This chapter establishes training and certification criteria of personnel performing tests of breath and blood for the purpose of determining the alcohol content of drivers suspected of driving while impaired or under the influence of alcohol and approval and certification criteria for equipment used in conducting these tests. In this chapter, the following terms have the meanings indicated. Terms Defined. “Agency” means any law enforcement agency approved to test breath or blood for alcohol content. “Alcohol” means ethyl alcohol (ethanol). “Alcohol calibration solution” means a water solution containing a range of certified, specific concentrations of ethanol from 0.02 to 0.500 gram/deciliter for the purpose of ethanol quantitation. “Alcohol control solution” means a water solution containing a certified, specific concentration of ethanol. “Alcohol gas standard” means a container of compressed gas containing a specific concentration of alcohol. “Alcohol reference solution” means a water solution containing a specific concentration of alcohol. “Breath sample” means the amount of breath delivered by the individual being tested that is an adequate volume to be analyzed by the breath testing instrument. “CTAU” means the Chemical Test for Alcohol Unit within the Department of Maryland State Police. “CTAU supervisor” means the individual designated by the Commander or Director of CTAU and approved by the Toxicologist to supervise the CTAU. “Preliminary breath testing (PBT) device” means a portable, roadside screening device approved by the Toxicologist, pursuant to Transportation Article, §16-205.2, Annotated Code of Maryland, for use on individuals stopped for suspicion of driving while impaired or under the influence of alcohol. “Qualified medical person” means an individual permitted by any state to withdraw blood from humans. “Qualified person” has the meaning stated in Courts and Judicial Proceedings Article, §10-304, Annotated Code of Maryland. “Representative of the Toxicologist” means any employee supervised by the Toxicologist or an employee of the Department of State Police designated by the Toxicologist to act as the authorized representative of the Toxicologist. “Toxicologist” means the Chief Toxicologist or State Toxicologist in the Department of State Police Forensic Sciences Division. “Validation test” means a test of specific alcohol concentration used to verify the calibration of a breath testing instrument. Alcohol Concentration of Breath. The alcohol concentration of breath shall be reported as grams of alcohol per 210 liters of breath (gram/210 liters). Alcohol Concentration of Blood. The alcohol concentration of blood shall be reported as grams of alcohol per 100 milliliters of blood (gram/100 milliliters). Uncertainty. For breath tests for alcohol content, the accepted scientific uncertainty in measurement is plus or minus 0.005 gram/210 liters or 10 percent of the average of measurements, whichever is greater. For blood tests for alcohol content, the accepted scientific uncertainty in measurement is plus or minus 0.005 gram/100 milliliters or 10 percent of the average of measurements, whichever is greater. PBT Devices. The Toxicologist shall: Approve the make and model of PBT devices used in the State; and Maintain a list of approved make and model PBT devices. At the time of approval by the Toxicologist, the make and model of the PBT device shall be on the most recently updated Conforming Products List of Evidential Breath Alcohol Measurement Devices published in the Federal Register by the National Highway Traffic Safety Administration of the Department of Transportation. Calibration Check. The calibration of a PBT device shall be checked by a PBT device operator, trained in accordance with §B(1) of this regulation, once a month by using an approved alcohol reference solution or alcohol gas standard. The results of the calibration check shall be within plus or minus 10 percent, inclusive, of the alcohol concentration of the alcohol reference solution or alcohol gas standard. A PBT device that does not achieve the result specified in §A(3)(b) of this regulation shall be withdrawn from use until it has been recalibrated. Training Programs. PBT Device Operator Training Program. The Toxicologist shall approve a PBT device operator training program. CTAU shall be notified in advance of all PBT device operator training classes. A preliminary breath test of an individual suspected of being impaired or driving under the influence of alcohol or drugs shall be conducted only by a law enforcement officer who has completed and passed this training. A written exam consisting of at least 25 questions shall be given at the conclusion of the program. The cumulative passing score shall be 70 percent or above. A roster of students successfully completing the course shall be forwarded to the CTAU on completion of the program. PBT Device Instructor Training Program. All PBT device operator classes shall be taught by individuals who have successfully completed a PBT device instructor training program from CTAU. CTAU shall provide instructor training for all agencies. Any requests for PBT Device Instructor Training shall be made to the CTAU Supervisor. The PBT device instructor training program shall: Include at least 16 hours of instruction; and Be approved by the Toxicologist. CTAU shall issue a certificate after the successful completion of either program outlined in §B(1) or (2) of this regulation. Testing Agencies. An agency desiring approval to conduct evidentiary breath tests shall make a written request to the CTAU Supervisor. An agency requesting approval to conduct breath tests shall: Offer 24-hour law enforcement service; Provide an environmentally controlled area and a phone line exclusively for the breath testing instrument; Provide expendable supplies needed for personnel to operate the equipment; and Have a minimum of 20 full-time sworn law enforcement officers. An agency shall have a breath test supervisor who shall administer and coordinate all alcohol testing related activities with CTAU. The breath test supervisor shall be a breath test operator. An agency’s approval to conduct breath testing may be withdrawn by the Toxicologist or their representative based on: A substantial failure to comply with this chapter; or Inadequate State resources. Training Programs. Basic Breath Test Operator Certification Course. All basic breath test operator courses shall be: Approved by the Toxicologist; and Taught by approved breath test instructors. The course shall include a minimum of 35 hours of lecture or laboratory instruction covering: A study of the mathematics of the metric system; A study of the properties, human physiology, and pharmacology of alcohol; A study of the theory, operating principles, and maintenance requirements of the breath test instruments; and A review of relevant Maryland statutes, regulations, and cases affecting enforcement and testing of an individual suspected of driving while impaired or under the influence of alcohol. A written examination consisting of at least 50 questions shall be given at the conclusion of the course. The cumulative passing score on the written examination shall be 90 percent or above. The individual shall demonstrate to the instructor satisfactory ability to use the instrument. Breath Test Operator Certification Renewal Course. A breath test operator certification renewal course shall be: Approved by the Toxicologist; and Taught by approved breath test instructors. The course shall be comprised of a minimum of 6 hours of instruction, including a review of: Breath testing theory; Methods and procedures; and Current and contemporary issues. A written examination consisting of at least 25 questions shall be given at the conclusion of the course. The passing score on the written examination shall be 80 percent or above. Breath Test Maintenance Technician Course. The breath test maintenance technician course shall be approved by the Toxicologist. This course shall include a minimum of 70 hours of training, covering: A review of breath testing theory, methods, and developments; Operation, takedown, and maintenance of instruments; Gas cylinder replacement; and Simulator takedown, maintenance, and solution changing. A written or oral exam shall be administered by the CTAU Supervisor before certification. CTAU shall issue a certificate after the successful completion of any course outlined in §B(1) — (3) of this regulation. Breath Test Operator. Initial Certification as a Qualified Person. To become a qualified breath test operator, a qualified person shall be: A full-time law enforcement officer of an agency approved to conduct breath tests; A full-time laboratory technician of an agency approved to conduct breath tests; or Any individual designated by the Toxicologist. CTAU shall issue an initial certificate after the successful completion of a basic breath test operator course as described in Regulation .05B(1) of this chapter. An initial certification shall be valid for a period of 15 months. Renewal of Certification. Before expiration of the initial certification or each subsequent renewal certification period, a breath test operator shall: Exhibit competence in the performance of all duties as a breath test operator as described in Regulation .07A(1) of this chapter; and Successfully complete a breath test operator certification renewal course as outlined in Regulation .05B(2) of this chapter. CTAU shall issue a renewal certificate after the breath test operator complies with §A(2)(a) of this regulation. A renewal certificate shall extend certification for an additional period of 13 months. Reinstatement of Expired Certification. If the breath test operator's certification expires and not more than 90 days have elapsed since the time of expiration, the CTAU supervisor may reinstate the operator. If more than 90 days but less than 3 years have elapsed, the CTAU supervisor: Shall confer with the Toxicologist or their representative about reinstatement; and May require a demonstration of proficiency before reinstatement of the expired certification. A breath test operator who applies for reinstatement more than 3 years following expiration of certification shall complete the basic breath test operator course as provided in Regulation .05B(1) of this chapter to be requalified. Suspension and Revocation of Certification. An individual who fails a breath test operator certification renewal course shall be immediately suspended by the CTAU as a breath test operator. The CTAU supervisor may issue a renewal certificate to an individual if the breath test operator certification renewal course is successfully completed within 120 days of the initial failure. The CTAU supervisor may suspend or revoke a certificate of a breath test operator if, in the supervisor's judgment, the individual’s performance is unsatisfactory. If the individual’s certificate is revoked, the individual shall return all certificates and manuals to the CTAU supervisor. Breath Test Maintenance Technician. To become a breath test maintenance technician, an individual shall: Be an employee of CTAU; Have successfully completed an approved operator and maintenance course for breath testing instrumentation as described in Regulation .05B(3) of this chapter; and Demonstrate proficiency in the use of breath testing instrumentation to: The CTAU supervisor; or An approved instructor. CTAU shall issue a certificate if: The individual complies with §B(1) of this regulation; and The Toxicologist approves of the issuance of the certificate. Certification of a breath test maintenance technician may be suspended or revoked for the following reasons: Failure to properly maintain breath testing instruments; or Failure to adhere to this chapter. Breath Test Instructor. To become a breath test instructor, an individual shall: Successfully complete the training programs described in Regulation .05B of this chapter; Have prior experience in training law enforcement officers; Assist in at least one basic breath test operator course as referenced in Regulation .05B(1) of this chapter; and Be approved by the Toxicologist. A breath test instructor may perform any instrument maintenance and repair as needed. Breath Test Operator. A breath test operator shall: Perform breath tests for alcohol in accordance with training; Perform at least one test per month, either a subject or simulation test; Notify CTAU of the following: Test results that deviate greater than plus or minus 10 percent of the stated concentration for any validation test; or Mechanical problems with the breath testing instrument; and Complete all required reports. A breath test operator who fails to perform at least one test per month as required in §A(1)(b) of this regulation shall provide a reason for this failure to the CTAU supervisor. If a breath test operator will be on extended leave from the agency, the CTAU supervisor shall be notified by the breath test operator or the agency breath test supervisor. Breath Test Maintenance Technician. A breath test maintenance technician shall: Set up all instruments in the field; Conduct an inspection of the assigned breath testing instruments at least once a month; Conduct all scheduled maintenance procedures; Change the alcohol gas cylinder or alcohol reference solution as needed; Test each instrument with approved alcohol gas standard or alcohol reference solution at least once a month; Remove an instrument from service if the result of the test in §B(5) of this regulation is not plus or minus 10 percent of the stated concentration; Repair the instrument as needed; and Complete all required reports. Breath Testing Instruments. The Toxicologist shall approve all instruments to be used in the State for the purpose of testing breath for alcohol content pursuant to Courts and Judicial Proceedings Article, §§10-302 and 10-304, Annotated Code of Maryland. An agency shall only use an instrument that has been approved by the Toxicologist. An individual may receive a copy of the list of the manufacturers and models of currently approved instruments from the Department of State Police Forensic Sciences Division at no charge. Certification of Approval of Instruments. The Toxicologist shall certify approval of each instrument before it is used in the State. At the time of approval by the Toxicologist, the instrument shall be on the most recently updated Conforming Products List of Evidential Breath Alcohol Measurement Devices published in the Federal Register by the National Highway Traffic Safety Administration of the Department of Transportation. On at least an annual basis, the Toxicologist or their representative shall recertify approval of each instrument. Following successful testing, an instrument that is repaired by a certified breath test maintenance technician may be returned to service without the recertification of approval by the Toxicologist. Inspection. Approved equipment and related records shall be available for inspection by the Toxicologist or representative at all times. Validation Tests. The Toxicologist shall approve the alcohol reference solution or alcohol gas standard to be used as validation tests. Validation tests shall be performed contemporaneously with each evidentiary breath test using an approved alcohol reference solution or alcohol gas standard. Initial Certification of Instrument Approval. Precision and Accuracy Testing. Vapor containing 0.020 gram/210 liters, 0.040 gram/210 liters, 0.080 gram/210 liters, and 0.160 gram/210 liters ethanol concentrations shall be introduced through the breath tube of the instrument. Each concentration shall be repeated four times. As an indication of precision, the combined average standard deviation shall be not greater than 0.0042 gram/210 liters. As an indication of accuracy, systematic variations at each ethanol concentration will be calculated and shall be not more than 5 percent or 0.005 gram/210 liters, whichever is greater. Any instruments not meeting the precision and accuracy requirements may not be approved. Acetone Detection Testing. Vapor containing 0.020 gram/210 liters ethanol and 100 microliters of acetone per 500 milliliters solution shall be introduced through the breath tube of the instrument. Each concentration shall be repeated four times. The instrument shall read between 0.015 and 0.025 gram/210 liters. An instrument not meeting the requirement for acetone detection may not be approved. Blank Testing. Four samples of vapor containing no ethanol or other solvents shall be introduced through the breath tube of the instrument. No reading shall exceed 0.005 gram/210 liters vapor. An instrument not meeting the blank detection requirement may not be approved. If conditions outlined in §E(1) — (3) of this regulation are met: The instrument shall be approved; and The Toxicologist shall issue a letter certifying instrument approval. Periodic Recertification of Approval. Instrument approval shall be recertified at least annually. The Toxicologist shall issue a letter recertifying instrument approval. Evidentiary Breath Test Method. For at least 20 minutes before a breath sample is taken, an individual may not: Eat or drink; Have any foreign substance in the individual’s mouth or respiratory tract; or Smoke. The individual shall be observed and mouth checked. Observation of the individual shall be performed by: A breath test operator; Other uniformed or civilian law enforcement personnel; or Any combination of a breath test operator and uniformed or civilian law enforcement personnel. The testing procedure shall begin with a blank test to ensure that no alcohol is present in the breath path of the breath testing instrument. A validation test shall be run before the individual begins the testing process. If the breath testing instrument fails to obtain a reading plus or minus 10 percent of the stated alcohol concentration on the validation test, then the subject test shall be discontinued. The individual shall be instructed to take a breath and then deliver a breath sample into the instrument by blowing into the mouthpiece and breath tube until instructed to stop. After each subject breath sample, a blank check shall be performed to ensure that no alcohol is present in the breath path. Two breath samples shall be collected and analyzed by the breath testing instrument. A third breath sample shall be collected only if the absolute difference between the results of the first and second samples exceeds 0.020 gram/210 liters. A validation test of known alcohol concentration shall be run after the individual has given the required number of breath samples. If the instrument fails to obtain a reading plus or minus 10 percent of the stated concentration on the validation test, then the subject test is invalid. The lower of the two or lowest of the three results of the subject test shall be truncated to the second decimal place and reported as the result of the breath test. Laboratories and Procedures for Analysis. Laboratories. The Department of Maryland State Police Forensic Sciences Division is an approved laboratory to conduct tests of blood for alcohol. Approval by the Toxicologist of any other laboratory is required before it may perform any test of blood for alcohol in accordance with Courts and Judicial Proceedings Article, §10-304, Annotated Code of Maryland. An individual may receive a copy of the list of currently approved laboratories from the Department of Maryland State Police Forensic Sciences Division at no charge. Equipment and Procedures for Analysis. The Toxicologist shall approve all equipment and analytical procedures for the testing of blood for alcohol. Approved equipment shall be calibrated with alcohol calibration solution or solutions approved by the Toxicologist. The calibration shall be checked using an alcohol control solution. Alcohol control solution test results may not deviate greater than plus or minus 0.010 gram/100 milliliters from its stated concentration. The laboratory shall perform evidentiary tests of blood for alcohol in duplicate and the duplicate results may not deviate greater than plus or minus 0.010 gram/100 milliliters. For subject tests, the lower of the duplicate results shall be truncated to the second decimal place and reported as the result of the blood test. Personnel. Qualified Medical Personnel. Any qualified medical person is approved to withdraw blood for the testing of blood for alcohol content. Analyst. The Toxicologist shall certify an analyst performing tests of blood for alcohol content as a qualified person. The Toxicologist shall: Review the credentials of the analyst; Direct a program of training as necessary; and Set standards for maintenance of proficiency. The Toxicologist shall recertify the analyst on a regular basis. A certified analyst shall perform at least one batch of subject specimens or proficiency specimens annually. Procedures for Administering an Evidentiary Test of Blood for Alcohol. The blood specimen shall be withdrawn by qualified medical personnel. Blood sampling equipment shall be approved by the Toxicologist. The arresting officer or another law enforcement officer may witness the withdrawal of the blood. The law enforcement officer shall: Fill out all forms contained in the approved blood sampling equipment kit; and Be certain all seals are signed and properly affixed. The sample shall be delivered by messenger or mail to the Department of Maryland State Police in containers provided with the sampling equipment. Courts and Judicial Proceedings Article, §§10-304 and 10-306; Health-General Article, §17-214(g); Public Safety Article, §2-205; Transportation Article, §2-205; Annotated Code of Maryland Effective date: Regulations .01—.09 adopted as an emergency provision effective February 20, 2023 (50:7 Md. R. 297); expired effective July 21, 2023 New Regulations .01 — .09 adopted effective November 25, 2024 (51:23 Md. R. 1038)