Maryland Administrative Code

.04 Responsibilities of the Secretary. 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 eac…

.05 Employer Requirements. 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 cont…

.06 Permissible Specimens. 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)…

.07 Specimen Collection and Handling Procedures. 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 ta…

.08 Protections for Job Applicants, Employees, and Contractors. 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 w…

.09 Confidentiality. 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 receive…

.10 Preliminary Screening by an Employer or Agent of the Employer. 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…

.01 Purpose. 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.

.02 Scope. 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 …

.03 Definitions. 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 B…

.04 Incorporation by Reference. 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, “Bios…

.05 Registering Under the Biological Agents Registry Program. 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 Departmen…

.06 Compliance with Federal Standards. 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 an…

.07 Responsibilities of the Department. 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, ini…

.08 Responsible Official; Alternate Responsible Official. 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 respon…

.09 Reporting Requirements. 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: (…

.10 Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent. 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 c…

.11 Reporting of Unauthorized Activities. 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 biolo…

.12 Biological Agent Incident Response Plan. 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…

.13 BAR Information Confidentiality and Release of BAR Information. 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 chapte…

.14 Method of Non-Emergency Release of BAR Information. 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…

.15 Release of BAR Information to Law Enforcement Agencies and CDC. 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 diseas…

.16 Release of BAR Information to Local Jurisdictions. 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 maint…

.17 Release of BAR Information to MDE, MEMA, and MIEMSS. 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, an…

.18 BAR Information Updates. 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 f…

.19 BAR Information Security Standards — General. 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 Depar…

.20 BAR Information Security Standards — Administrative Procedures. 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 t…

.21 BAR Information Security — Physical Safeguards. 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 …

.22 BAR Information Security — Technical Security Measures. 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 …

.23 Trusted Partner Agreement. 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…

.24 Penalties. 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…

.01 Scope. 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 publ…

.02 Definitions. 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 …

.03 Incorporation by Reference. 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.

.04 Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing. 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 …

.05 Quality Assessment Plan and Quality Control Requirements. 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 …

.06 Personnel Training and Competency. 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 Co…

.07 Standard Operating Procedures Manual. 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.…

.08 Public Health Testing Program Director. 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 tes…

.09 Manufacturer's Requirements. 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…

.10 Confirmatory Test. 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. Collec…

.01 Purpose. 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 …

.02 Scope. 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…

.03 Definitions. 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 re…

.04 Permit. 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…

.05 Inspection Requirements. 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. Inspecti…

.06 Fees. 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 …