliance with this subtitle, a person may: (1) Submit amendments to the application and explanatory documentation; or (2) Apply for a permit in accordance with this subtitle. D. The OHCQ may conduct on-site surveys of a laboratory operating under a letter of exception — limited testing for rare diseases to: (1) Investigate a complaint; or (2) Determine compliance with this subtitle. E. If a licensee wishes to perform more than 50 rare disease tests per year, the licensee shall submit an application for and obtain a permit as required under this subtitle. ### Chapter 04 — Medical Laboratories **Authority:** Health-General Article, §§17-202, 17-204, 17-205, 17-207, 17-209, 17-502, 17-503, and 17-506, Annotated Code of Maryland **Administrative History:** Effective date: February 19, 1990 (17:3 Md. R. 297) **Administrative History:** Regulation .01 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .03B amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .05 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .06 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .07 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .08E amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .09 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .12B and C amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulations .01—.12 repealed and new Regulations .01—.19 adopted effective February 26, 1996 (23:4 Md. R. 273) **Administrative History:** Chapter, Cholesterol Testing, repealed and new chapter, Medical Laboratories — Fees, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02 amended effective July 23, 2001 (28:14 Md. R. 1321); June 1, 2009 (36:11 Md. R. 787); August 19, 2013 (40:16 Md. R. 1344); December 21, 2015 (42:25 Md. R. 1543) **Administrative History:** Regulation .03A amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Chapter, Medical Laboratories — Fees renamed Medical Laboratories effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .01E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .02 amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Chapter repealed effective March 1, 2026 (52:24 Md. R. 1198) ### Chapter 05 — Medical Laboratories — Proficiency Testing **Authority:** Health-General Article, §§17-202 and 17-211, Annotated Code of Maryland **Administrative History:** Effective date: October 5, 1998 (25:20 Md. R. 1529) **Administrative History:** Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories — Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04D amended effective November 29, 2010 (37:24 Md. R. 1658) **Administrative History:** Regulation .05A, B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .05B, C amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05C amended effective November 29, 2010 (37:24 Md. R. 1658) #### Regulation .01 Participation and Evaluation. *COMAR 10.10.05.01* A. Participation. A licensee operating under a permit shall ensure that the laboratory: (1) Enrolls in and participates satisfactorily in a PT program that meets the criteria set forth in this chapter for each of the tests that the laboratory offers to perform or performs; (2) Tests PT samples in the same manner and number of times that it routinely tests patient specimens; and (3) Complies with the applicable standards contained in 42 CFR §§493.801—493.807. B. Evaluation — General. When a PT program does not evaluate a participating laboratory's PT results or the evaluated PT results are inconsistent with satisfactory performance, the participating laboratory and the OHCQ shall evaluate the PT results by comparing them to the all-method-results mean, all-instrument-results mean, or the all-participant-results mean found in the PT program's summaries of PT results. C. Evaluation — Departmental. (1) Administrative Procedures. (a) Submission of Results. The OHCQ shall monitor for regulatory purposes only official results sent directly from the PT program. (b) Multiple Programs. If a licensee enrolls in more than one PT program and duplicate testing and reporting occurs, the licensee shall notify the OHCQ which PT program is to be scored for regulatory purposes. (c) Sample Testing. A licensee shall operate under the following PT procedures: (i) PT samples shall be tested each time a shipment is received and for only those procedures offered or allowed under a laboratory's license; (ii) If a test is no longer offered or performed, the licensee shall inform the OHCQ in writing; (iii) PT samples shall be tested only in the laboratory for which they are intended; (iv) PT samples shall be handled, processed, and tested in the same manner as patient specimens; and (v) Repeat testing may not be performed on PT samples unless it is the laboratory's policy to test patients in duplicate or if abnormal test results are routinely repeated to verify accuracy. (d) Testing and Reporting Deadlines. (i) A licensee shall test PT samples and report PT results within the time limits set by the PT program. (ii) PT results submitted late by a licensee are deemed unsatisfactory by the PT program and the OHCQ. (e) PT Program Evaluation Errors. A licensee is responsible for seeing that an evaluation error on the PT report is corrected by the PT program and that the program sends a corrected PT report to the OHCQ. (f) Performance Records. A laboratory's marginal or unsatisfactory PT performance may not be changed to reflect satisfactory performance when: (i) PT results are not submitted; (ii) PT results are submitted after the due date; or (iii) Transcription errors involving PT results went unnoticed until the evaluated results were scored. (2) Evaluation Procedures. (a) Grading Criteria. (i) The PT program shall score test results in terms of correlation with reference or referee laboratory test results, target values, or statistical methods based on means and standard deviations. (ii) The OHCQ shall determine a laboratory's PT performance based on a PT program's numerical score for each specialty, subspecialty, constituent, analyte, and culture type. (b) Scores. Numerical PT scores required for satisfactory performance in each subdiscipline, specialty or subspecialty are as follows: (i) AFP for NTD, equal to or greater than 80 percent; (ii) Antibodies for HIV, equal to or greater than 80 percent; (iii) Bacteriology, equal to or greater than 80 percent; (iv) Blood gases, equal to or greater than 80 percent; (v) Blood lead, equal to or greater than 80 percent; (vi) Chemistry, equal to or greater than 80 percent; (vii) Coagulation, equal to or greater than 80 percent; (viii) Cytogenetics, as set by PT program; (ix) Drugs of abuse, forensic, equal to or greater than 90 percent; (x) Drugs of abuse, clinical or diagnostic, equal to or greater than 80 percent; (xi) Hematology, equal to or greater than 80 percent; (xii) Immunohematology, ABO and Rh typing, antibody screen, 100 percent; (xiii) Immunohematology, antibody identification, equal to or greater than 90 percent; (xiv) Mycology, equal to or greater than 80 percent; (xv) Mycobacteriology, equal to or greater than 80 percent; (xvi) Immunology, nonsyphilis serology, equal to or greater than 80 percent; (xvii) Parasitology, equal to or greater than 80 percent; (xviii) Syphilis serology, equal to or greater than 80 percent; and (xix) Urinalysis, equal to or greater than 80 percent. (c) Scoring Criteria. A percent score is derived by dividing the number of satisfactory PT results by the total number of PT results for each subdiscipline, specialty, subspecialty, or individual constituent or analyte within a subspecialty. (d) PT Failure. PT scores lower than the percent scores listed in §C(2)(b) of this regulation are failing scores. (e) Evaluated PT Results. PT results evaluated in determining PT performance include PT results not evaluated by the PT program, code 10 results, for example, 10E, 10G, 10T, and codes of tests not performed. (3) Initial or Single PT Failure. (a) Licensee Action. A licensee shall investigate a single or initial PT failure and document the corrective action taken. (b) Departmental Procedures. The OHCQ shall document an initial or single PT failure and may request a licensee to submit a plan of correction and supporting documentation related to the failure. (4) Marginal PT Performance. (a) Test Scores. PT performance is marginal when a laboratory exhibits failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol. (b) Departmental Procedures. The OHCQ shall: (i) Document the marginal PT; (ii) Send written notice of the marginal PT to the licensee; and (iii) Request the licensee to submit a written plan of correction. (c) Laboratory Actions. A licensee shall submit to the OHCQ a written plan of correction that describes the investigation and steps taken to improve the applicable test performance. (5) Unsatisfactory PT Performance. PT performance is unsatisfactory when a laboratory exhibits: (a) Failing PT scores in three of four consecutive testing events in a subdiscipline, specialty, or individual constituent or analyte, for example, Na, RBC, cholesterol; (b) Failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol, and the next PT report for the test states “test not performed”; or (c) An average PT score for a test over the last four consecutive testing events that falls below the minimum percent score set forth in §C(2)(b) of this regulation. #### Regulation .02 Discipline, Specialty, and Subspecialty. *COMAR 10.10.05.02* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory participates successfully in PT, when applicable, for each test or analyte in each of the following disciplines, subdisciplines, and specialties: (1) Microbiology, including the subdisciplines of: (a) Bacteriology; (b) Mycobacteriology; (c) Mycology; (d) Parasitology; and (e) Virology; (2) Immunology, including the subdisciplines of: (a) General immunology; (b) General serology; and (c) Syphilis serology; (3) Chemistry, including the subdisciplines of: (a) Blood gas analysis; (b) Endocrinology; (c) Routine chemistry; and (d) Toxicology; (4) Genetics, including the subdisciplines of: (a) Biochemical genetics; (b) Cytogenetics; and (c) Molecular genetics; (5) Hematology, including the subdisciplines of: (a) Coagulation testing; and (b) Routine hematology; (6) Pathology, including the subdiscipline of gynecologic cytology; (7) Immunohematology, including the specialties of: (a) ABO group and D(Rho) typing; (b) Unexpected antibody detection, that is, antibody screen; (c) Antibody identification; and (d) Compatibility testing; and (8) Forensic toxicology limited to job-related alcohol and controlled dangerous substances. B. Discipline Standards. (1) General. A licensee operating under a permit shall ensure that the laboratory meets the applicable PT standards set forth in this chapter and in 42 CFR §§493.821493.865. (2) Gynecologic Cytology. A licensee operating under a permit to perform gynecologic cytology shall ensure that the laboratory enrolls and maintains successful participation in a cytology PT program approved by CMS. (3) Job-Related Testing. (a) A licensee operating under a permit to perform job-related testing for alcohol or controlled dangerous substances shall ensure that the laboratory enrolls and continues to participate satisfactorily, when applicable, in one or more of the programs listed in §B(3)(b)(e) of this regulation. (b) Screening Tests. A licensee operating under a permit to perform screening tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The American Association of Bioanalysts (AAB) Urine Toxicology Screening survey; (ii) The American Association for Clinical Chemistry/College of American Pathologists (AACC/CAP) Forensic Urine Drug Testing Screening survey; or (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (c) Confirmation Tests. A licensee operating under a permit to perform confirmation tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The AACC/CAP Forensic Urine Drug Testing Confirmatory survey; (ii) The federal Substance Abuse and Mental Health Services Administration's Federal Workplace Drug Testing Program; or (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (d) Blood Alcohol Tests. A licensee operating under a permit to perform tests for alcohol in blood shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The AACC/CAP survey for whole blood alcohol or serum alcohol, or both; or (ii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (e) Hair Analysis. A licensee operating under a permit to perform tests for a controlled dangerous substance in hair shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The State of Florida's P.T. program for drug testing in hair; or (ii) Another program that possesses standards set by the Secretary or that are equivalent to the State of Florida's PT program for drug testing in hair and is approved by the Secretary as set forth in Regulation .03 of this chapter. #### Regulation .03 Program Approval. *COMAR 10.10.05.03* A. Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a PT program in this State without first obtaining program approval from CMS or the OHCQ. B. Approval Granted Automatically. Except in the discipline of job-related alcohol and controlled dangerous substances, or other disciplines, subdisciplines, or specialties not covered by federal PT requirements, a PT program is approved when it is based on written evidence issued by CMS showing the program meets CMS's criteria for approval of PT programs as set forth in 42 CFR §§493.901—493.959. C. Approval Granted by the Secretary. The OHCQ may approve a PT program for a laboratory discipline, subdiscipline, or specialty not approved by CMS, if the program: (1) Provides reliable, documented evidence that the program is technically and administratively able to meet the applicable requirements of this chapter; and (2) Uniformly and routinely prepares and submits directly to the OHCQ evaluations of all PT results from all laboratories enrolled in the program and holding a Maryland permit. #### Regulation .04 Cytology — Departmental Requirements. *COMAR 10.10.05.04* A. The Secretary may not issue a license to operate a laboratory that examines gynecologic cytology specimens if the laboratory does not enroll and participate satisfactorily in a cytology PT program approved by CMS. B. The OHCQ shall evaluate an individual's PT performance as set forth in 42 CFR §493.945. #### Regulation .05 Cytology — Laboratory and Individual Standards. *COMAR 10.10.05.05* A. Primary Standard. A pathologist or cytotechnologist who examines gynecological cytology specimens from individuals in this State shall participate satisfactorily in an annual cytology PT program approved by CMS. B. Laboratory Standards. (1) A licensee operating under a permit to examine gynecologic cytology specimens shall ensure that each pathologist and cytotechnologist who examines gynecologic cytology specimens participates in a cytology PT program conducted by the Department or approved by CMS. (2) A licensee employing an individual who has failed a second testing event in an annual PT cycle shall: (a) Prohibit the individual from examining gynecologic specimens and provide or secure remedial training and education in gynecologic cytology for the individual, which training and education includes examination by the individual of gynecologic specimens in the individual's area of failure; and (b) Document the individual's completion of education and training. (3) A licensee employing an individual who has failed a first or subsequent PT event and who does not obtain mandated retesting or retraining, or both, shall: (a) Immediately remove that individual from a position of examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider; and (b) Provide written notice to the OHCQ within 30 days after being informed of the individual's last test failure that the individual is no longer examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider. C. Individual Standards. (1) A cytotechnologist or pathologist who examines gynecological cytology specimens shall participate in an annual PT event that involves the examination of a 10-slide or 20-slide test set as set forth in 42 CFR §493.945. (2) An individual passes a testing event and performs satisfactorily in PT when the individual scores at least 90 percent on a 10-slide or 20-slide test set. (3) An individual fails a testing event and performs unsatisfactorily in PT if the individual: (a) Scores less than 90 percent on a 10-slide or 20-slide test set; or (b) Fails to take a scheduled retest without prior Department approval. (4) An individual who fails the annual testing event shall take a second test with another 10-slide test set: (a) Within 45 days after receiving notice of a test failure; or (b) At a later date with prior Department approval. (5) An individual who fails a second test shall: (a) Cease examining gynecologic specimens immediately upon being notified of the second failure; (b) Complete at least 40 hours of remedial training and education in gynecologic cytology that includes examining gynecological specimens in the area of failure; (c) Complete the required training and education in a laboratory that operates under a: (i) State permit for in-State laboratories; or (ii) Certificate issued by CMS in the subdiscipline of gynecologic cytology for out-of-State laboratories; (d) Document the required remedial training and education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ; (e) Schedule and take a third test with a 20-slide test set within 30 days of completing the required remedial training and education; and (f) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the third test. (6) An individual who fails a third or subsequent test shall: (a) Complete at least 35 hours of documented, formally structured, continuing education in diagnostic cytopathology that focuses on the examination of gynecologic preparations; (b) Document the education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ; (c) Schedule and take a subsequent test with a 20-slide test set within 30 days of completing the required continuing education; and (d) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the test required under §C(6)(c) of this regulation. (7) An individual who fails a first or subsequent testing event in an annual PT cycle and who chooses not to complete mandatory retesting or remedial training, or both, shall: (a) Immediately cease examining gynecologic cytology specimens and notify the OHCQ of this in writing; and (b) Reenter the PT process at the point where the individual previously chose to withdraw from the testing process, if the individual decides at a later date to satisfy PT requirements. ### Chapter 06 — Medical Laboratories — Quality Assurance **Authority:** Health-General Article, §§17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland **Administrative History:** Effective date: November 18, 1985 (12:23 Md. R. 2217) **Administrative History:** Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulations .01—.28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .09B amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .25 amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Chapter, Physician Office and Other Point-of-Care Laboratories, repealed and new chapter, Medical Laboratories—Quality Assurance, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .02C amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03B amended effective July 24, 2000 (27:14 Md. R. 1340); January 13, 2011 (38:1 Md. R. 11) **Administrative History:** Regulation .04B adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .05 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05-1 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06 repealed effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .08 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .08B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .09 repealed effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .10 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .10B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .12 amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .12B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .13B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .14B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .15 amended effective June 1, 2009 (36:11 Md. R. 787); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .15B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .16 repealed effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .16A amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 General. *COMAR 10.10.06.01* A. Primary Standards. To obtain or maintain a permit to operate a laboratory, a person or licensee shall ensure that the laboratory: (1) Establishes and follows written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total, that is, preanalytic, analytic, and postanalytic phases of the testing process; (2) Maintains a quality assurance program that: (a) Continually evaluates the effectiveness of the laboratory's policies and procedures; (b) Routinely revises policies and procedures based on the results of on-going evaluation; (c) Identifies and corrects problems; (d) Assures accurate, reliable, and prompt reporting of test results; (e) Assures adequate and competent personnel; and (f) Documents all quality assurance activities; and (3) Establishes and maintains a laboratory safety program. B. Standards. A licensee shall ensure that the laboratory: (1) Meets the applicable: (a) Quality assurance standards set forth in this chapter and in 42 CFR §§493.1230 — 493.1299; and (b) Quality testing standards for facility administration set forth in this chapter and in 42 CFR §§493.1100 — 493.1101; (2) Establishes, maintains, and enforces a laboratory safety program that: (a) Provides all personnel with access to a safety manual covering the following topics, when applicable: (i) General personnel safety; (ii) Fire prevention and control; (iii) Biological hazards; (iv) Chemical hazards; (v) Radiological hazards; (vi) Special medical waste disposal; and (vii) The reporting of incidents and accidents; and (b) Complies with the following applicable federal Occupational Safety and Health Administration standards: (i) “Occupational Exposure to Hazardous Chemicals in Laboratories”, contained in 29 CFR §1910.1450; and (ii) “Bloodborne Pathogens,” contained in 29 CFR §1910.1030; and (3) Maintains a collection station: (a) As part of and under the direction of the laboratory for which it collects specimens; and (b) With equipment and staff appropriate for the collection, preservation, storage, and maintenance of specimens in a manner suitable for later examination. #### Regulation .02 Authorization to Request Laboratory Tests. *COMAR 10.10.06.02* A. Primary Standard. A laboratory may not perform a laboratory test, except under a health awareness permit or cholesterol permit, without obtaining written or electronic authorization from: (1) A court of law; (2) A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or (3) Another person authorized to order laboratory tests under the Annotated Code of Maryland. B. Other Authorized Persons. Other persons authorized to order laboratory tests include: (1) A nurse midwife certified by the Maryland State Board of Nursing under COMAR 10.27.05; (2) A nurse practitioner certified by the Maryland State Board of Nursing under COMAR 10.27.07; (3) A physician's assistant, as authorized by the physician's assistant's supervising physician; (4) A chiropractor requesting a test on blood or urine; (5) An employer requesting a job-related test for alcohol or controlled dangerous substances; (6) Clinical staff who: (a) Meets the qualifications set forth in COMAR 10.47.01.06D; (b) Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and (c) Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program; (7) A pharmacist, for tests that qualify for a letter of exception under COMAR 10.10.03.02B and for glucose, A1c, lipids (including total cholesterol, HDL, LDL, and triglycerides), AST, and ALT; and (8) A naturopathic physician consistent with Health Occupations Article, §14–5F–01 through §14–5F–32, Annotated Code of Maryland and COMAR 10.32.21. C. Standards. A licensee shall ensure that the laboratory meets the applicable standards concerning test requisition contained in 42 CFR §493.1241. #### Regulation .03 Patient Test Management. *COMAR 10.10.06.03* A. Primary Standard. A licensee shall ensure that the laboratory: (1) Provides patient manipulation by qualified personnel; and (2) Employs and maintains a quality assurance program that provides for: (a) Proper patient preparation; (b) Proper specimen: (i) Collection; (ii) Identification; (iii) Preservation; (iv) Transportation; and (v) Processing; (c) Record maintenance; and (d) Accurate reporting of results. B. Standard — Patient Manipulation and Specimen Collection. (1) A person may not manipulate a patient, for example, to collect specimens unless the person is: (a) A licensed: (i) Physician; or (ii) Nurse; (b) Authorized by law to: (i) Collect a specimen from an individual for medical laboratory testing; or (ii) Manipulate a patient; or (c) Employed by a licensee under this title. (2) A licensee shall ensure that specimens for laboratory testing are collected by individuals who are trained in and have documented experience in: (a) Preparing patients for specimen collection; and (b) Collecting the appropriate specimen required for the requested test. (3) Qualified personnel authorized by the licensee may collect: (a) Blood specimens, including: (i) Venipuncture; and (ii) Finger or heel stick whole-blood specimens; (b) Stomach contents; and (c) Clinical materials for smears and culture, for example, throat and nasopharyngeal swabs, and other specimens required to perform a requested test under the direction or on the written request of a physician or other person authorized by law and identified in Regulation .02 of this chapter. (4) An employer may collect a specimen for job-related testing to determine use or abuse of a controlled dangerous substance or alcohol as set forth under COMAR 10.10.10. (5) A person collecting specimens for medical laboratory testing or examination shall follow the licensee's policies and procedures contained in the laboratory's quality assurance system as set forth in §C of this regulation. (6) This section does not apply to the collection of a DNA specimen with a buccal swab used for determining paternity. C. Standard — Quality Assurance. A licensee shall ensure that the laboratory's quality assurance system: (1) Provides optimum patient test results by establishing and maintaining mechanisms to preserve specimen integrity and maintain positive specimen identification throughout the entire testing process, including the: (a) Preanalytic phase; (b) Analytic phase; and (c) Postanalytic phase; and (2) Meets the applicable standards contained in 42 CFR §§493.1230 — 493.1234, 493.1240 — 493.1249, and 493.1281—493.1299. #### Regulation .04 Reporting and Releasing Test Results. *COMAR 10.10.06.04* 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. #### Regulation .05 Quality Control — General. *COMAR 10.10.06.05* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written quality control procedures for monitoring and evaluating the quality of the analytic phase of the testing process for each testing method and procedure to assure the accuracy and reliability of patient test results and reports. B. Standard. A licensee shall ensure that the laboratory meets the applicable quality control standards as set forth in this chapter and in 42 CFR §§493.1200—493.1299. #### Regulation .05-1 Quality Control — Quality Control Program. *COMAR 10.10.06.05-1* A. Primary Standard. A licensee shall develop, establish, implement, maintain, and follow quality control policies, procedures, and techniques that ensure accurate and reliable test results and patient test reports. B. Standard — Quality Control Program. A licensee's quality control program shall: (1) Cover all tests and related examinations and procedures performed by the laboratory; and (2) Meet the standards and requirements set forth in this chapter. C. Standard — Quality Control Practices. A licensee's quality control practices shall include, but are not limited to, the use of: (1) Analyses of reference materials to ensure that test results are: (a) Reproducible; (b) Accurate; and (c) Reliable; (2) Systems to ensure proper functioning of: (a) Instruments; (b) Equipment; and (c) Reagents; (3) Validity, calibration, and systematic procedural checks for: (a) Reagents; (b) Equipment; and (c) Test systems; and (4) Systems for: (a) Review and reporting of test results that ensure timely error detection and correction; and (b) Assessment of laboratory personnel: (i) Performance; (ii) Proficiency; and (iii) Competency. D. Standard — Adequacy of Methods and Equipment. A licensee shall: (1) Employ methods and equipment that provide accurate and reliable test results and reports; (2) Have sufficient and suitable equipment and instruments to perform the type of testing services and volume of tests offered by the laboratory; (3) Monitor all test methods, instruments, and test systems for the following performance characteristics, when applicable: (a) Detection limits for each: (i) Method; (ii) Instrument; and (iii) Test system; (b) Precision; (c) Accuracy; (d) Specificity; (e) Sensitivity; (f) Test interferences; and (g) Other related test variables that affect test results; (4) Have adequate systems in place to: (a) Ensure that a statistically valid number of counts or measurement levels are obtained and verified to give accurate and reliable test results for systems each day instruments and equipment such as cell counters, radiation counters, and spectrophotometers are used; and (b) Report results in an accurate and reliable manner and within the time frames established by the laboratory; and (5) Perform test methods and use instrumentation in a manner that permits the laboratory to provide accurate and reliable test results within the laboratory's stated performance criteria. E. Standard — Supplies, Reagents, and Materials. A licensee shall ensure that supplies, reagents, and other materials used in the collection, handling, testing, and storing of specimens in the laboratory are stored, labeled, checked for proper reactivity, and used according to §§F — I of this regulation. F. Storage. A licensee shall ensure that laboratory materials are stored in the manner stated by the manufacturer. G. Labeling. A licensee shall ensure that laboratory testing materials, including reagents, solutions, culture media, controls, and calibrators are labeled to indicate the: (1) Identity; (2) Concentration, strength, or titer; (3) Storage requirements; (4) Preparation and expiration dates; (5) Identity of the preparer; and (6) Other pertinent information that would affect test performance or outcome. H. Reactivity Checks. A licensee shall ensure that representative samples of each lot of materials used for or in the process of testing specimens are tested on a regularly scheduled basis to determine each material's capacity to perform as required. I. Use of Supplies and Other Materials. A licensee: (1) May not use materials that have: (a) Exceeded the material's expiration date; (b) Substandard reactivity; or (c) Deteriorated; and (2) Shall use supplies, reagents, kits, identification systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer. #### Regulation .06 Quality Control — Single-Use Test Devices. — Repealed. *COMAR 10.10.06.06* #### Regulation .07 Quality Control — Specialty and Subspecialty. *COMAR 10.10.06.07* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written policies and procedures for a comprehensive quality control program that includes verification and assessment of accuracy, measurement of precision, and detection of error for all analyses and procedures performed by the laboratory. B. Standards. (1) General. A licensee shall ensure that the laboratory meets the applicable quality control requirements for each specialty and subspecialty under: (a) 42 CFR §§493.1200—493.1299; and (b) Regulations .07—.15 of this chapter. (2) Cholesterol. A licensee or approved plan holder of a laboratory that performs cholesterol tests shall ensure that the laboratory obtains and maintains control samples at two levels, near or bracketing the 200 and 240 micrograms/deciliter decision levels. #### Regulation .08 Quality Control — Job-Related Alcohol and Drug Testing. *COMAR 10.10.06.08* A. Primary Standard. A licensee shall ensure that a laboratory has in place a quality assurance program designed to monitor and evaluate all phases of the testing process including but not limited to: (1) Laboratory certification; (2) Specimens, specimen collection, chain of custody, and transport; (3) Security and controlled access; (4) Storage and specimen retention; (5) Analytical methods and procedures; (6) Accuracy, precision, and reliability; (7) Reporting test results; and (8) Proficiency testing. B. Standards. (1) Certification. A licensee of a laboratory that offers to perform or performs screening or confirmation tests for alcohol or controlled dangerous substances shall ensure that the laboratory is inspected and certified to perform tests for alcohol or controlled dangerous substances by: (a) The Secretary; (b) The College of American Pathologists; (c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or (d) A government agency, program, or accrediting organization approved by the Secretary as set forth in COMAR 10.10.02.02. (2) Specimens, Specimen Collection, Chain of Custody, and Transport. (a) Permissible Specimens. A licensee shall ensure that job-related tests for alcohol or controlled dangerous substances are only performed using specimens derived from the human body as set forth in COMAR 10.10.10.06. (b) A licensee shall ensure that a specimen is processed, handled, and transported in a manner that protects the identity and physical integrity of the specimen by: (i) Accepting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; and (ii) Implementing, maintaining, and employing chain of custody procedures, including documentation of specimen handling and access, that cover the life of a specimen from the time of collection through final disposal of the specimen. (c) Decontamination Requirement for Hair Specimens. A licensee shall ensure that the laboratory establishes, validates, and uses a procedure to remove possible external contamination from a hair specimen before a test is performed. (3) Security and Controlled Access. A licensee shall ensure that a specimen is collected and processed in a manner that protects the physical integrity of the specimen by: (a) Collecting and processing a specimen under supervised conditions; (b) Securing the laboratory or any portion of the laboratory used for job-related alcohol or controlled dangerous substances testing; (c) Using and maintaining secure specimen storage areas that include, when applicable, locked freezers and refrigerators; (d) Limiting access to testing and specimen storage facilities to authorized personnel; (e) Exercising and maintaining control over a specimen storage area by documenting in an access log the identity, date, time of entry and exit, and the purpose for entry for each individual who enters the storage area; and (f) Recording, reporting, and maintaining a test result in a manner that prevents alteration and breech of confidentiality by: (i) Limiting access to a test result to authorized personnel; and (ii) Preparing and storing a test result in a secured area. (4) Storage and Specimen Retention. A licensee shall ensure that a: (a) Positive urine or hair specimen is retained in the original collection container for at least 6 months after a final test result is reported; (b) Positive urine or blood specimen is stored at less than or equal to -20° Centigrade; and (c) Negative specimen is retained for at least 5 days at less than or equal to room temperature. (5) Analytical Methods and Procedures. A licensee shall ensure that tests are performed using proven and reliable methods and procedures that are approved by the: (a) Secretary; (b) College of American Pathologists (CAP); (c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or (d) United States Food and Drug Administration (FDA). (6) Approval of Methods and Procedures. The Secretary shall base approval or acceptability of any analytical method or procedure with questioned validity or reliability on evidence published in a peer-reviewed scientific journal and derived from independent: (a) Scientific testing and evaluation; or (b) Scientifically based clinical trial. (7) Accuracy, Precision, and Reliability. The licensee shall ensure that the laboratory employs quality control mechanisms and practices, including but not limited to those assuring accuracy, precision, and reliability of test results by: (a) Using a sufficient number of reference standard samples with each batch of test specimens to ensure accuracy of the assay or procedure's linearity over time; (b) Using reference standard samples that have values at or near the minimum drug detection levels or concentrations; (c) Using results obtained from testing reference standard samples to document linearity and calculate test data obtained from test specimens; (d) Including in each analytical run quality control samples that are: (i) Certified to contain no alcohol or controlled dangerous substance; (ii) Fortified with known reference standards; (iii) Positive with the alcohol or controlled dangerous substance at or near the cutoff or minimum detection level; and (iv) Using a total number of quality control samples in an analytical run equal to at least 5 percent of the number of specimens being tested; (e) Verifying and documenting at least monthly the linearity and precision of each test method and procedure; and (f) Using methods, procedures, and techniques that prevent samples and specimens from contaminating one another throughout the testing process. (8) Cutoff Levels. (a) A licensee that offers to perform or performs job-related alcohol or controlled dangerous substances testing shall use the established cutoff levels specified in §B(8)(b) and (c) of this regulation to distinguish a positive from a negative test specimen. (b) Urine. A laboratory testing urine shall use the cutoff levels set forth in 49 CFR §40.85. (c) Blood, Saliva, and Hair. (i) A licensee testing blood, saliva, or hair specimens shall use the cutoff levels established by an agency of the federal government for the purpose of determining whether a specimen is positive or negative for alcohol or a controlled dangerous substance. (ii) If cutoff levels in blood, saliva, or hair have not been established and accepted by an agency of the federal government, a licensee shall establish and use a cutoff level for each screening test and confirmatory test performed to determine whether a specimen is negative for each controlled dangerous substance that the licensee offers to detect by a screening or confirmatory procedure. (d) Validation. A licensee shall ensure that the: (i) Laboratory maintains documented data validating each cutoff level; and (ii) Cutoff data is made available for review by the OHCQ. (9) Reporting Test Results. A licensee shall ensure that a job-related laboratory test report includes: (a) A list of all the drug and alcohol tests that were performed on the specimen; (b) Positive test results only if the specimen was found positive by a confirmation test that employed a combination of: (i) Gas chromatography and mass spectrometry (GC/MS); (ii) Mass spectrometry and mass spectrometry (MS/MS); (iii) Gas chromatography tandem mass spectrometry (GC/MS/MS); or (iv) Other analytical methods that use mass spectrometry as the primary detection technique; (c) The value at the cutoff or detection level of each test, that is, screening test or confirmation test, or both, for alcohol or a controlled dangerous substance performed on the specimen; (d) The telephone number of the laboratory that may be used by an employer or individual who was tested to obtain technical assistance for the purpose of interpreting a positive test result; and (e) Except as provided in Health-General Article, §17-214(i), Annotated Code of Maryland, no information to an employer or prospective employer on: (i) The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or (ii) The use of a legally prescribed drug, unless the individual tested is unable to establish that the drug was prescribed in accordance with the laws of the State. (10) Proficiency Testing. A licensee shall ensure that the laboratory enrolls and continues to participate satisfactorily in a proficiency testing program that: (a) Covers each type of job-related alcohol and controlled dangerous substance test specimen analyzed; and (b) Has the approval of the Secretary as set forth in COMAR 10.10.05.03 of this subtitle. #### Regulation .09 Repealed. *COMAR 10.10.06.09* #### Regulation .10 Quality Control — Cytology. *COMAR 10.10.06.10* A. Primary Standard. A licensee of a laboratory offering to perform or performing tests in the subdiscipline of gynecologic cytology shall ensure that the laboratory: (1) Limits the number of slides an individual may examine as set forth in 42 CFR §493.1274; (2) Limits slide examination to the laboratory premises; (3) Establishes a quality assurance program and follows written quality control procedures to monitor and evaluate the quality of cytological procedures and testing processes; (4) Does not pay for the examination of cytology slides on a piecework basis; (5) Reviews not less than 10 percent of all negative gynecologic slides before reporting results on those slides; (6) Employs an individual who qualifies as a supervisory cytotechnologist or a technical supervisor in gynecologic cytology to review negative gynecologic slides; (7) Does not allow the evaluation of a slide that shows evidence of unsatisfactory preparation; (8) Reports as to whether a slide is satisfactory or unsatisfactory for evaluation; (9) Maintains records for 5 years of slides reported as unsatisfactory; (10) Maintains and stores for 5 years from the date of examination any slide that was examined; (11) Retains cytology reports for at least 10 years; (12) Does not send gynecologic cytology slides to a laboratory not holding a State license; and (13) Requires cytotechnologists and pathologists to obtain continuing education. B. Standards. (1) General. A licensee shall ensure that the laboratory complies with the applicable requirements in 42 CFR §493.1221. (2) Continuing Education. (a) A cytotechnologist or pathologist who is employed by a laboratory and who performs primary gynecologic screening shall obtain at least 20 credit hours per calendar year of continuing education in cytology. A credit hour is 1 hour of active participation in the educational activity. (b) An individual may obtain cytological continuing education in a formal or informal educational activity, such as reading journal articles, reviewing case histories, and attending lectures or workshops. This activity provides the individual with increased medical or technical knowledge of cytopathology or exfoliative cytology. (c) A licensee shall ensure that the laboratory annually compiles records of the continuing education for each cytotechnologist and pathologist and retains them for at least 2 years. #### Regulation .11 Quality Control — Dermatopathology. *COMAR 10.10.06.11* A. Primary Standard. In addition to meeting the requirements of other applicable regulations of this subtitle, a licensee of a laboratory performing tests in the subdiscipline of dermatopathology shall ensure that the laboratory: (1) Retains the services of either a: (a) Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1); or (b) Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4); (2) Maintains applicable records and reports; and (3) Effectively processes and stores specimens, slides, and tissue. B. Standards. (1) Maintenance of Records, Reports, Tissue, and Slides. (a) A licensee shall ensure that the laboratory maintains a system of documentation to monitor the collection, receipt, handling, transport, processing, testing, and reporting of all specimens. (b) A system of documentation may include: (i) A laboratory specimen log book; or (ii) Accession sheets or records. (c) A licensee shall ensure that the laboratory generates a written report for each patient specimen that is examined either microscopically or macroscopically. The report shall include: (i) Patient name, age, and sex; (ii) The dates of specimen collection and processing; (iii) The source or anatomic site of a specimen; (iv) A gross description of the specimen; (v) A description of the tissue, for example, bisected, submitted in total, number of blocks, or that only representative sections were submitted; (vi) The diagnosis or observed results of the test or examination; (vii) The examining physician's name, signature, and date of report; (viii) If appropriate, the clinical impression or differential diagnosis; and (ix) Other pertinent or essential patient history that may affect the accuracy or reliability of the report. (d) A licensee shall ensure that a laboratory retains: (i) Records and reports for at least 10 years for final reports and 2 years for other laboratory records; (ii) Wet tissue or tissue remnants for 2 weeks after a final report is issued; (iii) A specimen or tissue in a paraffin block for 5 years from the date of examination; and (iv) Slides for 10 years from the date of examination. (e) A licensee shall ensure that specimens, slides, and tissues are: (i) Processed in a facility licensed under this chapter; (ii) Appropriately fixed for the tests performed; (iii) Properly labeled with at least the patient's name or other cross-referenced identifier, such as a case or accession number; and (iv) Adequately stored and effectively filed to allow easy access and retrieval. (2) Quality Control. When a slide or specimen is processed or stained in the laboratory, the licensee shall ensure that: (a) A staining container is labeled and covered when not in use; (b) A stain and a working solution are changed at appropriate intervals; and (c) Routine employee access is provided to flowcharts and other written procedures that accurately reflect the procedures in use. #### Regulation .12 Quality Control — Temporary and Mobile Laboratories: General. *COMAR 10.10.06.12* A. Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed: (1) Under effective supervision, quality control, and safety procedures; (2) Using a previously evaluated analytical system; and (3) For a job-related screening test for alcohol or controlled dangerous substances, only at the request of an individual authorized in COMAR 10.10.06.02. B. Standards. (1) Limited Tests. A person may perform at a temporary or mobile laboratory only the health awareness tests defined in COMAR 10.10.01.03B and job-related screening tests for alcohol or controlled dangerous substances. (2) Health awareness and cholesterol testing may be performed at the request of the examinee. Staff who perform the tests shall have training and experience to perform testing that includes: (a) Operation of the analyzers per manufacturer’s recommendations; (b) Evaluation of the results of the quality controls; (c) Interpretation of the test results; and (d) Counseling to the individual whose specimen is tested. (3) Supervision. A designated supervisor, knowledgeable in all aspects of the health awareness testing, shall be present at a temporary or mobile laboratory throughout a testing event to oversee testing, including compliance with all applicable requirements set forth in this chapter. (4) Testing Sites. (a) A person may not perform a health awareness test in a restaurant where food or drink is prepared, served, or consumed. (b) A licensee shall ensure that a temporary laboratory: (i) Provides space, when applicable, for counseling examinees regarding test results; (ii) Provides space appropriate for the number of staff, analytical systems, and examinees; (iii) Provides work space adequate to minimize problems of transportation, communication, and safety; (iv) Provides electricity of the type and in the amount needed to operate analytical systems properly; (v) Includes access to water and disinfectant supplies for routine cleaning and disinfection of the work area, equipment, and personnel; (vi) Contains or is within 1 minute of a telephone with access to emergency assistance by calling 911; (vii) Maintains levels of temperature, humidity, and ventilation to comply with manufacturer's specifications for effective operation of analytical systems; (viii) Is situated a minimum of 12 feet from any produce, meat, or dairy department in a food market; (ix) Maintains partitions, such as ropes, on at least three sides of an area where blood is drawn or processed, to prevent unsupervised access to a blood-drawing or testing area; (x) Employs separate receptacles for routine laboratory and special medical wastes within partitioned testing areas; (xi) Provides for the storage of reagents and other testing materials within temperatures recommended by the manufacturer; and (xii) Complies with all pertinent State laws and local ordinances. (5) Pre-Field Evaluation of Analytical Systems. A licensee may not employ an analytical system in a mobile or temporary laboratory until the laboratory has documented the analytical system's levels of accuracy and precision in a permanent laboratory facility. (6) In-Field Quality Control. A licensee operating a mobile or temporary laboratory shall establish and maintain a continuous quality control program for an analytical system operated in that mobile or temporary laboratory. (7) Phlebotomy Quality Control and Safety. (a) A licensee employing a phlebotomist at a temporary or mobile laboratory shall ensure that the phlebotomist is trained in proper techniques for: (i) Specimen collection; and (ii) Infection control. (b) A licensee shall provide appropriate protective clothing and disposable gloves and ensure that they are used appropriately by all personnel involved in drawing or handling blood. (c) A phlebotomist shall wear new gloves for each examinee. (d) A laboratory employee shall use and clean phlebotomy devices as prescribed by the manufacturer. (8) Testing Logs. A licensee shall maintain for 2 years a log identifying all: (a) Persons tested; (b) Test results; and (c) Test dates. (9) Results Reporting. The licensee of a temporary or mobile laboratory: (a) May give results of a health awareness test immediately following the testing directly to the individual who underwent the test; and (b) Shall give the test results in writing stating the: (i) Name of the individual tested, (ii) Name of the laboratory performing the test, (iii) Name of the test, (iv) Date of the test, and (v) Test result with appropriate interpretation or reference range consistent with current nationally recognized standards. (10) Disposal of Special Medical Waste. A licensee operating a temporary or mobile laboratory shall dispose of special medical waste as required in COMAR 10.06.06.01—10.06.06.07. #### Regulation .13 Quality Control — Temporary and Mobile Laboratories: Personnel Training. *COMAR 10.10.06.13* A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties. B. Standards. (1) All Personnel. A licensee shall ensure that all personnel are trained to: (a) Keep examinees' health information confidential; (b) Deal with emergency situations such as fainting and anxiety reactions; (c) Report and document information on testing services and activities; and (d) Dispose of special medical waste as set forth in COMAR 10.06.06.01—10.06.06.07. (2) Phlebotomist. A licensee shall ensure that an individual who collects blood specimens is trained in: (a) Specimen collection methods; and (b) Infection control and prevention techniques, including CDC recommendations for preventing the transmission of bloodborne pathogens in health care settings. (3) Operator of an Analytical System: General. A licensee shall ensure that an operator of an analytical system is trained in: (a) Infection control and prevention techniques, including CDC recommendations concerning the transmission of bloodborne pathogens in health care settings; and (b) Proper use of the analytical system, including: (i) Analytical system operation; (ii) System methods used to process the specimen; and (iii) Quality control techniques, procedures, and requirements. (4) Operator of an Analytical System: Competency. (a) Obtaining Personal Competency. Before an individual may operate an analytical system without direct supervision, the individual operator shall demonstrate competency in operating the analytical system by completing: (i) Pre-field supervised practice that includes performing under direct supervision a minimum of ten tests of each applicable type of health awareness test; and (ii) Field testing experience that includes individual performance of directly supervised testing in the field. (b) Documenting Training and Competency. The licensee shall document in writing that each analytical system operator has demonstrated competency as required under this regulation. #### Regulation .14 Quality Control — Temporary and Mobile Laboratories: Event Registration. *COMAR 10.10.06.14* A. Primary Standard. In addition to meeting other applicable requirements set forth in this chapter, a licensee intending to perform a health awareness test at a temporary or mobile laboratory shall register the testing event with the Department before the testing event may occur. B. Standards. (1) A licensee shall inform the OHCQ by phone or in writing of the date, time, location, and on-site supervisor's name for a testing event at least 14 days before the event is to take place. (2) A licensee shall display in a public place at the testing site and throughout the testing event a copy of the laboratory's license. #### Regulation .15 Quality Control — Temporary and Mobile Laboratories: Cholesterol and Health Awareness. *COMAR 10.10.06.15* A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee offering to perform or performing cholesterol or health awareness testing at a temporary or mobile laboratory shall ensure that the laboratory: (1) Develops and maintains a written SOPM; (2) Validates the analyzer initially and utilizes the manufacturer’s reference range for the quality control with each new lot of quality control; (3) Employs and maintains an in-field quality control program; (4) Reports test results as set forth in §B(5) of this regulation; and (5) Informs examinees of test limitations based on current nationally recognized standards for each test performed. B. Standards. (1) Supervisor. A supervisor knowledgeable in all aspects of health awareness testing shall oversee all cholesterol or health awareness testing conducted at a temporary or mobile laboratory. (2) SOPM. (a) A licensee shall develop and maintain a written SOPM covering all current procedures for: (i) Training personnel; (ii) Analytical system maintenance; (iii) Testing participants and quality control; (iv) Retesting; (v) Documenting lot numbers and expiration dates of quality control materials and reagents (cassettes) used for participant testing; (vi) Evaluation of quality controls on site and documentation of corrective actions when quality control results are unacceptable; (vii) An every 6 month evaluation of all analyzers used in Maryland using the worksheet provided by the Department; and (viii) Other aspects of the cholesterol and health awareness testing service's activities. (b) The general supervisor or director shall initially approve and when changes are made review, sign, and date the SOPM. (c) All personnel shall have routine access to a copy of the SOPM at each testing site throughout each testing event. (3) Method Verification and Pre-Field Evaluation of an Analytical System. A licensee shall evaluate each analytical system by: (a) Performing a method verification to demonstrate that the system produces test results within limits of accuracy and precision, as defined by either the licensee or the system's manufacturer, before the system may be used at a temporary or mobile laboratory; and (b) Analyzing two levels of quality control materials. (4) In-field Quality Control. At a temporary or mobile laboratory, a licensee shall maintain a continuous quality control program in which: (a) Each person who performs tests at a screening event shall test both levels of quality control samples identified in §B(3)(b) of this regulation on one analyzer for each cholesterol and health awareness test performed at the screening event; (b) Quality control testing shall be performed on at least one analyzer, if more than one analyzer at a screening event is used; (c) Each testing person shall test two levels of quality control materials on another analyzer at the beginning of the cholesterol or health awareness event if more than one person is performing tests at an event; and (d) The laboratory shall complete the comparison worksheet designated by the Department quarterly to ensure that all the analyzers used for reporting test results produce results within 15 percent to 20 percent of the other analyzers. (5) Examinee results shall be reported above the established reportable range of the instrument, that is, analytic range, as greater than the highest reference point, with the analytic range being determined by pre-field testing. (6) Reporting and Releasing Test Results. (a) A licensee shall release cholesterol or health awareness test results only to the examinee or their physician in writing and in a manner to protect the confidentiality of the test results. (b) A licensee shall include the following on its reports: (i) The name, address, and phone number of the laboratory performing the test; (ii) The date and location of the testing; and (iii) The signature, initials, or electronic authentication of a laboratory employee. (c) A laboratory shall provide to an examinee a written explanation of all cholesterol and health awareness test results and refer the examinee for medical care when indicated by the results. ### Chapter 07 — Medical Laboratories — Personnel **Authority:** Health-General Article, §§17-202, 17-203, 17-206, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .07B amended effective March 1, 2026 (52:24 Md. R. 1198) #### Regulation .01 Permitted POL and POCL — Director and Associate Director. *COMAR 10.10.07.01* A. Primary Standard. The licensee of a permitted POL or POCL shall employ or otherwise engage the services of a qualified director or associate director and a laboratory supervisor or consulting supervisor. B. Standards. (1) Qualifications. (a) POL. The director of a permitted POL shall be: (i) A physician licensed by the Board of Physicians to practice medicine in the State and a member or employee of the practice operating the laboratory; or (ii) An employee or contractor of the practice who possesses the training and experience set forth in Regulation .05 of this chapter. (b) POCL. The director of a permitted POCL shall be: (i) A physician of the medical care facility who possesses the applicable training and experience set forth in Regulation .05 of this chapter; (ii) An individual who qualifies as a director under 42 CFR §493.1443, and who possesses the applicable training and experience set forth in Regulation .05 of this chapter; or (iii) An individual who meets the definition of a technologist as set forth in COMAR 10.10.01.03B. (2) Duties and Responsibilities. (a) A director of a permitted POL or POCL shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations to the extent necessary to ensure compliance with this chapter. (b) A director's duties and responsibilities include: (i) When applicable, employing or otherwise engaging the services of a qualified general supervisor or consulting supervisor; (ii) Ensuring that the general supervisor or consulting supervisor spends sufficient time performing the supervisory duties and responsibilities; (iii) Completing and submitting to the OHCQ forms, supplied by the OHCQ, that document a general or consulting supervisor's education, training, and experience in laboratory practice; (iv) Recruiting qualified and competent technical personnel; (v) Obtaining or providing and documenting initial training and continuing education for technical personnel; (vi) Reviewing with the laboratory supervisor or consulting supervisor all laboratory procedures and policies and all evaluative material, including proficiency testing results, pertinent to the operation and performance of the laboratory; (vii) Serving as a liaison between the physicians of the practice or medical care facility and the laboratory supervisor or consulting supervisor and other technical personnel to communicate situations such as test interpretations, timeliness of reports, reporting abnormal test results, and new or changing laboratory procedures and policies affecting patient care; (viii) Ensuring that all application forms, documents, and other materials required under this chapter are submitted to the OHCQ within the appropriate time periods; and (ix) Designating an associate director, when applicable. (3) Associate Director. An associate director shall: (a) Meet the same qualifications as set forth in §B(1) of this regulation; and (b) Act as laboratory director when the laboratory director is away from the laboratory for a period of more than 30 days. (4) Supervisory Consultation. A director of a permitted POL or POCL shall: (a) Consult with the laboratory supervisor in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory; and (b) Conduct an on-site visit to each directed laboratory at least once a month. (5) Director Limitation. A POL director may not serve as director or associate director, or both, of more than five medical laboratories at the same time. (6) Changes in Employment or Service. A director shall notify the OHCQ within 30 days of any change in the director's service or employment as a laboratory director. (7) Director Disqualification. A director or associate director may be disqualified to direct a permitted POL for failing to comply with the applicable standards and requirements of this chapter. #### Regulation .02 Permitted POL and POCL — General Supervisor and Consulting Supervisor. *COMAR 10.10.07.02* A. Primary Standard. A licensee operating a POL or POCL under a permit shall employ or otherwise engage a qualified general supervisor or consulting supervisor. B. Standards. (1) Requirement. A laboratory shall employ or otherwise engage a qualified general supervisor or consulting supervisor who shall act in concert with the laboratory director to ensure that the laboratory complies with the standards and requirements of this chapter. (2) Qualifications — POL and POCL General Supervisor. To qualify as a laboratory supervisor in a permitted POL or POCL, an individual shall be a: (a) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised; (b) Technologist as defined in COMAR 10.10.01.03B and employed to perform tests at least 1 day a week in the lab being supervised; or (c) Technician as defined in COMAR 10.10.01.03B and employed to perform tests on a full-time basis in the lab being supervised. (3) Qualifications — Consulting Supervisor. To qualify as a consulting supervisor of a POL or POCL, an individual shall be a: (a) Technologist as defined in COMAR 10.10.01.03B who possesses at least 2 years of work experience in a laboratory that: (i) Operated under a permit; and (ii) Performed testing services related to those offered by the laboratory to be supervised; or (b) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised. (4) Supervisory Duties and Responsibilities. A general supervisor or consulting supervisor shall: (a) Implement and maintain the applicable laboratory standards and requirements set forth in this chapter; (b) Ensure proper and reliable test performance, reporting, record keeping, and immediate general and technical supervision of testing personnel and laboratory services; (c) Develop, implement, and oversee maintenance of an internal quality assurance program that includes: (i) A working quality control program or system that determines and documents accuracy and precision of all tests performed; (ii) Selection and use of quality control and standard materials for analysis; (iii) Recording and documenting quality control data; (iv) Ongoing analysis of quality control data; and (v) Implementation and maintenance of a specimen documentation and management system; (d) Prepare and maintain a SOPM; (e) Ensure full participation in an external proficiency testing program approved by the Secretary as set forth in COMAR 10.10.05.03; (f) Teach proper laboratory techniques, including the importance of quality control, quality assurance, and proficiency testing; (g) Review proficiency testing results, determine sources of error, and work to correct any problems; (h) Review proficiency testing results, analytical studies and evaluations, and survey reports with technical personnel to improve test performance and laboratory services; (i) Maintain, as part of laboratory records, a log or other suitable record documenting monthly consultations with the director and all supervisory activities provided to the laboratory; (j) Ensure that laboratory testing personnel: (i) Possess the education, training, and experience required to perform and report laboratory test results accurately and promptly; (ii) Are sufficient in number for the scope and complexity of the services provided; (iii) Receive regular in-service training and continuing education appropriate for the scope and complexity of the services provided; and (iv) Maintain competency in performing test procedures and reporting test results; and (k) Perform other duties and responsibilities as delegated and authorized by the director that may include assisting in: (i) Developing cost benefit data; (ii) Identifying and recommending adjustments to a laboratory's scope of services; and (iii) Recommending the purchase or replacement of test kits, reagents, and equipment. #### Regulation .03 Permitted POL and POCL — Consulting Supervisor Services. *COMAR 10.10.07.03* A. General. (1) A licensee operating a permitted POL or POCL who does not employ or otherwise engage technical personnel who qualify as a general supervisor shall arrange with a qualified consulting supervisor to provide technical and general supervisory consultation services in laboratory practice. (2) The licensee operating a POL or POCL under a permit shall use a consulting supervisor who: (a) Makes and documents on-site visits to each laboratory facility at least twice each calendar year; (b) Is available by telephone during the laboratory's regular operating hours; and (c) Completes a laboratory inspection checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once every 2 years. B. Additional Visits. The OHCQ may require more than two on-site visits per year by a consulting supervisor when: (1) A laboratory exhibits unsatisfactory proficiency testing performance; (2) An on-site survey by the OHCQ shows that: (a) A laboratory is not in substantial compliance with the applicable standards and requirements of this chapter; (b) A laboratory's written plan of correction in response to a Department survey does not ensure substantial compliance with the applicable standards and requirements of this chapter; or (c) A laboratory's testing personnel require additional supervisory consultations to obtain or maintain proficiency in quality assurance, performing or reporting test results, or meeting other applicable standards of this chapter; (3) An inspection checklist submitted by the laboratory shows that the laboratory is operating in a manner that is not in compliance with applicable standards of this chapter; or (4) The laboratory's general supervisor or consulting supervisor has been unable to perform the duties and responsibilities set forth in Regulation .02B(4) of this chapter. #### Regulation .04 Permitted Laboratory Other than a POL or POCL — Director. *COMAR 10.10.07.04* A. Primary Standard. A licensee operating a permitted laboratory other than a POL or POCL shall employ a director who meets the applicable qualifications, responsibilities, and standards set forth in this chapter. B. Standards. (1) Qualifications. In addition to applicable personnel standards set forth in this chapter, a director shall meet the applicable standards set forth in 42 CFR §493.1443. (2) Responsibilities. A director shall carry out the applicable responsibilities set forth in 42 CFR §§493.1407 and 493.1445. (3) Associate Director. A director shall designate another individual who qualifies as a director under this chapter to serve as an associate or substitute director when the director: (a) Will be away from the laboratory for a period of more than 30 days; or (b) Is unable to carry out the responsibilities set forth in §B(2) of this regulation. (4) Communications. A director shall communicate with the laboratory's supervisory personnel in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory. (5) On-site Visits. A director of a laboratory shall conduct an on-site visit of the laboratory at least once a month. (6) Limitation. The director of a permitted laboratory may not serve as director or associate director, or both, of more than five medical laboratories at the same time. #### Regulation .05 Permitted Laboratories — Technical Supervisors. *COMAR 10.10.07.05* A. Primary Standards. (1) A laboratory director certified, or eligible for certification, in anatomic and clinical pathology by the American Board of Pathology qualifies as a technical supervisor in all disciplines and subdisciplines set forth in COMAR 10.10.01.03B, except: (a) Genetics; and (b) Forensic toxicology. (2) A licensee who does not employ or otherwise engage a director certified in anatomic and clinical pathology by the American Board of Pathology, or a licensee operating a laboratory that performs testing in the discipline of genetics or forensic toxicology shall employ the services of a technical supervisor for each discipline set forth in COMAR 10.10.01.03B except the discipline of health awareness testing. (3) A technical supervisor shall carry out the applicable responsibilities set forth in 42 CFR §493.1451. B. Standards. (1) Requirement. A licensee operating a laboratory that performs testing in one or more disciplines shall employ a director or technical supervisor who meets the qualifications for a technical supervisor in the applicable disciplines or subdisciplines set forth in §B(2)—(13) of this regulation. (2) Chemistry. A technical supervisor shall possess a bachelor's or higher degree including significant studies in chemistry and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical chemistry. (3) Gynecologic Cytology. A technical supervisor shall meet the requirements set forth in 42 CFR §493.1449. (4) Dermatopathology. A technical supervisor shall be: (a) A physician licensed by the Board of Physicians to practice medicine in the State; and (b) Either certified or eligible for certification in dermatopathology or anatomic pathology by the: (i) American Board of Dermatology; (ii) American Osteopathic Board of Dermatology; (iii) American Board of Pathology; or (iv) American Osteopathic Board of Pathology. (5) Forensic Toxicology — General Qualifications. A technical supervisor shall: (a) Be certified in toxicological chemistry by the American Board of Clinical Chemistry; (b) Be certified in forensic toxicology by the American Board of Forensic Toxicology; (c) Be certified in clinical pathology and chemistry by the American Board of Pathology; or (d) Possess education and experience in toxicology equivalent to that required by one of these boards. (6) Forensic Toxicology — Alternative Qualifications. An individual who does not qualify as a technical supervisor under §B(5) of this regulation may qualify as a technical supervisor if the individual: (a) Can document training or experience, or both, in the: (i) Analysis of biological material for alcohol or controlled dangerous substances, or both; and (ii) Forensic applications of analytical toxicology, such as court testimony, use of chain of custody, and specimen security; and (b) Possesses: (i) A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians, with certification in clinical pathology or forensic pathology, and have at least 2 years of laboratory experience in analytical toxicology; (ii) A doctoral degree in a biological, chemical, pharmacological, or toxicological discipline and have at least 2 years of laboratory experience in analytical toxicology; or (iii) A master's degree in a biological, chemical, pharmacological, or toxicological discipline with at least 6 years of experience in analytical toxicology. (7) Genetics. A technical supervisor of biochemical genetics, cytogenetics, or molecular genetics shall possess: (a) A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians; or (b) An earned doctorate in one of the biological or chemical sciences from an accredited institution with: (i) 4 years of laboratory experience in genetics; or (ii) Eligibility for certification by the American Board of Medical Genetics. (8) Hematology. A technical supervisor shall possess a baccalaureate or higher degree including studies in biology or general cytology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in hematology. (9) Immunology. A technical supervisor shall possess a baccalaureate or higher degree including studies in immunology, microbiology, or chemistry and have at least 4 years post-baccalaureate or 2 years post-master's experience in immunology-serology. (10) Microbiology. A technical supervisor shall possess a baccalaureate or higher degree including studies in microbiology or immunology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical microbiology. (11) Molecular Biology. A technical supervisor shall possess a baccalaureate or higher degree including studies in molecular biology and have at least 4 years post-baccalaureate or 2 years post-master's experience in molecular biology, microbiology, immunology, or clinical chemistry. (12) Oral Pathology, Including Oral Cytopathology. A technical supervisor shall be a dentist or physician licensed to practice in Maryland and be certified or eligible for certification by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology. (13) Tissue Pathology. A technical supervisor shall be a physician licensed to practice medicine in Maryland and be certified or eligible for certification in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. #### Regulation .06 Permitted Laboratory Other than a POL or POCL — Supervisors. *COMAR 10.10.07.06* A. Primary Standard. A licensee operating a laboratory other than a POL or POCL shall employ a qualified supervisory technologist or general supervisor, who in the absence of the director or technical supervisor is responsible for the proper performance of laboratory procedures and reporting of laboratory test results. B. Standards: General Supervisor. (1) Personnel Qualifications. A general supervisor shall be a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than a laboratory operating under a letter of exception. (2) Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463. C. Standards: Supervisory Cytotechnologist. (1) Personnel Qualifications. For the specialty of cytology, a laboratory shall employ the services of a supervisory cytotechnologist who meets the qualifications set forth in 42 CFR §493.1469. (2) Responsibilities. A supervisory cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1471. D. Standards: Supervisor of Blood Gas Analyses. An individual qualifies as a supervisor of blood gas analyses by: (1) Possessing an earned doctoral, master's, or baccalaureate degree in respiratory care or cardiovascular technology; and (2) Meeting the personnel qualifications set forth in 42 CFR §493.1449. #### Regulation .07 Permitted Laboratory Other than POL or POCL — Testing Personnel. *COMAR 10.10.07.07* A. Primary Standard. A permitted laboratory other than a POL or POCL shall employ or engage testing personnel, sufficient in number to perform testing for the volume and complexity of testing performed, who meet the qualifications and carry out the responsibilities set forth in this regulation. B. Standards — General. (1) Personnel Qualifications. An individual performing one or more laboratory tests shall meet the applicable qualifications set forth in 42 CFR §493.1423. (2) Responsibilities. Testing personnel shall carry out the responsibilities set forth in 42 CFR §493.1425. C. Standards — Cytotechnologist. (1) Personnel Qualifications. For the specialty of cytology, a licensee shall employ the services of cytotechnologists who meet the qualifications set forth in 42 CFR §§493.1483. (2) Responsibilities. A cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1485. D. Standards — Blood Gas Analysis — Personnel Qualifications. Personnel performing blood gas analyses shall: (1) Meet the standards set forth in 42 CFR §493.1489; or (2) Complete a 1-year certificate program in respiratory care. ### Chapter 08 — Medical Laboratories — Sanctions **Authority:** Health-General Article, §§17-202, 17-206, 17-210, 17-211, and 17-509, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02A, B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05 adopted effective March 27, 2006 (33:6 Md. R. 578) #### Regulation .01 General. *COMAR 10.10.08.01* A. Authority and Types. (1) The Secretary may impose one or more principal or alternative sanctions. (2) Principal Sanctions. The Secretary may impose the following principal sanctions: (a) Denial of a license; (b) Suspension of a license; and (c) Revocation of a license. (3) Alternative Sanctions. Instead of or in conjunction with lifting a principal sanction, the Secretary may impose one or more of the following alternative sanctions: (a) A directed plan of correction; (b) Limitation on testing; and (c) Training and technical assistance. B. Reasons for Imposition. A laboratory is subject to the imposition of one or more sanctions when the OHCQ finds: (1) A deficiency identified through an on-site survey or a review of materials submitted by a laboratory, such as applications data, personnel qualification materials, and self-inspection checklists; (2) Unsuccessful proficiency testing performance; (3) Demonstrated incompetence, such as showing consistent or repetitive errors in operating equipment or in performing a test or procedure; (4) False statements made on an application, plan-of-correction, or other form submitted to the OHCQ; (5) Misrepresentation in obtaining a permit or letter of exception or in operating a laboratory; (6) Failure to comply with the: (a) Cancer reporting requirements of Health-General Article, §18-204, Annotated Code of Maryland; and (b) Infectious disease and submission of clinical material requirements of Health-General Article, §18-205, Annotated Code of Maryland, and COMAR 10.06.01; (7) Submission of a specimen by a laboratory inside the State to another laboratory that does not possess a license as set forth in COMAR 10.10.03; (8) Conviction by a court of a violation of the laws of the State pertaining to a medical laboratory; or (9) Exceeding the 50 test per year limit when operating under a letter of exception—limited testing for rare diseases as set forth in COMAR 10.10.03.05B. C. Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a laboratory based on, but not limited to, the following: (1) Whether a deficiency poses immediate jeopardy to personal or public health or safety; (2) The nature, incidence, severity, and duration of the deficiency; (3) Whether a deficiency has been identified repeatedly; (4) The inaccuracy or extent of missing laboratory records, such as missing documentation of remedial action or failure to make records available to the OHCQ; (5) The relationship of one deficiency or group of deficiencies to another deficiency; (6) The overall compliance history of a laboratory, including but not limited to any period of noncompliance that occurred between determinations of compliance; (7) The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and (8) The progress a laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency. D. Mandatory Revocation of a License. The Secretary shall revoke for 1 year the license of a laboratory that intentionally refers a proficiency test sample to another laboratory for analysis. E. Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a laboratory that has had its license revoked may not, within 1 year of the revocation, apply for a license, or own or operate a laboratory for which a license has been issued under this chapter. #### Regulation .02 Departmental Actions — General. *COMAR 10.10.08.02* A. Deficiency Posing Immediate Jeopardy. (1) If a laboratory's deficiency poses immediate jeopardy to personal or public health or safety, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation. (2) Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall: (a) Require the laboratory to take immediate action to remove the jeopardy; and (b) Impose: (i) A principal sanction after giving the laboratory at least 24 hours notice; or (ii) One or more alternative sanctions. (3) Follow-up Actions. If the OHCQ finds in a follow-up survey of a laboratory under an alternative sanction that the laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the laboratory at least 24 hours notice. B. Deficiency Not Posing Immediate Jeopardy. (1) If a laboratory's deficiency does not pose immediate jeopardy to personal or public health or safety, the Secretary may take one or more of the actions listed in §B(2) — (4) of this regulation. (2) Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction. (3) Unsatisfactory Proficiency Testing. If a laboratory exhibits unsatisfactory proficiency testing performance, as set forth in COMAR 10.10.01.03B, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction. (4) Follow-up Actions. If the OHCQ finds in a follow-up survey that a laboratory has not corrected a deficiency within 30 days after it was identified, the Secretary may: (a) Impose, or continue if already imposed, one or more sanctions; (b) Conduct one or more on-site visits to evaluate progress in correcting a deficiency; and (c) Conduct an additional follow-up survey to determine whether all corrections have been made. C. Duration of a Sanction. A sanction shall remain in force until: (1) A laboratory corrects the deficiency; or (2) A laboratory's license is revoked. D. Lifting of a Sanction. (1) General Rule. The Secretary may not lift a sanction until regulatory compliance is verified. (2) Credible Allegation of Compliance. When a sanctioned laboratory submits a credible allegation of compliance, the Secretary shall: (a) Determine compliance on the basis of the evidence submitted by the laboratory in its allegation; (b) Conduct a follow-up survey to verify whether the laboratory has achieved compliance; or (c) Both §D(2)(a) and (b) of this regulation. (3) If a laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license. #### Regulation .03 Departmental Actions — Principal Sanctions. *COMAR 10.10.08.03* A. Hearing Requirement. (1) Except when the Secretary finds that a danger to public health or safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing when a suspension or revocation of the licensee's license takes effect, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland. (2) When a finding is made that the public health or safety imperatively requires that emergency or immediate action be taken, the Secretary shall inform the licensee in writing of a suspension or revocation of the licensee's license, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, after the suspension or revocation. B. Notice. (1) Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the: (a) Deficiency identified; (b) Sanction proposed for imposition; (c) Reason for the proposed sanction; (d) Projected effective date and duration of the proposed sanction; (e) Authority for the proposed sanction; and (f) Time allowed for a laboratory to respond to the notice. (2) Opportunity to Respond. During the time allowed and stated in the written notice, a laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions. (3) Notice Times. (a) If a deficiency is found imperatively to require emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of sanction. (b) If a deficiency is found to warrant a principal sanction but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction. (c) To preserve its right to a hearing, a licensee shall request a hearing within 10 days of its receipt of the notice of the pending sanction. #### Regulation .04 Enforcement Procedures — Proficiency Testing. *COMAR 10.10.08.04* A. Application. If a laboratory's performance in proficiency testing is unsuccessful or unsatisfactory, as set forth in COMAR 10.10.05, the Secretary may require the laboratory to undertake the directed plan of correction of the training of its personnel or the obtaining of necessary technical assistance, or both, in order to meet the proficiency testing requirements of this chapter. B. Procedures. A laboratory required to undertake training of personnel or to obtain necessary technical assistance shall: (1) Document the training or assistance, or both, using forms provided by the OHCQ; and (2) Submit the completed forms to the OHCQ. #### Regulation .05 Departmental Action — Reporting Erroneous or Questionable Patient Test Results. *COMAR 10.10.08.05* A. If the Department determines that a licensee has reported an erroneous or questionable patient test result that threatens the health or safety of the patient, the Secretary may order the licensee, within a specified period of time, to: (1) Give prompt notice of the erroneous or questionable patient test result to the: (a) Person who requested that the test be performed; and (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; (2) Provide corrected reports to the persons notified in §A(1) of this regulation; (3) Maintain duplicates of both the original report and the corrected report; (4) Conduct a quality assessment of all phases of the testing process to: (a) Determine the cause of the erroneous or questionable test result; and (b) Take the necessary remedial or corrective action to prevent recurrence of the problem; and (5) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including: (a) Notifying the: (i) Patient; (ii) Community at large if the Secretary determines that the licensee's laboratory operation is a threat to patient health and safety; and (iii) If the licensee is unable to notify a patient, the Department; and (b) Retesting: (i) The same specimen; (ii) A new specimen; or (iii) Both the same specimen and a new specimen. B. Civil Penalty for Failure to Comply with Order. (1) A laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000. (2) The Secretary may impose the civil penalty instead of or in addition to any other sanction imposed under this chapter. C. Notice and Hearing. (1) Notice. Before the Secretary imposes a civil penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to the licensee: (a) Of the intent to impose a civil money penalty; and (b) That the licensee has an opportunity for a hearing on the matter before the civil penalty is imposed. (2) Content. The Secretary shall give written notice to the licensee of the: (a) Reason for the imposition of the civil penalty; (b) Amount of the civil penalty; (c) Effective date of the imposition of the civil penalty; (d) Time allowed for the licensee to respond to the notice; and (e) Authority for imposing the civil penalty. (3) Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this regulation or Health-General Article, §17-210, Annotated Code of Maryland. (4) To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary's intent to impose the civil penalty. D. Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil penalty is appropriate, the Secretary shall take into consideration the following factors in determining the amount of the penalty: (1) The extent to which the licensee derived any financial benefit from reporting erroneous or questionable patient test results; (2) The willfulness on the part of the licensee; (3) The extent of actual or potential public harm caused by reporting erroneous or questionable patient test results; (4) The cost of investigating and prosecuting the case against the licensee; (5) The licensee's history of previous failure to meet the standards of this subtitle; and (6) The existence of mitigating factors. E. Payment of Penalties. (1) At the Secretary's discretion, the Secretary may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. (2) All monies collected by the Secretary pursuant to this regulation shall be paid into the General Fund of the State. ### Chapter 09 — Forensic Laboratories — Personnel Certification and Approval of Laboratory Procedures **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §17-2A-02; Annotated Code of Maryland **Administrative History:** Effective date: March 11, 1985 (12:5 Md. R. 483) **Administrative History:** Regulation .02A amended effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulations .03 and .04 repealed, new Regulations .03—.06 adopted effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .05 recodified as Regulation .07 effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .06 amended effective March 1, 1993 (20:4 Md. R. 371) **Administrative History:** Chapter revised effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Chapter recodified from COMAR 10.10.03 and revised effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .01A amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02A amended effective November 11, 2013 (40:22 Md. R. 1877) **Administrative History:** Regulation .03 amended effective December 23, 2002 (29:25 Md. R. 1982); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .03A amended as an emergency provision effective September 10, 2019 (46:20 Md. R. 842); adopted permanently effective December 30, 2019 (46:26 Md. R. 1165) **Administrative History:** Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1982); November 11, 2013 (40:22 Md. R. 1877) **Administrative History:** Regulation .05 amended effective December 23, 2002 (29:25 Md. R. 1982) #### Regulation .01 Qualifications. *COMAR 10.10.09.01* A. Certified Chemist and Certified Chemical Analyst. An applicant for certified chemist or certified chemical analyst shall: (1) Hold a bachelor's degree from an accredited college or university with a major in chemistry, medical technology, biology, physics, pharmacy, pharmacology, or forensic science; (2) Have completed courses in analytical and organic chemistry; and (3) Have completed a basic training program for certified chemist or certified chemical analyst as set forth in Regulation .02 of this chapter. B. Certified Analyst. An applicant for certified analyst shall: (1) Possess a high school diploma or its equivalent; (2) Have completed a basic training program for certified analyst as set forth in Regulation .02 of this chapter; and (3) Identify in the application those specific drug-testing procedures for which certification is being sought and for which training has been received. #### Regulation .02 Approved Training Programs for Chemists, Chemical Analysts, and Analysts. *COMAR 10.10.09.02* A. Certified Chemist. (1) An applicant for certification as a certified chemist shall have successfully completed: (a) The basic training program for forensic drug chemists offered by the United States Department of Justice, Drug Enforcement Administration; or (b) A training program in the discipline of controlled dangerous substances provided by a forensic laboratory licensed by the Department. (2) The applicant shall demonstrate completion of the training program referenced in §A(1)(b) of this regulation by providing the Department with the forensic laboratory director’s written authorization for that individual to perform casework independently in the discipline of controlled dangerous substances. B. Certified Chemical Analyst. An applicant for certification as a certified chemical analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under Regulation .04 of this chapter. C. Certified Analyst. An applicant for certification as a certified analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, using procedures approved under Regulation .04 of this chapter. #### Regulation .03 Employment, Employment Certification, and Automatic Decertification. *COMAR 10.10.09.03* A. Employment. An individual applying for certification under this chapter shall be currently employed by: (1) The Department; (2) The Maryland State Police; (3) The Baltimore City Police Department; (4) The police department or a municipality or county in this State; or (5) A private forensic laboratory licensed by the Maryland Department of Health that has a contract with a Maryland law enforcement agency to provide testing services for controlled dangerous substances. B. Employment Certification. An applicant's supervisor shall certify that the applicant is currently employed by an agency listed in §A of this regulation by signing the employment certification section of the application. C. Certification and Automatic Decertification. (1) Certification under this chapter is only valid when the individual is employed by an agency listed in §A of this regulation. (2) An individual certified under this chapter is automatically decertified when the individual: (a) Is no longer employed by the agency that certified employment; (b) Retires from the agency that certified employment; or (c) Changes employment from one agency listed in §A of this regulation to another agency listed in §A of this regulation. (3) An individual shall reapply for certification under this chapter if the individual is: (a) Rehired by the same agency that previously certified employment; or (b) Hired by a different agency listed in §A of this regulation. #### Regulation .04 Procedures. *COMAR 10.10.09.04* Chemists, chemical analysts, and analysts certified under this chapter are certified only when performing those drug identification procedures: A. Approved by a forensic laboratory licensed by the Department; or B. Contained in the “Forensic Chemists and Analysts Training and Procedures Manual” 1992, which is incorporated by reference. #### Regulation .05 Report. *COMAR 10.10.09.05* A report prepared pursuant to these regulations shall contain the following information: A. The signature of the certified chemist, chemical analyst, or analyst performing the drug-identification procedure; B. The name of the person who delivered the material to be tested to the certified chemist, chemical analyst, or analyst; C. A statement that the chemist, chemical analyst, or analyst has been certified by the Department to perform the procedures identified in the report; D. A statement by the certified chemist, chemical analyst, or analyst that the results contained in the report were reached using procedures approved by the Department; E. A statement by the certified chemist, chemical analyst, or analyst concerning whether the material tested is, or contains, the drug identified in the report; and F. A statement by the certified chemist, chemical analyst, or analyst that quality control of the drug-identification procedures was performed to ensure the reliability of the procedures performed. ### Chapter 10 — Job-Related Alcohol and Controlled Dangerous Substances Testing **Authority:** Health-General Article, §§17-202 and 17-214, Annotated Code of Maryland **Administrative History:** Effective date: October 5, 1998 (25:20 Md. R. 1529) **Administrative History:** Chapter, COMAR 10.10.05, recodified to COMAR 10.10.10 effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .06 amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .10 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .10F amended effective July 22, 2002 (29:14 Md. R. 1074) #### Regulation .01 Purpose. *COMAR 10.10.10.01* This chapter provides for the protection of employers, employees, and the public by setting fair and effective job-related alcohol and controlled dangerous substances testing standards to ensure accurate and reliable test results and to promote drug-free workplaces. #### Regulation .02 Scope. *COMAR 10.10.10.02* A. This chapter provides the standards and procedures that employers, employees, and the Secretary shall meet when job applicants and employees are required to undergo job-related alcohol and controlled dangerous substances testing. B. This chapter does not apply to: (1) A person who is subject to federal or State commercial motor vehicle statutes or regulations concerning alcohol and controlled dangerous substances testing, to the extent that those statutes or regulations conflict with the requirements of this chapter; (2) An agency of the federal government; (3) Alcohol or controlled dangerous substances testing of an individual under arrest or held by a law enforcement or correctional agency; (4) Alcohol testing conducted by a law enforcement or correctional agency on breath-testing equipment certified by the State toxicologist; or (5) Controlled dangerous substances testing by a laboratory facility of a law enforcement or correctional agency that maintains laboratory testing standards comparable to the standards in Health-General Article, §17-214, Annotated Code of Maryland. #### Regulation .03 Definitions. *COMAR 10.10.10.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Agent of the employer” means a person other than the employer or a licensed medical laboratory that employs individuals who perform preliminary screening of job applicants for controlled dangerous substances on behalf of the employer. (2) “Chain-of-custody” means a method of tracking an individual's specimen for the purpose of maintaining control and accountability from initial collection through each stage in handling, testing, storing, reporting test results, and final specimen disposition. (3) Confirmation Test. (a) “Confirmation test” means an analytical procedure performed after a preliminary or screening test and intended to verify or positively identify the presence of a controlled dangerous substance in a specimen. (b) “Confirmation test” is limited to an analytical procedure that employs a combination of gas chromatography and mass spectrometry (GC/MS or GC/MS/MS) or mass spectrometry and mass spectrometry (MS/MS). (4) Controlled Dangerous Substance. (a) “Controlled dangerous substance” means a drug, substance, or immediate precursor as set forth in Schedules I—V, Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. (b) “Controlled dangerous substance” includes new substances controlled under federal law as provided in Criminal Law Article, §5-202, Annotated Code of Maryland. (5) Employee. (a) “Employee” means an individual who performs work for an employer. (b) “Employee” includes a salaried, contractual, full-time, part-time, temporary, hourly, and on-call employee or a volunteer. (6) “Employer” means a person who employs an individual to perform work. (7) “Forensic testing” means testing performed for a nonclinical purpose and under procedures that produce test results that meet rules of evidence required in a court of law. (8) “Immediate precursor” means a substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland. (9) “Independent test” means a test performed at the request and expense of a job applicant, employee, or contractor to verify a test result obtained on the same specimen. (10) “Job applicant” means an individual who has applied for a position with an employer but is not currently employed by the employer. (11) “Job-related testing” means any alcohol or controlled dangerous substances testing used by an employer for a lawful business purpose. (12) Laboratory. (a) “Laboratory” means a facility, entity, or site that performs job-related alcohol or controlled dangerous substances testing. (b) “Laboratory” does not include a collection site or other site where an employer or agent of the employer performs preliminary screening of job applicants for a controlled dangerous substance using a single-use test device for forensic testing. (13) “Letter of registration” means the authority in the form of a letter issued by the Secretary granting permission to an employer to perform preliminary screening of job applicants for a controlled dangerous substance. (14) “License” means the authority in the form of a permit issued by the Secretary granting permission for a laboratory to perform job-related alcohol or controlled dangerous substances testing. (15) “Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing who is either employed or under contract to an employer that performs preliminary screening of job applicants for a controlled dangerous substance. (16) “Non-negative test result” means the result of a preliminary screening for a controlled dangerous substance that is not negative but that has not been confirmed by a licensed laboratory. (17) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. (18) “Operator” means an individual employed by the employer or agent of the employer who performs a preliminary screening procedure as defined in §B(19) of this regulation. (19) “Preliminary screening procedure” means a controlled dangerous substance test: (a) Using a single-use test device for forensic testing; and (b) Performed by an employer or agent of the employer on a job applicant. (20) “Secretary” means the Secretary of Health or the Secretary's designee. (21) “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. (22) Specimen. (a) “Specimen” means material derived from the human body and intended for laboratory testing. (b) “Specimen” is limited to blood, urine, saliva, and hair. #### Regulation .04 Responsibilities of the Secretary. *COMAR 10.10.10.04* A. Registration. (1) Requirement. The OHCQ shall register on the Secretary's behalf an employer that conducts a preliminary screening procedure on a job applicant for a controlled dangerous substance. (2) Forms. The OHCQ shall provide to each employer: (a) A registration application form; and (b) A registration renewal form every 2 years after the initial registration. B. Routine Surveys and Complaint Investigation. (1) Requirement. The Secretary or the OHCQ as the Secretary's designee shall: (a) Conduct routine surveys of preliminary screening sites; (b) Conduct surveys of preliminary screening sites as part of a complaint investigation; and (c) Investigate written complaints related to compliance with the standards set forth in this chapter. (2) On-site Surveys. The OHCQ may: (a) Annually conduct routine on-site surveys of preliminary screening sites; (b) Conduct a routine survey any time during a preliminary screening site's normal work hours; and (c) Include as part of a routine survey or complaint investigation: (i) On-site observation and examination of preliminary screening facilities, equipment, screening devices, specimens, and screening procedures; (ii) On-site examination of documents pertinent to employer registration, preliminary screening performed by the employer or agent of the employer, and operator training; and (iii) On-site interviews of employers and employees involved in performing, supervising, or managing preliminary screening. (3) Sanctions. (a) Imposition. If the Secretary finds that an employer or agent of an employer is not in compliance with a requirement or standard of this chapter, the Secretary may impose one or more of the following sanctions on the employer, agent of the employer, or both: (i) Suspension of a letter or letters of registration; (ii) Revocation of a letter or letters of registration; (iii) A direct plan of correction; (iv) A limitation on preliminary screening; and (v) Required training and technical assistance. (b) Departmental Actions. The Secretary shall carry out actions related to the imposition or lifting of sanctions involving preliminary screenings in the same manner as those involving a laboratory, as set forth in COMAR 10.10.08, including the providing of notice and hearings. #### Regulation .05 Employer Requirements. *COMAR 10.10.10.05* An employer who for job-related reasons requires an individual to be tested for alcohol or controlled dangerous substances shall: A. Have the specimen tested by a laboratory that holds a Maryland license in the discipline of job-related alcohol and controlled dangerous substances testing; and B. At the time of testing and at the individual's request, inform the person of the name and address of the laboratory that will test the specimen. #### Regulation .06 Permissible Specimens. *COMAR 10.10.10.06* A. General. An employer requiring job-related alcohol or controlled dangerous substances testing shall require that: (1) A job applicant provide only one or more of the following types of specimen: (a) Blood; (b) Urine; (c) Saliva; and (d) Hair; and (2) An employee or contractor provide only one or more of the following types of specimen: (a) Blood; (b) Saliva; and (c) Urine. B. Specimen Types. An employer requiring job-related alcohol or controlled dangerous substances testing may not require the testing of any specimen other than: (1) Blood, urine, saliva, or hair, for a job applicant; and (2) Blood, saliva, or urine, for an employee or contractor. C. Hair. An employer may require that a job applicant submit a hair specimen for controlled dangerous substances testing if the hair specimen is: (1) Less than or equal to 1-1/2 inches in length measured from the human body; (2) Tested only for preemployment purposes; and (3) Not used for a purpose other than controlled dangerous substances testing. #### Regulation .07 Specimen Collection and Handling Procedures. *COMAR 10.10.10.07* A. Chain of Custody. A person collecting a specimen shall employ quality assurance and chain-of-custody procedures that include: (1) Collecting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; (2) Collecting, handling, storing, and shipping a specimen in a manner that: (a) Maintains its identity, confidentiality, and physical integrity; and (b) Precludes specimen contamination or adulteration; and (3) Documenting each time a person accesses or transfers the specimen. B. Specimen Quantity. A person collecting a specimen shall collect a quantity sufficient to perform an initial screening test, a confirmation test, and an independent test. #### Regulation .08 Protections for Job Applicants, Employees, and Contractors. *COMAR 10.10.10.08* A. Notice of Positive Test Results. (1) An employer who requires a job applicant, employee, or contractor to be tested for job-related reasons for the use or abuse of a controlled dangerous substance or alcohol and who receives notice that a job applicant, employee, or contractor has tested positive for a controlled dangerous substance or alcohol shall provide to the job applicant, employee, or contractor with a confirmed positive test result: (a) A copy of the laboratory test indicating the test results; (b) A copy or written summary of the employer's policy covering an employee, contractor, or job applicant with a confirmed positive test result; (c) If applicable, written notice of the employer's intent to take disciplinary action, terminate employment, or change the conditions of continued employment; and (d) A statement or copy of the provisions set forth in §B of this regulation permitting a job applicant, employee, or contractor to request independent testing of the same sample for verification of the test result. (2) The employer shall deliver the information required to be provided under §A of this regulation to the job applicant, employee, or contractor: (a) Either in person or by certified mail; and (b) Within 7 days from the date confirmed positive test results are received by the employer. B. Right to an Independent Test. (1) Challenge. A job applicant, employee, or contractor who is required to submit to job-related alcohol or controlled dangerous substances testing may request that an independent test be performed on the same specimen in a confirmation test by: (a) Notifying the employer and the laboratory that performed the confirmation test of the challenge to that test result; and (b) Requesting that laboratory to submit a sufficient portion of the original specimen to a different laboratory chosen by the job applicant, employee, or contractor and licensed by the Secretary to perform alcohol or controlled dangerous substances testing. (2) Testing Sensitivity. The job applicant, employee, or contractor shall employ as an independent testing laboratory one that will perform the independent test using detection levels for alcohol or controlled dangerous substances equal to or lower than those provided by the laboratory that performed the initial confirmation test. (3) Costs. The job applicant, employee, or contractor shall pay all costs of independent testing including any costs associated with specimen handling and transport. #### Regulation .09 Confidentiality. *COMAR 10.10.10.09* A. General. Except as otherwise provided in an employer's written drug testing policy, in this regulation, or in Health-General Article, §17-214, Annotated Code of Maryland, all information, interviews, reports, statements, memoranda, and test results received or produced as a result of job-related alcohol or controlled dangerous substances testing are confidential and may be released only under a lawful subpoena, court order, or a release signed by the individual tested, or, in the case of a minor, by the individual's parent or legal guardian. B. Nonprescription and Medically Prescribed Drugs. In the course of obtaining information for, or as a result of, conducting job-related alcohol or controlled dangerous substances testing for an employer, a laboratory, a physician, including a physician retained by the employer, or any other person, may not reveal to the employer information regarding the use of a: (1) Nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or (2) Medically prescribed drug, unless the individual being tested is unable to establish that the drug was medically prescribed under the laws of the State. #### Regulation .10 Preliminary Screening by an Employer or Agent of the Employer. *COMAR 10.10.10.10* A. In addition to any other applicable requirements in this chapter, an employer or agent of the employer that performs a preliminary preemployment screening procedure for a controlled dangerous substance on a job applicant shall meet the standards set forth in this regulation. B. Registration Requirement. An employer or agent of the employer shall register the employer initially and every 2 years thereafter with the OHCQ by: (1) Submitting to the OHCQ a registration form that: (a) Lists the permanent office location of the employer and any agent of the employer in the State; (b) Lists the permanent locations where the employer or agent of the employer performs preliminary screenings; and (c) States whether the employer or agent of the employer performs preliminary screenings at temporary sites, uses mobile screening vehicles, or both; and (2) Submitting to the OHCQ a registration fee of $50. C. Single-Use Test Device. An employer or agent of the employer shall limit screening procedures to those that employ an FDA-cleared or approved single-use test device as defined in Regulation .03B(21) of this chapter. D. Trained Operator. To perform a preliminary screening procedure, an employer or agent of the employer shall employ an operator who has been trained for each type of device to be used, including instruction that includes the operator's: (1) Reading the test manufacturer's package insert sheet; (2) Observing the test manufacturer's training video or receiving training: (a) From the test manufacturer; (b) From an individual trained by the manufacturer; or (c) Endorsed by the manufacturer; (3) Completing the test manufacturer's self-administered test; and (4) Performing tests, interpreting test results, and reporting results to job applicants under the supervision of a trained operator. E. Training Records. (1) Requirement. An employer or agent of the employer shall establish and maintain training records that document the training required to properly perform a screening procedure. (2) Documentation. An employer or agent of the employer shall: (a) Keep a record of the training received by a trainee; (b) Document that a trainee has demonstrated competency in performing the screening procedure; and (c) Maintain for at least 2 years documentation that the trainee has been trained as set forth in this regulation. F. Quality Assurance. An employer or agent of the employer shall: (1) Limit screening procedures to those that employ an FDA-cleared or FDA-approved single-use test device for forensic testing, as defined in Regulation .03 of this chapter; (2) Perform preliminary screening tests in accordance with the quality standards set forth in COMAR 10.10.03.02C(2) and (3); (3) Collect and handle all specimens and ship non-negative specimens for testing, in a manner that: (a) Maintains the specimen donor's identity and confidentiality; and (b) Precludes contamination of and tampering with the specimen; (4) Provide a secure area with limited access to store a non-negative specimen before it is shipped to a laboratory and while it is retained pending: (a) Confirmatory testing; (b) Notice; (c) Any independent testing; and (d) Final disposal; (5) Submit a non-negative specimen subjected to a preliminary screening procedure to a licensed medical laboratory for confirmatory testing within 24 hours of screening; (6) Maintain a written record of the chain-of-custody for a specimen from the time it is collected until it is no longer needed for retesting or confirmatory testing; (7) Have a medical review officer, as defined in Regulation .03B(15) of this chapter, review positive test results resulting from a confirmatory test; and (8) Retain for at least 1 year all records pertaining to preliminary screening. G. Notice and Independent Testing. An employer or agent of the employer who receives notice that a job applicant has tested positive for a controlled dangerous substance shall: (1) Provide to the job applicant the items specified in Regulation .08A of this chapter; and (2) Inform the job applicant of the right to request that an independent test be performed on the same specimen, as set forth in Regulation .08B of this chapter. H. Voluntary Disclosure. (1) For the purposes of facilitating hiring, a job applicant may voluntarily disclose and provide documentation to an operator that the job applicant is using: (a) A nonprescription drug that is not prohibited under the laws of the State; (b) A medically prescribed drug; or (c) Both. (2) An operator may disclose to the employer information involving the use of medically prescribed and nonprohibited nonprescription drugs voluntarily disclosed and documented to the operator by the job applicant. I. Surveys and Complaint Investigations. An employer or agent of an employer shall permit the OHCQ to conduct an on-site survey of a preliminary screening site at any time during the screening site's normal hours of operation as part of a complaint investigation or routine inspection to determine compliance with the applicable requirements and standards set forth in this chapter. ### Chapter 11 — Biological Agents Registry Program **Authority:** Health-General Article, §§17-601—17-605, Annotated Code of Maryland **Administrative History:** Effective date: November 25, 2002 (29:23 Md. R. 1811) **Administrative History:** Chapter revised effective July 31, 2006 (33:15 Md. R. 1280) **Administrative History:** Chapter revised effective January 23, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .07F amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .11A amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .12B, C amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .14 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 517) #### Regulation .01 Purpose. *COMAR 10.10.11.01* The purpose of this chapter is to help protect the people of Maryland against the potential threat of biological terrorism by establishing a program to register persons that possess, maintain, transfer, or receive biological agents in the State. #### Regulation .02 Scope. *COMAR 10.10.11.02* A. This chapter contains the standards and requirements a person that possesses, maintains, transfers, or receives a biological agent in this State shall meet to comply with the registration of biological agents. B. This chapter does not apply to a biological agent or a certified laboratory or facility that is exempt from the requirements for the interstate shipment of etiologic agents under 42 CFR §§73.5 and 73.6, 9 CFR §§121.5 and 121.6, and 7 CFR §331.5. #### Regulation .03 Definitions. *COMAR 10.10.11.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Access” means the ability or the means necessary to: (a) Read, write, modify, or communicate BAR information; or (b) Otherwise make use of any system resource related to BAR information. (2) “Access control” means a method of restricting access to a BAR information resource, allowing only an authorized individual access to the resource. (3) “Authentication” means the corroboration that a person is the one claimed. (4) “BAR” means the Department’s Biological Agents Registry. (5) BAR Information. (a) “BAR information” means information submitted to the BAR Program by a person required to report a biological agent under this chapter. (b) “BAR information” identifies: (i) A person in this State who possesses, maintains, transfers, or receives a biological agent; and (ii) The biological agents possessed, maintained, transferred, and received by a person in this State. (c) “BAR information” includes: (i) Information contained in any of the documents and records that the BAR Program collects, requests, maintains, processes, or stores; (ii) Information released by the BAR Program, a trusted partner, or a BAR information custodian; and (iii) Biological agent incident response plans submitted to a local jurisdiction as required by this chapter. (6) BAR Information Custodian. (a) “BAR information custodian” means an individual designated by a trusted partner and authorized by the Department in a trusted partner agreement to receive and maintain BAR information. (b) “BAR information custodian” may include: (i) A health officer or designee; (ii) An Emergency Management Director or designee; and (iii) Other alternately designated and authorized individuals with a legitimate need to know the BAR information as it relates to the performance of the person's duties. (7) “BAR Program” means the Department’s BAR Program within the Laboratories Administration’s Office of Laboratory Emergency Preparedness and Response. (8) “Biological agent” means: (a) A select agent or toxin listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4; (b) A genetically modified microorganism or genetic element from an organism listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4, shown to produce or encode for a factor associated with disease; or (c) A genetically modified microorganism or genetic element that contains nucleic acid sequences coding for a toxin listed in 42 CFR §§73.3 and 73.4, and 9 CFR §§121.3 and 121.4, or the toxin's subunits. (9) Biological Agent Incident. (a) “Biological agent incident” means a breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to an individual's health and safety. (b) “Biological agent incident” includes any situation that may cause or potentially cause an exposure to or release of a biological agent, as set forth in Regulation .12B of this chapter. (10) “Biosafety Level (BSL)” means the level of work practices, facility design, and safety equipment to prevent transmission of biologic agents to workers, other individuals, and the environment, as defined in the BMBL. (11) “Biosafety Level-2 (BSL-2)” means the BSL used when: (a) Work is done with biological agents associated with human disease; and (b) The route of transmission is by: (i) Percutaneous injury; (ii) Ingestion; or (iii) Mucous membrane exposure. (12) “Biosafety Level-3 (BSL-3)” means the BSL used when: (a) Work is done with indigenous or exotic agents associated with a potentially serious or lethal human disease; and (b) The route of transmission is aerosol inhalation. (13) Biosafety Level-4 (BSL-4). (a) “BSL-4” means the BSL used when work is done with a dangerous and exotic biological agent that poses a high risk of life-threatening or lethal human disease that: (i) May be transmitted via the aerosol route; (ii) Has an unknown mode of transmission; or (iii) Has no available vaccine or therapy. (b) “BSL-4” includes the BSL used when the agent has a close or identical antigenic relationship to BSL-4 agents. (14) “BMBL” means the “Biosafety in Microbiological and Biomedical Laboratories”, which is incorporated by reference in Regulation .04 of this chapter. (15) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services. (16) “Compact Disc-Recordable (CD-R)” means a type of write once, read many compact disc format that allows one-time recording of digital information on the disc. (17) Contingency Plan. (a) “Contingency plan” means a plan for responding to an information system emergency. (b) “Contingency plan” includes: (i) Installing system information from backups; (ii) Preparing critical facilities that can be used to facilitate continuity of operations in the event of an emergency; and (iii) Recovering from a disaster. (18) “Decryption” means reversing the protective encryption algorithm process to make the previously unintelligible plaintext available for further processing as intelligible plaintext. (19) “Deficiency” means a documented lack of compliance with a standard or requirement of the BAR Program set forth in this chapter. (20) “Department” means the Maryland Department of Health. (21) “Emergency management director” means an individual appointed by the Governor of Maryland, who is directly responsible for the organization, administration, and operation of the local organization for emergency management in the local jurisdiction as set forth in Public Safety Article, §14-109, Annotated Code of Maryland. (22) Encryption. (a) “Encryption” means transforming confidential plaintext into ciphertext to protect it so that the data can be securely stored. (b) “Encryption” includes encrypting with an algorithm that combines plaintext with other values called keys, or ciphers, so the data becomes unintelligible. (23) “Etiologic” means disease causing. (24) “Exposure” means the condition of being subjected to a biological agent which may have a harmful effect. (25) “Facility” means a building or complex of buildings owned by the same person and located at a single mailing address. (26) “Genetic element” means a nucleic acid sequence shown to produce or encode for a factor associated with a disease, a toxin, or a toxin's subunits. (27) “Local jurisdiction” means a county of the State or Baltimore City. (28) “Maintaining a biological agent” means manipulating or holding a biological agent to sustain or enhance viability, infectivity, or toxicity. (29) “Maryland Institute for Emergency Medical Services Systems (MIEMSS)” means the unit established by Education Article, §13-503, Annotated Code of Maryland. (30) “MDE” means the Maryland Department of the Environment. (31) “MEMA” means the Maryland Emergency Management Agency. (32) Nature of a Biological Agent. (a) “Nature of a biological agent” means the term that describes the kind or type of material or organism the agent is. (b) “Nature of a biological agent” includes: (i) Toxin; (ii) Bacterium; (iii) Virus; (iv) Rickettsia; (v) Fungus; (vi) Allergen; (vii) Genetic element; or (viii) Any combination of §B(32)(b)(i)—(vii) of this regulation. (c) “Nature of a biological agent” does not include the name or identity of the biological agent. (33) Person. (a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (b) “Person” includes State and federal units of government. (34) “Personal identification number (PIN)” means a number or code assigned to an individual and used to provide verification of identity. (35) “Personal protective equipment (PPE)” means the type of physical barrier equipment necessary to: (a) Protect an individual from contact with a biological agent; or (b) Prevent transmission of a biological agent. (36) “Possessing a biological agent” means handling, holding, maintaining, owning, or storing a biological agent within the State. (37) Responsible Official. (a) “Responsible official” means an individual designated by a person required to report under this chapter to act on the person's behalf. (b) “Responsible official” includes an individual designated as an alternate responsible official who acts in the responsible official's absence. (38) “Role-based access” means a security mechanism for granting user access to a computer information system containing BAR information, based upon the user's job function. (39) “Secretary” means the Secretary of Health. (40) “Security incident” means a situation when BAR information is: (a) Intentionally or unintentionally released to an unauthorized person; or (b) Otherwise compromised in a way that allows unauthorized access. (41) Security Self-Assessment. (a) “Security self-assessment” means a person's formal assessment of the sensitivity, vulnerabilities, and security of the person's operations and programs related to the BAR information the person receives, manipulates, stores, or transmits. (b) “Security self-assessment” includes the: (i) Procedures and processes for determining a person's compliance with the BAR information security standards in this chapter; (ii) Documentation certifying to the BAR Program that a person meets the BAR information security standards; (iii) Identification and management of security risks; and (iv) Security standards self-assessment check list provided by the BAR Program. (42) “Technical security measure” means a process that is put in place to protect information and control individual access to information in order to guard data integrity, confidentiality, and availability. (43) “Token” means an electronic device for authenticating user identification and allowing access to a door or computer information system. (44) Toxin. (a) “Toxin” means a biologically active poisonous substance that is: (i) Produced by a living cell or an organism; and (ii) Harmful to another organism. (b) “Toxin” does not include: (i) A poisonous substance produced by a living organism for medical purposes, inactivated for use as a vaccine; or (ii) A toxin preparation for biomedical research use at a lethal dose of 50 percent (LD50) for vertebrates of more than 100 nanograms per kilogram body weight. (45) “Transfer” means the physical relocation of a biological agent from one facility or person to another. (46) Trusted Partner. (a) “Trusted partner” means a person with whom the Department has a valid trusted partner agreement to receive, possess, maintain, and transfer or share BAR information, as set forth in this chapter. (b) “Trusted partner” includes only MDE, MEMA, MIEMSS, and a local jurisdiction where a biological agent is located. (47) Trusted Partner Agreement. (a) “Trusted partner agreement” means a document describing the arrangement between the Department and a trusted partner regarding how, when, and to whom information is released from the BAR. (b) “Trusted partner agreement” includes the documentation that describes all the policies, procedures, and mechanisms agreed upon to protect the integrity, confidentiality, and availability of BAR information. (48) “User-based access” means a security mechanism used to grant system access to users, based upon the identity of the user. #### Regulation .04 Incorporation by Reference. *COMAR 10.10.11.04* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 29 CFR §1910.1450, as amended. (2) 42 CFR 73, as amended. (3) 9 CFR 121, as amended. (4) 7 CFR 331, as amended. (5) CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories”, 5th Edition, December 2009, as amended. #### Regulation .05 Registering Under the Biological Agents Registry Program. *COMAR 10.10.11.05* A person in the State shall participate in and comply with the State's BAR Program by registering with and reporting to the Department, in the manner set forth in this chapter, the information required by the Department. #### Regulation .06 Compliance with Federal Standards. *COMAR 10.10.11.06* A person that possesses, maintains, transfers, or receives a biological agent shall comply with all safeguards contained in 42 CFR 73, 9 CFR 121, and 7 CFR 331 that apply to a person registered to transfer the same agent under federal law and regulation. #### Regulation .07 Responsibilities of the Department. *COMAR 10.10.11.07* The Department shall: A. Establish and maintain a registry that identifies the biological agents possessed, maintained, transferred, and received by a person in this State; B. Conduct facility surveys by mail, by on-site visit, or both, initially and periodically after that, to: (1) Ensure compliance with the standards and requirements of the BAR Program; and (2) Address any deficiencies or complaints; C. Provide or approve the forms that a person shall complete and submit to the Department under the BAR Program; D. Issue notice when a survey of a facility yields findings of deficiencies related to the standards or requirements of the BAR Program; E. Investigate a complaint that a facility or an employee is not complying with the standards or requirements of the BAR Program; and F. Release BAR information, as provided in this chapter, to: (1) State and federal law enforcement agencies; (2) CDC; (3) Trusted partners; and (4) The Secretary or designee. #### Regulation .08 Responsible Official; Alternate Responsible Official. *COMAR 10.10.11.08* A. A person required to report to the BAR Program under this chapter shall designate an individual to be the responsible official who: (1) Is familiar with the requirements of this chapter; (2) Has the authority and responsibility to act on the person's behalf related to a biological agent; and (3) Shall ensure compliance with the requirements of this chapter. B. The responsible person shall ensure that the annual inspection and specific reporting requirements and mechanisms are carried out in accordance with 42 CFR §73.9. C. A person required to report to the BAR Program under this chapter shall: (1) Designate one or more individuals to be an alternate responsible official to act in the responsible official's absence; and (2) Ensure that the individual designated as an alternate responsible official has the authority required in §A of this regulation to ensure compliance with this chapter when acting in the responsible official's absence. #### Regulation .09 Reporting Requirements. *COMAR 10.10.11.09* A. What to Report. Using reporting forms provided or approved by the Department, a person shall: (1) Identify all non-exempt biological agents that the person possesses, maintains, transfers, or receives listed under: (a) Select agents and toxins in: (i) 42 CFR §73.3; (ii) 9 CFR §121.3; and (iii) 7 CFR §331.3; and (b) Overlap select agents and toxins in: (i) 42 CFR §73.4; and (ii) 9 CFR §121.4; (2) Indicate as part of the identification if a biological agent is: (a) Viable or nonviable; (b) Purified genomic material; (c) Recombinant DNA; (d) Used in small or large animal work; (e) Used in large-scale production; and (f) A toxin; (3) Identify the physical location of a laboratory and storage area within a facility where a biological agent is contained; (4) Identify the biosafety level required for the biological agent; and (5) Identify the individual in charge of the biological agent and information needed to contact that individual. B. When to Report. A person shall: (1) Complete and submit a report within 30 days of receiving a request to report from the Department; (2) Submit a report of each transfer and receipt of a biological agent within 24 hours of completing a transfer as set forth in Regulation .10D of this chapter; (3) Respond in writing to a deficiency notice from the Department within 10 work days of receiving the notice; and (4) Respond in writing to notice of a complaint within 10 work days of receiving notice from the Department. C. Who Submits Reports. A person shall submit a report dated and signed by the: (1) Individual who actually possesses, maintains, transfers, or receives and has charge of a biological agent; and (2) Responsible official of the facility where the biological agent is located. D. Where to Report. A person shall return all completed reports and other correspondence to the BAR Program, c/o Laboratories Administration, Maryland Department of Health. #### Regulation .10 Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent. *COMAR 10.10.11.10* A person possessing, maintaining, transferring, or receiving a biological agent at a facility located in the State shall: A. Possess a laboratory and personnel equipped and capable of handling the biological agents at BSL 2, 3, or 4, depending on the agent and the type of work being performed with the agent, as contained in the BMBL; B. Meet specific requirements for handling a toxin subject to this chapter as set forth in 29 CFR §1910.1450; C. Allow an official representative of the Department to determine compliance with the standards and requirements of this chapter by: (1) Conducting an on-site inspection of the person's facility, including all: (a) Storage areas; (b) Laboratories; and (c) Operations; and (2) Examining and reviewing procedures and documentation related to biological agents; D. Submit a copy of each completed CDC form documenting transfer or receipt of a biological agent, within 24 hours of completing a transfer or receipt, to the BAR Program; and E. Inform the Emergency Management Director or designee and health officer or designee in the local jurisdiction where the biological agent is located of the nature and facility location of each reported biological agent that is located in that jurisdiction. #### Regulation .11 Reporting of Unauthorized Activities. *COMAR 10.10.11.11* On learning that there is an unauthorized activity involving a biological agent, including the unauthorized possession, unauthorized attempted possession, unauthorized maintenance, unauthorized transfer, or unauthorized receipt of a biological agent, a person shall immediately alert the Department by: A. Telephoning the: (1) Laboratories Administration at 443-681-3787 or 410-925-3121 between 8 a.m. and 4:30 p.m. weekdays; or (2) Department's emergency after-hours and weekend telephone line at 410-795-7365 at other times; B. Asking the individual taking the call to direct the information being reported to the BAR Program or the Director of the Laboratories Administration; and C. Reporting details about the unauthorized activity set forth in this regulation, such as: (1) The location of a facility and laboratory involved; (2) The identity of a person possessing or attempting to possess a biological agent; and (3) Other details pertinent to the report. #### Regulation .12 Biological Agent Incident Response Plan. *COMAR 10.10.11.12* A. Requirement. A person required to report under this chapter shall: (1) Develop, implement, and maintain a written biological agent incident response plan; (2) Review the plan annually and revise the plan as necessary; and (3) Submit a copy of the plan and any amendments to the plan to the: (a) Emergency management director in the local jurisdiction where the biological agent is located; and (b) BAR Program. B. A person required to submit a biological agent incident response plan shall: (1) Coordinate the biological agent incident response plan with any facility-wide plans; (2) Keep the biological agent incident response plan current to reflect actual procedures and practices; (3) Locate and maintain the biological agent incident response plan in the workplace; (4) Make the biological agent incident response plan available to employees; (5) Ensure that the biological agent incident response plan fully describes the response procedures for: (a) The theft, loss, or release of a biological agent; (b) Inventory discrepancies; (c) Security breaches, including in computer information systems; (d) Severe weather and other natural disasters; (e) Workplace violence; (f) Bomb threats; (g) Suspicious packages; (h) Emergencies such as: (i) Fire; (ii) Gas leaks; (iii) Explosions; and (iv) Power outages; (i) Use of PPE; (j) Use of onsite emergency equipment to protect both the facility and personnel; (k) Employees to follow when performing: (i) Rescue or medical duties; (ii) Emergency medical treatment; and (iii) First aid; (l) Emergency evacuation, including: (i) Type of evacuation; (ii) Exit route assignments; (iii) Safe distances; and (iv) Places of refuge; (m) Decontamination; and (n) Site security and control; (6) Ensure that the plan includes procedures that explain the: (a) Risks and hazards associated with any biological agent on the premises; and (b) Actions to contain the biological agent; (7) Ensure that the plan contains the following information: (a) The name and contact information for home, work, and emergencies, for the: (i) Responsible official; and (ii) Alternate responsible official; (b) Where applicable, the name and contact information for: (i) The building owner and manager; (ii) Tenants; and (iii) The official in charge of the building's physical security; (c) Personnel roles and lines of authority and communication; (d) Planning and coordination with local emergency responders; and (e) A list of the PPE available and where the PPE is located in the facility; (8) Conduct drills or exercises at least annually to test and evaluate the effectiveness of the plan; (9) Notify the Emergency Management Director in the local jurisdiction where the biological agent is located and the BAR Program before a drill or exercise is conducted; (10) Notify the Emergency Management Director and the health officer in the local jurisdiction where the biological agent is located and the BAR Program immediately following a biological agent incident involving exposure or potential exposure as set forth in COMAR 10.06.01.03A; (11) Prepare a report of the results of a drill, exercise, or biological agent incident; (12) Review a report of the results of a drill, exercise, or biological incident to determine if the plan requires revision; and (13) Within 10 days after a drill, exercise, or biological agent incident, submit a copy of the report to the: (a) Emergency management director in the local jurisdiction where the biological agent is located; and (b) BAR Program. C. Monitoring Compliance. When a person submits a biological agent incident response plan to the BAR Program, the BAR Program shall verify that the person submitting the plan has provided the information for planning and coordinating with local emergency responders to the Emergency Management Director in the local jurisdiction where the biological agent is located. #### Regulation .13 BAR Information Confidentiality and Release of BAR Information. *COMAR 10.10.11.13* A. Except as otherwise provided in this chapter, a person shall keep information prepared for or maintained in the BAR, including biological agent incident response plans required by Regulation .12 of this chapter: (1) Confidential; and (2) Protected from unauthorized access and use. B. BAR information is not subject to State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland. C. Release or sharing of BAR information as authorized in this chapter does not render the BAR information released or shared a public record. D. Except as provided in §§G—I of this regulation, a person to whom BAR information has been released may not release the information to another person unless the release is approved by the BAR Program. E. The BAR Program may release BAR information only to: (1) State and federal law enforcement agencies; (2) CDC; (3) BAR information custodians of trusted partners; (4) The Secretary or designee; and (5) The health officer of any affected jurisdiction. F. Before the BAR Program releases BAR information to a person, except State and federal law enforcement agencies, the CDC, and the Department, the person shall: (1) Enter into and maintain a trusted partner agreement; (2) Conduct a BAR information security self-assessment; and (3) Submit the results of a BAR information security self-assessment to the BAR Program for approval. G. Mutual Aid Response. When multiple local jurisdictions respond to an emergency or biological agent incident, the Emergency Management Director of one responding jurisdiction may share BAR information with an Emergency Management Director from another local jurisdiction, and the health officer of one jurisdiction may share BAR information with the health officer of another jurisdiction that is providing mutual aid by assisting with the emergency response. H. Emergency Release Activation Process. (1) A trusted partner may release on an emergency basis BAR information about the nature and location of a biological agent to another trusted partner or emergency public safety personnel when: (a) An on-site alarm goes off at a person's facility where a biological agent is located and an individual at the site is required to place a telephone call to a 9-1-1 center; (b) A 9-1-1 center dispatches emergency public safety personnel to a site where a biological agent is known to be located; or (c) There is a reported breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to the health and safety of the public or emergency public safety first responders. (2) MIEMSS may release on an emergency basis the nature and location of a biological agent to a: (a) Police officer, as defined in Public Safety Article, §3-201(e), Annotated Code of Maryland, who is responding to an emergency; and (b) Fire, rescue, or emergency medical services entity, as defined in Public Safety Article, §7-101, Annotated Code of Maryland, when responding to an emergency. I. 24/7 Access to BAR Information. (1) MDE, MEMA, and MIEMSS may act as a back-up to the BAR Program by maintaining: (a) 24/7 (24 hours a day, 7 days a week) access to BAR information; and (b) Access to BAR information when a trusted partner does not have access to BAR information. (2) MDE, MEMA, or MIEMSS may release BAR information regarding the nature and location of a biological agent to each other or another BAR Program trusted partner if the trusted partner is unable to obtain access to BAR information. J. Emergency Release of Name or Identity of a Biological Agent. MDE, MEMA, or MIEMSS may release by any necessary means of communication the name or identity of the specific biological agent located at the site of an emergency response to protect the health and safety of the public and emergency response personnel if: (1) There is: (a) A breach in containment of a biological agent; (b) An imminent threat of a breach of containment; or (c) An exposure or potential exposure; (2) The breach or imminent threat of a breach, exposure, or potential exposure is confirmed by the: (a) Responsible official; or (b) Emergency public safety personnel at the scene of the emergency response; (c) Occupational Health; and (3) The release is approved by the Department's physician on-call. K. Departmental Authorization to Release Name or Identity of Biological Agent. (1) The Department's physician on-call may release the name or identity of a biological agent as required to mitigate the risk and treat those exposed based on the potential threat to the health and safety of the public. (2) The Department's physician on-call shall decide when, how, and to whom to release the name or identity of the biological agent. L. Notification Protocol. (1) When there is a breach or imminent threat of a breach in containment of a biological agent, exposure, or potential exposure as described in §J of this regulation, the: (a) Responsible official or other designated person shall immediately notify the Emergency Management Director and health officer of any affected jurisdiction; (b) Public safety personnel responding to an emergency shall contact the public safety personnel's 9-1-1 center; and (c) 9-1-1 center personnel shall notify MIEMSS and each of the following individuals in the jurisdiction where the breach, exposure, or potential exposure occurred: (i) The Emergency Management Director; and (ii) The health officer. (2) When MIEMSS receives notice of a breach or an imminent threat of a breach of containment of a biological agent, exposure, or potential exposure, MIEMSS shall notify: (a) The Department's: (i) Physician on-call; and (ii) BAR Program within the Office of Laboratory Emergency Preparedness and Response; (b) MDE; (c) MEMA;and (d) The health officer of any affected jurisdiction. (3) Immediately after the health officer is notified by 9-1-1 center personnel, the health officer shall contact the Department’s physician on-call to: (a) Verify the BAR information release; and (b) Confirm a plan of action regarding: (i) Release of BAR information; and (ii) Measures to be taken to protect the health and safety of the public. M. Using a form provided by the BAR Program, a trusted partner shall notify the BAR Program within 72 hours after the: (1) Trusted partner's BAR information custodian releases or shares BAR information; or (2) Trusted partner releases or shares BAR information with another trusted partner. #### Regulation .14 Method of Non-Emergency Release of BAR Information. *COMAR 10.10.11.14* A. A person shall release and transfer BAR information to a trusted partner and a BAR information custodian in a secure manner, which includes the use of: (1) Read-only optical or electronic media; (2) Encryption, decryption, passwords, and firewalls; (3) Copy protection to prevent unauthorized copying or duplication. (4) A telephone; (5) Voice mail; (6) An electronic or mechanical recording device; and (7) An internet communication system, such as voice-over-internet-protocol (VoIP). B. The BAR Program shall release BAR information to a BAR information custodian of a local jurisdiction, MDE, MEMA, and MIEMSS: (1) When notified by the BAR Program that the BAR information is available for release; and (2) On weekdays between the hours of 8:30 a.m. and 3:30 p.m. C. BAR Program staff shall document the release of all BAR information to trusted partners in a permanent record that contains the: (1) Name of the BAR information custodian; (2) Identity of the trusted partner; (3) Means of release of BAR information, including but not limited to: (a) Encrypted email; and (b) CD-R; and (4) Date and time of the release or delivery of the BAR information. #### Regulation .15 Release of BAR Information to Law Enforcement Agencies and CDC. *COMAR 10.10.11.15* The BAR Program may release BAR information to State and federal law enforcement agencies and the CDC without a trusted partner agreement if the release of BAR information is pursuant to: A. A communicable disease investigation commenced or conducted by: (1) The Department; or (2) A State or federal law enforcement agency having investigative authority; or B. An investigation involving a release, theft, or loss of a biological agent. #### Regulation .16 Release of BAR Information to Local Jurisdictions. *COMAR 10.10.11.16* A. The Department shall release to a local jurisdiction the BAR information listed in §C of this regulation for each biological agent located within the local jurisdiction, if the local jurisdiction: (1) Enters into and maintains a trusted partner agreement with the Department; and (2) Limits the number of BAR information custodians in the local jurisdiction to the: (a) Health officer or the health officer’s designee; and (b) Emergency management director or the emergency management director’s designee. B. The local jurisdiction may use the BAR information for: (1) Protecting emergency first-responders, including: (a) Fire fighters; (b) Police officers; and (c) Emergency employees, including: (i) Emergency medical personnel; (ii) Rescue workers; and (iii) Public health emergency responders; (2) Planning for emergency protection of the public related to the: (a) Release of a biological agent; or (b) Prevention of a release of a biological agent; and (3) Conducting investigations related to biological agents. C. Information Released. The BAR Program shall inform the BAR information custodian in the local jurisdiction of the: (1) Location in the local jurisdiction of the biological agent, including the: (a) Facility or entity name; and (b) Physical address of the facility; (2) Nature of each biological agent; and (3) The BSL or PPE necessary to protect emergency responders from contact with or transmission of the biological agent. #### Regulation .17 Release of BAR Information to MDE, MEMA, and MIEMSS. *COMAR 10.10.11.17* The Department shall: A. Release separately to the BAR information custodians of MDE, MEMA, and MIEMSS the BAR information listed in §C of this regulation for each biological agent located within the State, if MDE, MEMA, and MIEMSS each separately becomes a trusted partner by: (1) Entering and maintaining a trusted partner agreement with the Department; and (2) Authorizing and identifying the individual who is the designated BAR information custodian in the trusted partner agreement; B. Make BAR information available to MDE, MEMA, and MIEMSS for the purpose of planning for the protection of the public related to the: (1) Release of a biological agent, such as a breach in containment; (2) Prevention of a release of a biological agent; and (3) Mitigation and planning for the protection of: (a) Critical infrastructure; (b) Key assets; and (c) Emergency public safety personnel; and C. Provide the following BAR information of each biological agent in the State that is registered under this chapter to the BAR information custodian of MDE, MEMA, and MIEMSS, including for the entity that possesses, maintains, transfers, or receives a biological agent: (1) Name and contact information of: (a) The responsible official; (b) The alternate responsible official; and (c) Other personnel or staff listed by the facility who are responsible for a biological agent; (2) Location of the biological agent, including the: (a) Facility or entity name; and (b) Physical address of the facility; (3) Name or identity of each biological agent; (4) Nature of each biological agent; (5) BSL necessary to handle safely and contain the biological agent; and (6) PPE necessary to protect emergency responders from contact with or transmission of the biological agent. #### Regulation .18 BAR Information Updates. *COMAR 10.10.11.18* The Department shall provide updated BAR information to the BAR information custodians of all trusted partners authorized under this chapter: A. Within 30 days when there is an: (1) Upward change in the BSL at a listed person's facility, for example from BSL-3 to BSL-4; or (2) Addition to the BAR, including a new: (a) Person possessing or maintaining a biological agent; (b) Facility where a biological agent is located; or (c) Biological agent; and B. At least once each year. #### Regulation .19 BAR Information Security Standards — General. *COMAR 10.10.11.19* A. A trusted partner shall protect and maintain BAR information in a secure manner by limiting access only to a BAR information custodian who is: (1) An individual designated by the trusted partner; and (2) Authorized by the Department in a trusted partner agreement. B. Before the Department shares BAR information with a trusted partner, the trusted partner shall: (1) Develop, implement, and maintain administrative, physical, and technical security measures and practices to protect and safeguard the integrity, confidentiality, and availability of BAR information by managing and supervising the: (a) Selection, execution, and use of security measures to protect BAR information; and (b) Conduct of personnel in relation to the protection of BAR information; (2) Assess potential risks and vulnerabilities to the BAR information in its possession using a BAR information security self-assessment checklist provided by the BAR Program; and (3) Submit a: (a) Completed BAR information security self-assessment; and (b) Document verifying that the trusted partner's BAR information custodian has successfully undergone a security risk assessment as described in 42 CFR §73.7. C. If a BAR information custodian believes that the security of BAR information has been or is suspected to have been misused, mishandled, lost, stolen, or otherwise compromised, the BAR information custodian shall immediately notify the: (1) BAR Program; and (2) Individuals who signed the BAR information custodian's trusted partner agreement. #### Regulation .20 BAR Information Security Standards — Administrative Procedures. *COMAR 10.10.11.20* A trusted partner shall establish and maintain administrative procedures to protect BAR information integrity, confidentiality, and availability, which include: A. Entering and maintaining with the Department a trusted partner agreement that certifies that the trusted partner shall: (1) Establish and implement the policies and procedures to carry out the requirements of this chapter; and (2) Designate a BAR information custodian; B. Establishing and implementing a contingency plan for protecting confidentiality of and access to BAR information when responding to a disaster or computer information system emergency, which includes: (1) Preparing critical facilities that can be used to facilitate continuing protection of BAR information in the event of an emergency; (2) Disaster recovery procedures to follow in the event of: (a) Fire; (b) Vandalism; (c) Natural disaster; or (d) Computer information system failure; (3) An emergency mode operation plan that includes procedures for assuring continuing protection of BAR information when the trusted partner continues to operate in the event of: (a) Fire; (b) Vandalism; (c) Natural disaster; or (d) Computer information system failure; and (4) Testing and revising procedures that document the process of periodically testing the written contingency plan procedures to determine: (a) Weaknesses; and (b) The subsequent process of revising the procedures, if necessary; C. A mechanism for the receipt, viewing, manipulation, storage, release, dissemination, and disposal of BAR information; D. Information-use policies that ensure that BAR information is used only as specified in this chapter; E. Internal audit procedures for: (1) Maintaining records of computer information system activity including: (a) Logons; (b) File accesses; and (c) Security incidents; and (2) Reviewing the records of computer information system activity for: (a) Breaches in security; and (b) Unauthorized access; F. Personnel security procedures that ensure that only personnel who have the required authorizations and agency clearances have access to BAR information by: (1) Providing oversight of unauthorized personnel when the personnel are performing their duties near BAR information, which includes: (a) Supervision of maintenance personnel by an authorized and knowledgeable individual; and (b) Assuring that unauthorized or unsupervised operating and maintenance personnel do not have and cannot acquire access to BAR information; (2) Maintaining and reviewing a record of access authorizations that documents the levels of access granted to an individual accessing BAR information; (3) Establishing personnel clearance procedures as a protective measure applied to determine that an individual's access to BAR information is permissible; and (4) Ensuring that BAR information computer information system users, including maintenance personnel, receive security awareness training; G. Employee termination procedures for ending an employee's employment or a user's access to BAR information, which includes: (1) Changing locks, lock combinations, or keypad codes when personnel knowledgeable of locks, lock combinations, or keypad codes no longer need to: (a) Know the information; or (b) Access BAR information; (2) Removal from access lists, including physical eradication of an individual's access privileges; (3) Termination or deletion of an individual's access privileges to BAR information for which the individual currently has authorization and need-to-know access when the authorization and need-to-know access no longer exists; and (4) Returning to the trusted partner any access devices, such as: (a) Keys; (b) Tokens; (c) Badges; or (d) Cards; and H. Training for all personnel concerning the vulnerabilities of the BAR information and ways to ensure the protection of BAR information, which include: (1) Awareness training including: (a) Password maintenance; (b) Security incident reporting; and (c) Viruses and other forms of malicious software; (2) Periodic security reminders of security concerns; and (3) User education in: (a) What to do if a virus is detected; (b) Monitoring logon success or failure; (c) How to report discrepancies; and (d) Password management, including the: (i) Rules to be followed in creating and changing passwords; and (ii) Need to keep passwords confidential. #### Regulation .21 BAR Information Security — Physical Safeguards. *COMAR 10.10.11.21* A trusted partner shall establish physical safeguards to guard BAR information integrity, confidentiality, and availability, which include: A. Physical protection of the personal computer system used for viewing BAR information and related buildings and equipment from: (1) Fire; (2) Natural and environmental hazards; (3) Disasters; and (4) Intrusion; B. A secure work station location with physical safeguards to eliminate or minimize the possibility of unauthorized access to BAR information, including: (1) Locating a personal computer used to access and view BAR information in a locked room; (2) Restricting access to the locked room to authorized personnel by using: (a) Electronic keypads; (b) Electronic access badges; or (c) Door locks; (3) Placing the computer monitor in a way that screen contents are not viewable by an unauthorized person; (4) Locking file cabinets, desks, and desk drawers that contain BAR information: (a) During nonworking hours; and (b) When the BAR information custodian is not present in the immediate area; and (5) Making BAR information nonviewable or unobtainable before admitting an unauthorized person into the workspace; C. BAR information media control procedures that govern the receipt, removal, and disposal of BAR information CD-R discs or thumb drives into or out of the facility, which include: (1) Access control so that only the BAR information custodian can receive the BAR information media; (2) Accountability procedures that trace the receipt, removal, and disposal of BAR information media; (3) BAR information storage; and (4) Tracking the disposal process and the final disposition of: (a) Electronic BAR information; and (b) BAR information hardware on which electronic BAR information is stored; D. Emergency mode operation access controls that enable continuing protection to BAR information in the event of: (1) Fire; (2) Vandalism; (3) Natural disaster; or (4) BAR information computer information system failure; E. A facility security plan to safeguard BAR information on the premises from unauthorized physical access, tampering, and theft; F. Verifying access authorizations before granting physical access; G. Maintaining documentation of repairs and modifications to the physical components of the facility including: (1) Hardware; (2) Walls; (3) Doors; and (4) Locks; and H. Procedures governing the reception and hosting of visitors, including: (1) Sign-in logs for visitors; and (2) Providing escorts for visitors, if appropriate. #### Regulation .22 BAR Information Security — Technical Security Measures. *COMAR 10.10.11.22* A trusted partner shall establish a system of technical security measures to protect BAR information integrity, confidentiality, and availability, which include: A. A BAR information security assessment to determine the sensitivity, vulnerabilities, and security of the trusted partner's programs and operations related to the BAR information the trusted partner: (1) Receives; (2) Views; (3) Manipulates; (4) Stores; or (5) Transmits; B. An information system certification based on a technical evaluation as part of and in support of the security process, which establishes the extent to which the trusted partner's computer system used for BAR information meets the security requirements of this chapter; C. Establishing and utilizing procedures and processes to guard against unauthorized access to BAR information by using: (1) Access controls that include: (a) Emergency role-based access of BAR information that documents the instructions for obtaining BAR information during a crisis; (b) User-based access; and (c) The use of encryption and decryption; (2) An alarm that can sense an unauthorized access within the computer system and produce a signaled response such as a: (a) System closure; (b) Time-phased automatic shutdown and restart cycle; or (c) Screen indicating a multiple password failure lockout; (3) Audit controls that record and examine system activity; (4) Audit trails of the use of and access to BAR information collected and used to facilitate a security audit; and (5) Event reporting that shows a screen message indicating an unauthorized request for BAR information access. D. Establishing procedures and processes for computer system authorization control for an individual to obtain access for the use and disclosure of BAR information, which include: (1) Role-based access; (2) User-based access; (3) BAR information authentication that corroborates that BAR information has not been altered or destroyed in an unauthorized manner by using a: (a) Message authentication code; or (b) Digital signature; (4) BAR information custodian authentication that includes: (a) Automatic logoff that causes an electronic session to terminate after a predetermined time of inactivity; and (b) A unique user identifier: (i) Made up of a combination alpha and numeric characters; and (ii) Maintained in security procedures for identifying and tracking individual user identity; and (5) A logon mechanism using a: (a) Password; (b) Personal identification number (PIN); (c) Token; or (d) Any combination of §D(5)(a)—(c) of this regulation; E. A security configuration management plan that includes: (1) A written security plan documenting the rules, procedures, and instructions concerning all components related to BAR information security; (2) Hardware and software installation and maintenance reviews; (3) Security testing to ensure that the selected security features are: (a) Implemented as designed; and (b) Adequate for the operational environment; and (4) Virus checking on a routine and regular basis; F. Security incident procedures that describe how to: (1) Report security incidents and breaches; and (2) Respond to and take action as a result of the receipt of a security incident report; and G. Sanction policies and procedures describing the disciplinary actions and notice of possible civil or criminal penalties an individual may be subject to for misuse or misappropriation of BAR information. #### Regulation .23 Trusted Partner Agreement. *COMAR 10.10.11.23* A. Requirement. The Department may not share BAR information with a person until the person becomes a trusted partner by entering into a trusted partner agreement, using the form developed by the Department. B. The Department shall develop and use a trusted partner form that contains, as applicable, separate clauses that: (1) Establish the length of time that the trusted partner agreement is in effect; (2) Address that confidentiality will survive the termination, expiration, or cancellation of the trusted partner agreement and state that the trusted partner: (a) May not use BAR information in a way that is detrimental to the Department; (b) Shall keep BAR information confidential; (c) Shall limit disclosure of BAR information only: (i) To individuals with a legitimate need in performance of the individuals' duties; and (ii) On a need-to-know basis as prescribed by this chapter; and (d) Shall employ security policies that: (i) Protect the confidentiality of BAR information; and (ii) Prevent improper disclosures or access to BAR information; (3) Require the trusted partner to notify the Department whenever the trusted partner discloses BAR information as allowed by this chapter; (4) Warrant and represent that the trusted partner is in compliance with all applicable State and federal laws and regulations regarding BAR information; (5) Require the trusted partner to execute a trusted partner agreement that upholds the standards and requirements in the trusted partner agreement that the trusted partner has with the Department; (6) Require the trusted partner to notify the Department when there is: (a) An improper or unauthorized: (i) Disclosure of BAR information; or (ii) Access to BAR information; (b) A misuse of BAR information; (c) A computer information system compromise that affects BAR information; or (d) An authorized release of BAR information as set forth in this chapter; (7) Address corrective action by stating: (a) The steps necessary to prevent any further unauthorized disclosure and misuse of BAR information; (b) That the trusted partner shall maintain an incident log of all unauthorized disclosures and misuse of BAR information; and (c) That the trusted partner shall send a copy of incident log entries to the BAR Program; (8) Require the trusted partner to: (a) Return the BAR information that was provided to the trusted partner; and (b) Exercise due diligence to destroy all material based on BAR information in a manner that renders nonidentifiable all documents, memoranda, notes, or other writings created or prepared by or for the trusted partner or BAR information custodian; (9) Require the trusted partner to make available on demand to the Department all policies and procedures relevant to safeguarding BAR information; (10) Address the authority of the individuals signing the trusted partner agreement that state that: (a) The individuals signing the trusted partner agreement have the right and authority to execute the agreement on behalf of their respective entity; and (b) No further approvals are necessary to make the trusted partner agreement binding; (11) State that the trusted partner agreement is the entire agreement between the Department and the trusted partner; (12) State that the trusted partner agreement may not be amended, except as agreed to by the Department in writing; (13) State that no provision or clause in the trusted partner agreement may be waived unless approved in writing by the Department; (14) Identify the individual designated by the trusted partner and authorized by the Department to receive, maintain, and if provided by this chapter, release BAR information; (15) Attest that the BAR information custodian has the trusted partner's agency clearance to receive BAR information; (16) Address a trusted partner's security policy that states the: (a) Value of BAR information; (b) Protection responsibilities; and (c) Organizational commitment for a system to protect the integrity, confidentiality, and availability of BAR information; and (17) State that if a provision, section, subsection, sentence, clause, or phrase of the trusted partner agreement is held invalid, the remaining portions of the trusted partner agreement remain valid. #### Regulation .24 Penalties. *COMAR 10.10.11.24* A. Fine. A person who violates a provision of Health-General Article, Title 17, Subtitle 6, Annotated Code of Maryland, or this chapter is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision. B. Subsequent Offense. Each day a violation is continued after the first conviction is a subsequent offense. ### Chapter 12 — Medical Laboratories — Public Health HIV Testing Programs **Authority:** Health-General Article, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580) **Administrative History:** Regulation .01A, B amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .02B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .03 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .04 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .04D amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .06D, E amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .07B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .09 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .10 amended effective April 1, 2013 (40:6 Md. R. 473) #### Regulation .01 Scope. *COMAR 10.10.12.01* A. This chapter sets the standards and requirements for a person to obtain and maintain a public health testing license to operate a public health testing program to perform rapid HIV antibody testing and rapid hepatitis C virus testing. B. This chapter applies to public health testing programs approved by the Secretary to conduct rapid HIV antibody testing and rapid hepatitis C virus testing. C. This chapter does not apply to any other type of laboratory testing entity such as a: (1) Point-of-care laboratory; (2) Commercial reference laboratory; (3) Hospital; or (4) Physician office laboratory. #### Regulation .02 Definitions. *COMAR 10.10.12.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “CDC” means the federal Centers for Disease Control and Prevention. (2) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988. (3) “Department” means the Maryland Department of Health. (4) “Primary standard” means a general comprehensive standard or set of standards as defined in COMAR 10.10.01.03B. (5) “Public health testing program” means a medical laboratory as defined in COMAR 10.10.01.03B that is affiliated or collaborating with the Department for the purpose of offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing approved by the Secretary. (6) “Public health testing license” means a license as defined in COMAR 10.10.01.03B issued by the Secretary authorizing the director of a public health HIV or hepatitis C (HCV) testing program to offer or perform rapid HIV tests or rapid hepatitis C virus tests. (7) Quality Assessment Plan. (a) “Quality assessment plan” means a planned system of step-by-step activities to ensure that: (i) Testing is being carried out according to the manufacturer's instructions; (ii) Results are accurate and reliable; and (iii) Problems and mistakes are found and corrected to avoid adverse outcomes. (b) “Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed. (8) Quality Control. (a) “Quality control” means the policies and procedures defined in COMAR 10.10.01.03B that monitor and evaluate the analytical or test performance phase of the testing process. (b) “Quality control” includes the operational techniques, tasks, or activities used to find and correct problems that might occur in the test system. (8-1) “Rapid hepatitis C virus test” means a public health hepatitis test that: (a) Uses whole blood as the specimen to detect hepatitis C antibodies; (b) Is waived under the CLIA program; and (c) Provides a test result while the individual being tested is waiting. (9) “Rapid HIV antibody test” means a public health HIV test that: (a) Uses whole blood or oral fluid as the specimen to detect HIV antibodies; (b) Is waived under the CLIA program; and (c) Provides a test result while the individual being tested is waiting. (10) “Secretary” means the Secretary of Health. #### Regulation .03 Incorporation by Reference. *COMAR 10.10.12.03* In this chapter, the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 (2007)” is incorporated by reference. #### Regulation .04 Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing. *COMAR 10.10.12.04* A. A person shall obtain a public health testing license before offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing. B. A person may not: (1) Offer or perform rapid HIV antibody testing or hepatitis C virus testing without obtaining a public health testing license issued under this chapter; or (2) Transfer the public health testing license to another person. C. The Secretary may issue a public health testing license under this chapter if the Secretary determines that the public health testing program meets the requirements of this chapter. D. The Department shall issue a public health testing license that: (1) States that the license is limited to the performance of rapid HIV antibody testing and rapid hepatitis C virus testing; and (2) Lists the: (a) Name of the director; (b) Name of the public health testing program; and (c) Address of the public health testing program. E. To obtain, maintain, or renew a public health testing license, a person shall: (1) Make records and reports available to the Department; (2) Possess a valid CLIA Certificate of Waiver from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; (3) Submit to the Department: (a) When seeking an initial license or license renewal, a quality assessment plan that describes the testing activities; (b) The location of all testing sites; and (c) The name and address of the laboratory that will perform confirmatory tests for the person operating the public health testing program; and (4) Submit amendments or changes to the public health testing program's quality assessment plan to the Department and obtain the Department's approval prior to implementation. F. The Department shall: (1) Review each submitted quality assessment plan to determine compliance with the requirements of this chapter; (2) Conduct on-site surveys of public health testing programs: (a) To investigate a complaint; and (b) Periodically to determine compliance with this chapter; and (3) Approve the plan for implementation by the public health testing program if the plan is in compliance with the requirements of this chapter. G. The Secretary may impose one or more sanctions as provided in COMAR 10.10.08.01—.03 if the Secretary determines that the public health testing program does not meet the standards of this chapter. #### Regulation .05 Quality Assessment Plan and Quality Control Requirements. *COMAR 10.10.12.05* A. Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program. B. Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and activities that occur before, during, and after testing and include the following components: (1) Verifying, before performing a test; that: (a) The testing process works as set forth in the manufacturer's test specifications and instructions; (b) Personnel are trained and competent to perform assigned tasks; (c) Procedures and logistics are in place for: (i) Performing a confirmatory test; (ii) Collecting a specimen for referral to a laboratory to perform a confirmatory test; or (iii) Referring an individual to a health care provider to have a confirmatory test performed; and (d) Biohazardous waste handling procedures are in place; (2) Troubleshooting procedures that: (a) Detect and resolve a problem that occurs during the testing process; (b) Require communication of a problem immediately to the director or appropriate supervisory personnel; (c) State when to discontinue testing; (d) Identify how to take corrective action in response to a problem; and (e) State how to: (i) Document a problem and the actions taken; and (ii) Verify that a corrective action taken has addressed the problem; (3) Procedures and mechanisms to maintain records that document: (a) Personnel training and competency; (b) Specimen referral and transfer; (c) Daily temperatures of the areas that will affect testing results; (d) Quality control test results that include the: (i) Results of the quality control test; (ii) Date and time the control testing was performed; (iii) Lot number and expiration of the test kit; (iv) Lot number and expiration date of the quality controls; and (v) Corrective actions taken if control results are invalid; and (e) Test result records for the individuals who are tested that include the: (i) Test result; (ii) Date and time testing was performed; (iii) Unique laboratory code for the individual being tested; (iv) Test kit lot number and expiration date; (v) Results of internal validity checks; (vi) Action taken if a result is invalid; (vii) Documentation of required confirmatory testing; (viii) Documentation when a specimen is sent for confirmation or the individual is referred for a confirmatory test; (ix) Confirmatory test results, when available; and (x) Identity of the individual who performed the test. #### Regulation .06 Personnel Training and Competency. *COMAR 10.10.12.06* A. Primary Standard. A person seeking or holding a public health testing license shall ensure that the personnel of the public health testing program are trained in how to perform assigned tasks and responsibilities. B. Personnel Training Components. A person seeking or holding a public health testing license shall ensure that personnel training includes the following components: (1) How to perform the test, including procedures performed before, during, and after testing; (2) How the testing is integrated into the overall counseling and testing program; (3) The components of the public health testing program's quality assessment plan; and (4) The use of bloodborne pathogen precautions and biohazard safety. C. Training Method. A person seeking or holding a public health testing license shall ensure that the public health testing program personnel training includes the following activities: (1) Reading the manufacturer's instructions for performing the test; (2) Observing a trained individual performing the test or viewing a video of a trained individual performing the test; (3) Practicing the performance of the test with positive and negative controls; (4) Practicing the specimen collection procedure; and (5) Reviewing the procedures and forms on how to document the testing. D. Personnel Competency. A supervisor or qualified trainer shall assess and document the competency of the public health testing program personnel for each task for which the individual is responsible: (1) Before the individual is permitted to perform testing without assistance for the first time; (2) Annually; and (3) When procedures or test systems are changed. E. A person seeking or holding a public health testing license shall have available and ensure that personnel follow the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988” (2007). #### Regulation .07 Standard Operating Procedures Manual. *COMAR 10.10.12.07* A. Primary Standard. A person seeking or holding a public health testing license shall develop and maintain a standard operating procedures manual (SOPM) that is available to and followed by the public health testing program personnel. B. A person seeking or holding a public health testing license shall ensure that the SOPM includes the step-by-step instructions for the operations, tasks, and techniques occurring before, during, and after testing, including: (1) How to set up the testing site; (2) Use of quality assessment plan components, policies, and procedures; (3) The test manufacturer's product inserts and instructions; (4) Standard precautions for bloodborne pathogens; (5) Use of gloves and other personal protective equipment; (6) Handling and disposal of biohazardous waste; (7) How to provide testing information to an individual before the individual is tested; (8) How to counsel an individual receiving screening test results; and (9) How to refer an individual who has been tested for HIV antibodies or hepatitis C antibodies, or both, for services as prescribed in COMAR 10.18.08.10C. #### Regulation .08 Public Health Testing Program Director. *COMAR 10.10.12.08* A. Primary Standard. A person seeking or holding a public health testing license shall employ or otherwise engage the services of a director to oversee and manage the public health testing program. B. The director of a public health testing program shall oversee the planning, organization, direction, operation, and review of the program's operations, including: (1) Recruiting competent personnel; (2) Providing and documenting initial training and continuing education of program personnel; (3) Communicating and consulting with program personnel on a regular basis; (4) Conducting and documenting periodic on-site visits at the testing sites; (5) Maintaining the quality assessment plan; and (6) Ensuring that the program, testing site, and personnel meet applicable federal requirements and all standards and requirements set forth in this chapter. #### Regulation .09 Manufacturer's Requirements. *COMAR 10.10.12.09* A. Primary Standard. In addition to meeting the quality assessment plan requirements set forth in Regulation .05 of this chapter, a person seeking or holding a public health testing license shall ensure that public health testing program personnel meet the requirements and follow the manufacturer's test specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used. B. A person seeking or holding a public health testing license shall ensure that public health testing program personnel pay attention to the precautions and warnings set forth in the manufacturer's testing specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used for: (1) Product usage; (2) Test system and kit controls; and (3) The step-by-step instructions for performing the rapid HIV antibody test or rapid hepatitis C virus test. #### Regulation .10 Confirmatory Test. *COMAR 10.10.12.10* When an individual has a positive test result with the rapid HIV antibody test or rapid hepatitis C virus test, a person seeking or holding a public health testing license to offer or perform testing shall: A. Offer to perform a confirmatory test; B. Collect a specimen to refer to a laboratory to perform a confirmatory test; or C. Refer that individual to a health care provider to have a confirmatory test performed. ### Chapter 13 — Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants **Authority:** Health-General Article, §§13-101—13-103, 13-108—13-112, 13-601—13-605, 17-201—17-206, 17-210, 17-211, 17-215, and 17-216, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01— .27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490) **Administrative History:** Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .06B amended as an emergency provision effective July 1, 2012 (39:15 Md. R. 962); amended permanently effective August 20, 2012 (39:16 Md. R. 1080) **Administrative History:** Regulation .06B amended effective April 27, 2015 (42:8 Md. R. 608); April 14, 2025 (52:7 Md. R. 321) **Administrative History:** Regulation .12 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .12C amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454) **Administrative History:** Regulation .13 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .14 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .15 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .16 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .18B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .20A, C amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .21 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .23 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .24A, D amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .25 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .26A amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .27C amended effective April 24, 2017 (44:8 Md. R. 404) #### Regulation .01 Purpose. *COMAR 10.10.13.01* A. This chapter, together with COMAR 10.52.12, establishes a coordinated Statewide system for the screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development. B. This chapter also protects the public health by ensuring that accurate and reliable newborn screening and diagnostic test results are provided to a newborn infant's health care providers by requiring a medical laboratory performing screening tests, diagnostic tests, or both, on newborn infants for hereditary disorders, congenital disorders, or both, to: (1) Operate under reliable procedures and test methods; (2) Employ qualified personnel; (3) Establish and maintain reliable quality control and quality assurance programs; and (4) Interact effectively with components of the Department's coordinated Statewide Newborn Screening Program to identify newborn infants who may be at risk for a hereditary or congenital disorder. #### Regulation .02 Scope. *COMAR 10.10.13.02* This chapter: A. Identifies standards and requirements for a medical laboratory performing screening tests, diagnostic tests, or both, for hereditary and congenital disorders on blood-spot specimens from newborn infants; and B. Addresses the following newborn screening and diagnostic tests: (1) Screening tests, which are: (a) First-tier tests; and (b) Supplemental tests; and (2) Diagnostic tests, which are: (a) Second-tier tests; and (b) Supplemental tests. #### Regulation .03 Definitions. *COMAR 10.10.13.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Abnormal test result” means a first-tier, supplemental, or second-tier test result that: (a) Falls outside the normal range for the analyte measured; and (b) Triggers a request for additional testing or is diagnostic for a disorder. (2) Allele. (a) “Allele” means any one of a series of two or more different forms of a gene or DNA sequence that can exist at a single locus on a chromosome. (b) “Allele” includes the gene or DNA sequence for hemoglobin traits and disease states, such as hemoglobin S (HbS) for sickle cell disease. (3) “Analyte” means the substance or chemical constituent in blood being measured in a screening test used to detect the disorders listed in Regulation .12C of this chapter. (4) Birthing Facility. (a) “Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants. (b) “Birthing facility” includes a: (i) Birthing service that is licensed or accredited as a unit of a hospital; and (ii) Freestanding birthing center as defined in COMAR 10.05.02.01B. (5) Blood-Spot Specimen. (a) “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests. (b) “Blood-spot specimen” includes: (i) The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth; (ii) The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and (iii) A blood-spot specimen collected subsequent to a blood-spot specimen specified in §B(5)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.52.12. (6) “Borderline result” means a screening test result that is at or near the established cut-off level for a particular analyte. (7) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988. (8) Congenital Disorder. (a) “Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth. (b) “Congenital disorder” does not include a condition that results from: (i) An intrauterine infection; or (ii) A birth injury. (9) “Council” means the State Advisory Council on Hereditary and Congenital Disorders. (10) “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested. (11) “Cut-off level” means a pre-determined, measurable value established for an analyte detected by a screening test, where that value is used to determine when a newborn infant's test result is normal, borderline, or abnormal. (12) “Department” means the Maryland Department of Health. (13) “Diagnostic test” means a test that is used to establish or confirm the presence of a: (a) Specific disease; or (b) Hereditary or congenital disorder. (14) “First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth. (15) “First–tier test” means a blood test performed on a newborn infant’s blood-spot specimen that: (a) Indicates the probable presence or absence of a hereditary or congenital disorder; or (b) Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder. (16) “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in COMAR 10.52.12.12. (17) Hereditary Disorder. (a) “Hereditary disorder” means a disorder that: (i) Is transmissible through the genetic material deoxyribonucleic acid (DNA); or (ii) Arises through the improper processing of information in the genetic material. (b) “Hereditary disorder” includes: (i) Hemoglobin disorders; (ii) Metabolic disorders; and (iii) Endocrine disorders. (18) “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility. (19) “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(18) of this regulation. (20) “Metabolic Disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by: (a) Direct analysis of the enzyme, hormone, or protein; or (b) Testing for a substance whose metabolism is altered as a result of the defect. (21) “Newborn” or “newborn infant” means an infant: (a) Born in Maryland; (b) Born on federal property within Maryland; (c) Born outside of Maryland to parents whose residence is in Maryland; (d) From whom a blood-spot specimen was collected and submitted to the Department’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth; (e) Who has a screening test requested by the Follow-Up Unit: (i) For first-tier screening follow-up; (ii) For confirmation of a previous screening test result; or (iii) To assist with a newborn infant's diagnosis, therapy, or follow-up care; or (f) Who is in Maryland. (22) Newborn Screening or Screening. (a) “Newborn screening” or “screening” means one or more first-tier tests. (b) “Newborn screening” or “screening” includes: (i) First-tier testing on a first, second, or subsequent blood-spot specimen; and (ii) Supplemental first-tier testing. (23) Newborn Screening Program. (a) “Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that: (i) Newborn infants are given the opportunity to be tested; (ii) At risk newborn infants who are tested are identified and located; (iii) Newborn infants are given access to necessary follow-up testing; (iv) Diagnostic tests are available and the diagnosis is made or ruled out; and (v) Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment. (b) “Newborn Screening Program” includes: (i) The Department's public health laboratory as the sole screening laboratory; (ii) Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a Departmental mutual aid agreement; (iii) Supplemental and second-tier testing performed by a state public health laboratory or by a permitted commercial or research laboratory; (iv) The Follow-Up Unit; and (v) The State Advisory Council on Hereditary and Congenital Disorders. (24) “Normal limit” means a measurable, numerical value or range that is considered not to indicate or establish the presence of a hereditary or congenital disorder. (25) “Permittee” means a person issued a permit by the Secretary to operate a medical laboratory as defined in COMAR 10.10.01.03B. (26) “Public health laboratory” means: (a) The Department's public health laboratory; and (b) Another state's public health laboratory or a commercial laboratory permitted in Maryland that is approved under a Departmental emergency mutual aid agreement to perform newborn screening tests on Maryland newborns. (27) Quality Assessment Plan. (a) “Quality assessment plan” means a planned system of step-by-step activities to ensure that: (i) Testing is carried out according to the manufacturer's instructions; (ii) Testing results are accurate and reliable; (iii) Testing problems and errors are found and corrected to avoid adverse health outcomes for newborn infants; and (iv) Testing results are reported and communicated in a timely manner as required by this chapter. (b) “Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed. (28) “Quality control” has the meaning stated in COMAR 10.10.06.03B. (29) Screening Test. (a) “Screening test” means a first-tier test used to detect a hereditary or congenital disorder listed in Regulation .12 of this chapter. (b) “Screening test” includes a test performed on a: (i) First screening blood-spot specimen; (ii) Second screening blood-spot specimen; or (iii) Subsequent screening blood-spot specimen. (c) “Screening test” does not include a: (i) Diagnostic test; or (ii) Second-tier test. (30) “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal. (31) Second-Tier Test. (a) “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result. (b) “Second-tier test” includes a test that: (i) Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder; (ii) Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or (iii) Is diagnostic because it confirms the presence of a hereditary or congenital disorder. (32) “Secretary” means the Secretary of Health or the Secretary's designee. (33) “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is: (a) Used to detect a hereditary or congenital disorder not specified in Regulation .12C of this chapter; or (b) Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.52.12. (34) “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in Regulation .21B and C of this chapter. #### Regulation .04 Permit. *COMAR 10.10.13.04* A. Eligibility. (1) Except as set forth in a Departmental mutual aid agreement, the Department's public health laboratory is the sole laboratory that may hold a State permit to perform and that may perform a first-tier newborn screening test on a newborn infant. (2) A medical laboratory other than the State's public health laboratory may obtain a permit to perform: (a) A supplemental test; (b) A second-tier test; or (c) Supplemental and second-tier tests. B. Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall: (1) Obtain and maintain a valid: (a) Permit issued by the Secretary to operate a medical laboratory; and (b) CLIA Certificate from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; and (2) Meet applicable standards and requirements for: (a) A medical laboratory, as set forth in COMAR 10.10.01—.08; and (b) Testing for hereditary or congenital disorders in a newborn infant as set forth in this chapter. #### Regulation .05 Inspection Requirements. *COMAR 10.10.13.05* A. Inspection Authority. The Department may conduct on-site inspections of a permittee or applicant for a permit to perform supplemental or second-tier tests to screen for or diagnose congenital and hereditary disorders in newborn infants. B. Inspection Types. The Department may conduct the following types of inspections to assess compliance with the requirements of this subtitle and COMAR 10.52.12: (1) An initial inspection before issuing a permit; (2) A routine inspection during the permit period; and (3) An inspection subsequent to a complaint. #### Regulation .06 Fees. *COMAR 10.10.13.06* A. Permit Fees. A permittee or applicant for a permit that is not exempt under COMAR 10.10.04.01C, or that is not another state's public health laboratory approved to provide newborn screening tests under a Departmental mutual aid agreement, shall pay to the Department the applicable fees as required by COMAR 10.10.04 and this regulation. B. Screening and Follow-up Fee Requirement. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay a fee of $163.74 per newborn infant to the Department. C. Screening and Follow-Up Fee Payment. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay to the Department the total fees owed: (1) On a quarterly basis; and (2) Within 30 days of receiving an invoice from the Department. #### Regulation .07 Director Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.07* A. Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director. B. Director Qualifications. The director shall: (1) Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04; and (2) Possess a current license as a laboratory director issued by the state in which the laboratory is located if: (a) The laboratory is not located in Maryland; and (b) Licensing is required by the state in which the laboratory is located. C. Director Responsibilities. The director is responsible for: (1) The overall operation and administration of the laboratory, including the employment of a sufficient number of competent personnel; (2) Ensuring that each first-tier, supplemental, or second-tier test conducted is performed accurately and reliably in all aspects of the testing process, including the preanalytic, analytic, and post-analytic phases of the total testing process; and (3) Ensuring compliance with: (a) This chapter; (b) The applicable parts of COMAR 10.10.01— 10.10.08; and (c) COMAR 10.52.12. #### Regulation .08 Technical Supervisor Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.08* A. Technical Supervisor Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a technical supervisor. B. Director as Technical Supervisor. The director may function as the technical supervisor if the director meets the technical supervisor qualifications specified in this regulation. C. Technical Supervisor Qualifications. The technical supervisor shall meet the qualifications for a technical supervisor set forth at COMAR 10.10.07.05A(1) and B(7). D. Technical Supervisor Responsibilities. A technical supervisor shall be: (1) Responsible for the: (a) Technical and scientific methods used in the laboratory; and (b) Oversight of the laboratory; (2) Available to the laboratory personnel on an as-needed basis to provide supervision as specified in this chapter; and (3) Accessible to the laboratory to provide on-site, telephonic, or electronic consultation to laboratory personnel and clients. #### Regulation .09 Clinical Consultant Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.09* A. Clinical Consultant Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a clinical consultant. B. Director as Clinical Consultant. The director may function as the clinical consultant if the director meets the qualifications set forth under §C of this regulation. C. Clinical Consultant Qualifications. The clinical consultant shall be: (1) A doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy; and (2) Board certified by the American Board of Medical Genetics as a: (a) Clinical geneticist; (b) Medical geneticist; or (c) Biochemical geneticist. D. Clinical Consultant Responsibilities. A clinical consultant shall provide clinical consultation related to: (1) Inquiries concerning specific newborn screening tests; (2) Interpretation of specific test results; (3) Possible diagnostic or supplemental testing; and (4) Assistance in ensuring that appropriate tests are ordered to meet clinical expectations. #### Regulation .10 General Supervisor Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.10* A. General Supervisor Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a general supervisor. B. General Supervisor Qualifications. The general supervisor shall: (1) Meet the qualifications for a general supervisor set forth at COMAR 10.10.07.06B(1); and (2) Have at least 6 months experience supervising the operation of applicable test systems, including: (a) Tandem mass spectrophotometry (MS/MS); (b) Time-resolved immunofluorometry; (c) Enzyme-linked immunosorbent assay (ELISA) systems; and (d) Isoelectric focusing and high-performance liquid chromatography. C. General Supervisor Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463, including: (1) Supervising the: (a) Day-to-day operation of the laboratory; and (b) Personnel performing tests and reporting test results; and (2) Being accessible to testing personnel at all times testing is performed to provide on-site, telephonic, or electronic consultation and resolve technical problems in accordance with policies and procedures established and approved by the director and technical supervisor. #### Regulation .11 Testing Personnel Requirement and Qualifications. *COMAR 10.10.13.11* A. Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ sufficient laboratory testing personnel to perform testing in accordance with the requirements of this chapter. B. Qualifications. Testing personnel shall meet the qualifications set forth at COMAR 10.10.07.07. #### Regulation .12 First-Tier, Supplemental, and Second-Tier Tests. *COMAR 10.10.13.12* A. First-Tier Tests; Requirement. The Department’s public health laboratory shall perform first-tier tests on all screening blood-spot specimens collected from a newborn infant. B. First-Tier Tests; Testing Limitations. (1) Only the Department's public health laboratory may screen for the disorders listed in §C of this regulation. (2) A permittee may perform a supplemental or a second-tier test only when the test is requested by an individual authorized to request a medical laboratory test as provided in COMAR 10.10.06.02. C. First-Tier Tests. The Department’s public health laboratory shall perform a first-tier test on a newborn infant to screen for the following hereditary and congenital disorders, which are approved for screening by the Council and the Secretary: (1) Biotinidase deficiency; (2) Congenital adrenal hyperplasia (CAH); (3) Hypothyroidism; (4) Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT); (5) Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE); (6) Galactokinase Galactosemia, galactokinase deficiency (GALK1); (7) Sickle cell disease; (8) Sickle cell disease: S beta-thalessemia; (9) Sickle C disease: SC disease; (10) Other hemoglobin variants; (11) Phenylketonuria (PKU); (12) Hyperphenylalaninemia (Hyper-PHE); (13) Biopterin cofactor biosynthesis defects (BIOPT-BS); (14) Biopterin cofactor regeneration defects (BIOPT-REG); (15) Tyrosinemia, type I; (16) Tyrosinemia, type II; (17) Tyrosinemia, type III; (18) Homocystinuria; (19) Hypermethioninemia; (20) Branched chain ketoaciduria (BCK), also called maple syrup urine disease (MSUD); (21) Citrullinemia, type I; (22) Citrullinemia, type II; (23) Arginosuccinic aciduria; (24) Argininemia; (25) Methylmalonic acidemia, mutase deficiency (MMA); (26) Methylmalonic acidemia, adenosylcobalamin synthesis defects A and B (Cbl A, B); (27) Methylmalonic acidemia, adenosylcobalamin synthesis defects C and D (Cbl C, D); (28) Propionic acidemia (PA); (29) Isovaleric acidemia (IVA); (30) Glutaric aciduria type I (GA I); (31) 3-Hydroxy-3-methylglutaryl-CoA (HMG) lysase deficiency; (32) Isobutryl-CoA dehydrogenase (IBCD) deficiency; (33) 2-Methylbutyryl-CoA dehydrogenase deficiency (2MBG); (34) 3-Methlycrotonyl-CoA carboxylase deficiency (3MCC); (35) 3-Methlyglutaconyl-CoA hydratase deficiency (3MGA); (36) 2-Methyl-3-hydroxybutyrl-CoA dehydrogenase deficiency (2M3HBA); (37) Mitochondrial acetoacetyl-CoA thiolase (3-ketothiolase) deficiency (BKT); (38) Multiple carboxylase deficiency (MCD); (39) Malonic acidemia (MAL); (40) Medium chain acyl-CoA dehydrogenase deficiency (MCAD); (41) Medium chain ketoacyl-CoA thiolase deficiency (MCKAT); (42) Short chain acyl-CoA dehydrogenase deficiency (SCAD); (43) Short chain 3-hydroxy acyl Co-A dehydrogenase deficiency (SCHAD); (44) Very long chain acyl-CoA dehydrogenase deficiency (VLCAD); (45) 3-hydroxy long chain acyl-CoA dehydrogenase deficiency (LCHAD); (46) Multiple acyl-CoA dehydrogenase (MAD) or glutaric acidemia type II deficiency (GA II); (47) Carnitine/acylcarnitine translocase deficiency (translocase deficiency); (48) Carnitine palmitoyl transferase type I deficiency (CPT I); (49) Carnitine palmitoyl transferase type II deficiency (CPT II); (50) Carnitine uptake disorder; (51) Trifunctional protein deficiency (TFP); (52) 2,4-dienoyl-CoA reductase deficiency (DE RED); (53) Cystic fibrosis; (54) Severe combined immunodeficiency (SCID); (55) Pompe disease; (56) Fabry disease; (57) Spinal muscular atrophy (SMA); (58) Mucopolysaccharidosis type I (MPS I); (59) Mucopolysaccharidosis type II (MPS II); (60) X-linked Adrenoleukodystrophy (X-ALD); (61) Guanidinoacetate Methyltransferase Deficiency (GAMT); and (62) Infantile Krabbe Disease. D. Approved Methods: (1) A permittee shall use: (a) A colorimetric method for testing for a biotinidase deficiency, which is the disorder listed at §C(1) of this regulation; (b) A fluorometric method when testing for galactosemia, which is the disorder listed at §C(4)—(6) of this regulation; (c) A fluorescent-linked immunoassay method when testing for the hereditary or congenital disorders listed in §C(2) and (3) of this regulation; (d) Isoelectric focusing followed by high-performance liquid chromatography when testing for sickle cell disease, which is the disorder listed at §C(7)—(10) of this regulation; (e) Tandem mass-spectrometry when testing for the metabolic disorders listed in §C(11)—(52) of this regulation; (f) IRT/IRT (immunoreactive trypsinogen/immuno-reactive trypsinogen) when testing for cystic fibrosis, which is the disorder listed in §C(53) of this regulation; and (g) Real time polymerase chain reaction method when testing for severe combined immunodeficiency, which is listed in §C(54) of this regulation. (2) A permittee shall have 60 days from the amendment's effective date to comply with any amendment made by the Secretary to §D of this regulation. #### Regulation .13 Screening Test Blood-Spot Specimens — Collection and Test Requisition. *COMAR 10.10.13.13* A. Blood-Spot Specimen Collection. (1) A person shall collect a newborn infant’s blood-spot specimen for testing under this chapter by using only the special blood-spot specimen collection test requisition card provided by the Department. (2) The Department shall provide the special blood-spot specimen collection test requisition card to the: (a) Individual in charge of a birthing facility or the individual’s designated representative; or (b) Home birth attendant. (3) The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall collect a blood-spot specimen consisting of heel-stick whole blood obtained: (a) When a newborn infant is 24 to 48 hours old; (b) On a blood-spot specimen collection test requisition card provided by the Department; and (c) As set forth in Regulation .14 of this chapter. B. Blood-Spot Specimen Collection Test Requisition Card Information. An individual shall record the following information as specified on the Department-supplied blood-spot specimen collection test requisition card: (1) Newborn infant information, including: (a) Name; (b) Date of birth; (c) Time of birth; (d) Current weight; (e) Gender; (f) Race; (g) Gestational age; (h) Birthing facility identification, including the: (i) Facility name; (ii) Facility street address, city, state, and zip code; and (iii) Newborn infant's medical record or chart number; (i) Date and time of first feeding; (j) Type of feeding, such as: (i) Breast; (ii) Lactose-containing formula; or (iii) Formula containing no lactose; (k) Transfusion history, including transfusion date and time; (l) General health status of the newborn infant; and (m) The total protein and calorie intake for any newborn infant in a neonatal intensive care setting; (2) Blood-spot specimen information, including: (a) Date of collection; (b) Time of collection; and (c) Initials or other identifier of the individual who collected the blood-spot specimen; (3) Mother or guardian information, including: (a) Name; (b) Street address, city, state, and zip code; and (c) Telephone number where the mother or guardian may be reached; (4) Information on the pediatrician or attending physician who will be following the newborn infant, including the physician's: (a) Name; (b) Street address, city, state, and zip code; and (c) Telephone number; and (5) Other information that can affect the test results or the interpretation of the test results when applicable, such as that antibiotics were administered to the: (a) Mother; or (b) Newborn infant. #### Regulation .14 Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements. *COMAR 10.10.13.14* A. Standard Operating Procedure. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to: (1) Ensure and maintain blood-spot specimen integrity, quality, and acceptability; (2) Ensure proper: (a) Site preparation and cleaning; (b) Performance of the heel stick puncture; and (c) Application of whole blood to the collection test requisition card; (3) Identify precautions against: (a) Milking or squeezing the blood-spot specimen collection site; (b) Layering successive drops of blood on the same circle on the blood-spot specimen collection test requisition card; (c) Filling the circles on both sides of the filter paper; (d) Touching or smearing a blood-spot specimen before it is fully air-dried; (e) Scratching or abrading the blood-spot specimen; (f) Not allowing a blood-spot specimen to dry thoroughly before sending the blood-spot specimen collection test requisition card to a laboratory; and (g) Damaging, stretching, or wrinkling the filter paper before, during or after blood-spot specimen collection; (4) Recognize unsatisfactory blood-spot specimens; and (5) Handle and temporarily store a blood-spot specimen collection test requisition card, including the procedures and techniques for: (a) Drying blood-spot specimens; (b) Stacking of blood-spot specimen collection test requisition cards; and (c) Temporarily storing blood-spot specimen collection test requisition cards. B. Submission and Delivery Requirements. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall transport and deliver to the Department’s public health laboratory a newborn infant blood-spot specimen collection test requisition card using: (1) An employee or private courier; (2) A commercial carrier providing: (a) Overnight express delivery; or (b) Priority delivery; (3) A county or State operated courier system, where that service is available; or (4) A combination of §B(1)—(3) of this regulation. #### Regulation .15 Test Blood-Spot Specimens — Use, Research, Storage, and Retention. *COMAR 10.10.13.15* A. Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter. B. Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the: (1) Research is approved in writing by the Department's: (a) Newborn Screening Program; and (b) Institutional Review Board; and (2) Researcher acknowledges in writing that the researcher will return all untested blood-spot specimens to the Department’s public health laboratory within 6 months of completing the approved research. C. Storage. A permittee or researcher shall store a newborn infant blood-spot specimen in a sealed, moisture-proof container at between 2ºC and 6ºC. D. Retention. (1) A permittee shall: (a) Retain a newborn infant’s gel, produced when testing for hemoglobin disorders, for at least 90 days after testing is complete; and (b) Return to the State’s public health laboratory all untested blood-spot specimens received from the Department’s public health laboratory for supplemental or diagnostic testing within 90 days after testing is completed by the permittee. (2) The Department’s public health laboratory shall retain and maintain for 25 years a newborn infant’s blood-spot specimen after the blood-spot specimen is received for screening, supplemental testing, or diagnostic testing. #### Regulation .16 Test Records — Retention. *COMAR 10.10.13.16* The Department’s public health laboratory shall retain and maintain electronically or as a hard copy for 25 years the: A. Top copy of the requisition portion of the blood-spot specimen collection test requisition card; B. All test results and reports; C. Electronic data bases; and D. Supporting documents that show how a reported test result was obtained and verified, including but not limited to: (1) Quality control records; (2) Instrument maintenance and repair records; (3) Test reagent records; and (4) Instrument and test system data. #### Regulation .17 Testing — First-Tier. *COMAR 10.10.13.17* A. The Department’s public health laboratory shall test, using first-tier tests, appropriately timed and collected blood-spot specimen of a newborn infant’s blood for the disorders listed in Regulation .12C of this chapter. B. Full-Term Healthy Newborn Infants. (1) If a newborn infant is born at term and is healthy, the Department’s public health laboratory shall conduct a: (a) First screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the full-term healthy newborn infant is between 24 and 48 hours old; and (b) Second screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 10 and 14 days old. (2) If the first blood-spot specimen is collected when a full term healthy newborn infant is younger than 24 hours old, the Department’s public health laboratory shall conduct a: (a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the newborn infant is between 24 hours and 7 days old; and (b) Third screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 1 and 4 weeks old. C. Premature or Ill Newborn Infant. (1) If a newborn infant who is born prematurely or expected to be ill for more than 14 days was younger than 24 hours old when the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct a: (a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter when the newborn infant is between 24 hours and 3 days old; and (b) Third screening using first-tier tests when the newborn infant is between 7 days and 14 days old to screen for: (i) Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter; (ii) Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; (iii) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and (iv) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter. (2) If a newborn infant who is born prematurely or expected to be ill for more than 14 days was 24 hours old or older at the time the newborn infant’s blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall perform a second screening to screen for: (a) Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter; (b) Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; (c) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and (d) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter. (3) If a newborn infant was transfused before the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct, in addition to any other screenings specified in §B(1) and (2) of this regulation, a fourth screening using first-tier tests on a blood-spot specimen collected 4 months after a newborn infant’s last transfusion to screen for: (a) Hemoglobin as specified in Regulation .12C(7)—(10) of this chapter; (b) Biotinidase as specified in Regulation .12C(1) of this chapter; and (c) Galactose-1-P-uridyl-1-transferase as specified in Regulation .12C(3) of this chapter. #### Regulation .18 Testing — Second-Tier and Supplemental. *COMAR 10.10.13.18* A. When a test request is made by an individual authorized to request a laboratory test, as set out in COMAR 10.10.06.02: (1) A permittee other than the Department's public health laboratory may perform a second-tier or supplemental test; and (2) The Department's public health laboratory may perform a second-tier test. B. A permittee: (1) May not contract out, subcontract, or otherwise transfer supplemental or second-tier testing to another laboratory that does not hold a Maryland permit in the discipline of diagnostic and supplemental testing for hereditary and congenital disorders in newborns; (2) Shall complete a second-tier or supplemental test on a blood-spot specimen within 3 working days after the blood-spot specimen arrives at the laboratory; and (3) Shall report the results of a second-tier or supplemental screening test as required in Regulations .23 and .24 of this chapter. #### Regulation .19 Proficiency and Competency Testing for Newborn Screening Tests. *COMAR 10.10.13.19* A permittee shall: A. Meet all requirements set forth in COMAR 10.10.05; B. Successfully participate in one or more approved proficiency testing programs that cover all first-tier, second-tier, and supplementary tests offered or performed; C. Evaluate and document performance, semiannually during the first year of testing and annually thereafter, of all individuals responsible for testing; and D. In addition to the proficiency testing requirement in §A of this regulation, participate in the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program. #### Regulation .20 Quality Control. *COMAR 10.10.13.20* A. Quality Control Program. (1) A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports. (2) A permittee's quality control program shall: (a) Cover all tests, methods, and procedures performed by the laboratory; and (b) Meet the standards and requirements set forth in this chapter and COMAR 10.10.06. (3) A permittee's quality control procedures and practices shall include, but are not limited to, the use of: (a) Analyses of reference materials to ensure the reproducibility and accuracy of test results; (b) Systems to ensure proper functioning of instruments, equipment, reagents, and performance of laboratory personnel; (c) Valid reagents, equipment, calibration, and systematic procedural checks; (d) A system that ensures timely and pertinent error detection and correction for the review and reporting of test results; and (e) Quality control materials from the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program. B. Adequacy of Methods and Equipment. To ensure the adequacy of test methods, test systems, and equipment, a permittee shall: (1) Employ methods, test systems, and equipment that provide accurate and reliable test results and reports; (2) Have sufficient and suitable equipment and instruments to perform the type and volume of tests offered and performed by the laboratory; (3) Perform tests in a manner that provides accurate and reliable test results; (4) Monitor test methods, instruments, and testing systems, where applicable, for the following performance characteristics: (a) Method, instrument, and test system detection limits and cutoff levels; (b) Precision; (c) Accuracy; (d) Specificity; (e) Sensitivity; (f) Interferences; and (g) Other related test variables that affect test results; and (5) Have adequate quality control systems and procedures in place to: (a) Obtain and verify a statistically valid number of counts or measurement levels to give accurate and reliable test results for an analytical instrument, each day an instrument is used for testing; and (b) Report results: (i) As set forth in COMAR 10.10.06.04; (ii) As set forth in 42 CFR §493.1291; and (iii) Within the time frames required by this chapter. C. Supplies, Reagents, and Materials. (1) A permittee shall ensure that supplies, reagents, and other materials used in the collected, handling, testing, and storing of newborn blood-spot specimens are stored, labeled, checked for proper reactivity, and used according to the provisions of this chapter. (2) A permittee shall: (a) Label laboratory supplies and materials used in the testing process, including reagents, solutions, controls, and calibrators to indicate the: (i) Identity of reagents, solutions, controls, and calibrators; (ii) Strength or concentration; (iii) Storage requirements; (iv) Preparation and expiration date; (v) Identity of the preparer; and (vi) Other pertinent information that affects test performance; (b) Store laboratory materials in the manner recommended by the manufacturer; (c) Test representative samples of each lot of materials used for or in the process of testing blood-spot specimens on a regularly scheduled basis to determine that each lot of test material is capable of performing as required; and (d) Use supplies, reagents, kits, test systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer. (3) A permittee may not use supplies, reagents, kits, test systems, or other materials in the testing process that have: (a) Exceeded the materials' established expiration dates; (b) Substandard reactivity; or (c) Deteriorated. #### Regulation .21 Quality Assessment and Quality Assurance. *COMAR 10.10.13.21* A. A permittee shall: (1) Establish and follow a written quality assessment plan that covers all phases of the testing process; (2) Meet the applicable quality assurance requirements of COMAR 10.10.06; and (3) Have an accessioning mechanism or system that: (a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and (b) Identifies a specific analyte that requires retesting when a newborn infant's prior screening test results for that analyte are abnormal or border-line abnormal. B. A permittee may not test a blood-spot specimen exhibiting: (1) Blood that did not saturate the filter paper; (2) A circle containing no blood; (3) A blood clot or tissue on the surface of the blood; (4) A circle over-saturated with blood showing dark areas in the circle or at the perimeter; (5) Blood that appears layered or clotted; or (6) Serum rings or blood that appears diluted, discolored, or contaminated. C. A permittee may not test a blood-spot specimen: (1) Collected more than 10 days before the screening test is to be started; (2) That is unaccompanied by information necessary for the testing to be meaningful, including the: (a) Age of the newborn infant; (b) Identification of the newborn infant; (c) Date and time of blood-spot specimen collection; (d) Date and time of birth; (e) Newborn infant's weight; and (f) Date and time of a newborn infant's first feeding; (3) If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or (4) If the newborn infant was younger than 24 hours old or the newborn's age was unknown at the time of collection and the requested screening test is for: (a) Congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter; or (b) Thyroxine or thyroid stimulating hormone as specified in Regulation .12C(4) of this chapter. D. Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail: (1) That the blood-spot specimen cannot be tested; and (2) To submit another blood-spot specimen as soon as possible. E. If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall: (1) Give prompt notice of the erroneous or questionable patient test result to the: (a) Person who requested that the test be performed; (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; and (c) Follow-Up Unit; (2) Provide corrected reports to the persons notified in §E of this regulation; (3) Maintain duplicates of both the original report and the corrected report; (4) Conduct a quality assessment of all phases of the testing process to determine the cause of the erroneous or questionable test result; (5) Take the necessary remedial or corrective action to prevent recurrence of the problem; and (6) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including: (a) Notifying a parent or guardian of the newborn infant of the erroneous or questionable result; (b) Retesting the same blood-spot specimen; (c) Testing a new blood-spot specimen; and (d) Retesting the same blood-spot specimen and testing a new blood-spot specimen. #### Regulation .22 Quality Assurance — Continuity of Operations and Disaster Recovery Plan. *COMAR 10.10.13.22* A permittee shall develop, implement, and maintain written continuity of operations and disaster recovery plans that ensure the continuous performance of essential functions and operations: A. During an emergency; or B. When the laboratory temporarily can no longer meet the requirements and standards set forth in this chapter. #### Regulation .23 Reporting Test Results. *COMAR 10.10.13.23* A. All Test Results. For a newborn infant, a permittee shall: (1) Report all first-tier, supplemental, and second-tier results to: (a) The person who requested the test; and (b) An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including: (i) A physician specialist; and (ii) Personnel in the Follow-Up Unit; (2) Report to the persons listed in §A(1) of this regulation within 3 working days after the laboratory obtains the blood-spot specimen, all test results that are within normal limits; (3) Report to a person requesting a second or subsequent screening the test results from the newborn infant's prior screening if not previously reported to the person; (4) Include with each report the following information: (a) Date the blood-spot specimen was received in the laboratory; (b) Date of the report; and (c) Cut-off level for each reported analyte; and (5) Report all abnormal test results to the Follow-Up Unit on the same day that a test result is obtained and reviewed. B. Specific Test results. A permittee may not report a test result as being within normal limits for: (1) Amino acid levels for disorders specified in Regulation .12C(11)—(24) of this chapter and for a total galactose level for galactosemia as specified in Regulation .12C(3) of this chapter if: (a) A newborn infant was not on milk or formula feeding at least 24 hours before the blood-spot specimen was collected; or (b) The time of milk or formula feeding is unknown; or (2) 17-hydroxy progesterone results for congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter and thyroxine and thyroid stimulating hormone for hypothyroidism as specified in Regulation .12C(4) of this chapter if the blood-spot specimen was collected when the newborn infant was: (a) Younger than 24 hours old; or (b) Of unknown age. #### Regulation .24 Reporting Abnormal Test Results to the Follow-Up Unit. *COMAR 10.10.13.24* A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by: (1) Telephoning and personally speaking to an individual in the Follow-Up Unit; (2) Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and (3) Following up a telephonic report within 24 hours with a report by facsimile or electronic mail to the Follow-Up Unit. B. Verification Requirement. A permittee shall contact the Follow-Up Unit by telephone at least once every 6 months to ensure that the permittee is able to meet the requirements in §A of this regulation. C. Reporting Requirements; General. A permittee shall provide with each abnormal result, where applicable, the: (1) Identity or name of each analyte measured; (2) Measured numerical concentration or range of: (a) Each analyte measured; and (b) All related analytes measured; (3) Value of any relevant ratios used to determine abnormality; (4) Postnatal age of the newborn infant; (5) Appropriate gestational age/birth weight control range; (6) Cut-off level for the analyte of a hereditary or congenital disorder; and (7) Measure of the degree of abnormality of the test result. D. Reporting Requirements; Sickle Cell Disease Hemoglobin. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)—(10) of this chapter for sickle cell disease in terminology that includes: (1) The alleles present in decreasing quantitative order; and (2) Specifying trait states and possible disease states for at least the following alleles: (a) Hemoglobin C; (b) Hemoglobin D; (c) Hemoglobin E; (d) Hemoglobin G; (e) Hemoglobin O; and (f) Hemoglobin S. #### Regulation .25 Reporting System and Communication Software. *COMAR 10.10.13.25* A permittee shall: A. Have available and use a reliable and accurate electronic information system that is capable of collecting, compiling, transferring, and communicating all normal and abnormal test results to the Follow-Up Unit; and B. Provide the Follow-Up Unit, where applicable, with: (1) The necessary information system and electronic communications software or interface to be used by the Follow-Up Unit to receive from the permittee the newborn screening test results and reports required in this chapter; and (2) Software programming assistance to ensure that the: (a) Permittee's data transmitted to the Follow-Up Unit is accurate and timely; and (b) The Follow-Up Unit's information system maintains compatibility with the permittee's information system. #### Regulation .26 Availability of Statistical and Scientific Data. *COMAR 10.10.13.26* A. Statistical Reports. The State’s public health laboratory, the Follow-Up Unit, or both, on request, shall provide Newborn Screening Program statistical data for official State and national reports to: (1) The Council; (2) The Department's Office of Genetics and Children with Special Healthcare Needs; and (3) State and federal agencies that use test results and statistics for the care and treatment of newborn infants. B. Research Investigations. The Laboratories Administration, the Follow-Up Unit, or both, may participate in research investigations approved by the Department's Institutional Review Board. #### Regulation .27 Sanctions. *COMAR 10.10.13.27* A. Due to the life-threatening nature and effect of errors in newborn screening testing, the Secretary may order summarily the suspension of a permit if the Secretary finds that the public health, safety, or welfare imperatively requires emergency action, including but not limited to, if a permittee has: (1) Failed to report a newborn infant's abnormal test result as required in this chapter; (2) Falsified a document submitted to the Department, including but not limited to a: (a) Newborn infant screening test report; or (b) Quality control or quality assurance report; or (3) Failed to provide a corrected or amended test report if the permittee has reported an erroneous or questionable test result. B. If the Secretary summarily suspends a permit as provided in §A of this regulation, the Secretary shall promptly give the permittee: (1) Written notice of the suspension, the finding, and the reasons that support the finding; and (2) An opportunity to be heard. C. The Secretary may impose a directed plan of correction, limit testing, deny a permit renewal, or suspend or revoke a current permit if a permittee has: (1) Failed to meet the applicable standards and requirements set forth in: (a) Health-General Article, Title 17, Annotated Code of Maryland; or (b) COMAR 10.10.01—.08 and this chapter; (2) Conducted research on newborn infant blood-spot specimens within the Newborn Screening Program’s approval as required in Regulation .15 of this chapter; or (3) Failed to pay the Department any fee required under this subtitle. D. In addition to sanctions provided in §§A and C of this regulation, the Secretary may: (1) Impose any sanction provided in COMAR 10.10.08; and (2) Refer a person for criminal prosecution, as provided at Health-General Article, §17-216, Annotated Code of Maryland. E. A person may have a hearing on the imposition of a sanction and an opportunity to respond to a sanction imposed by the Secretary under this regulation as set forth in COMAR 10.10.08.03. F. Except as provided in §§A and B of this regulation, before the Secretary denies, suspends, or revokes a permit, the Secretary shall give the applicant or permittee notice of the action and an opportunity to be heard.