reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.09 - Forensic Laboratories - Personnel Certification and Approval of Laboratory Procedures › Section 10.10.09.03 - Employment, Employment Certification, and Automatic Decertification

Current through Register Vol. 51, No. 14, July 12, 2024
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 of 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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.09 - Forensic Laboratories - Personnel Certification and Approval of Laboratory Procedures › Section 10.10.09.04 - Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.09 - Forensic Laboratories - Personnel Certification and Approval of Laboratory Procedures › Section 10.10.09.05 - Report

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.04 - Responsibilities of the Secretary

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.05 - Employer Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.06 - Permissible Specimens

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.07 - Specimen Collection and Handling Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.08 - Protections for Job Applicants, Employees, and Contractors

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.09 - Confidentiality

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.10 - Job-Related Alcohol and Controlled Dangerous Substances Testing › Section 10.10.10.10 - Preliminary Screening by an Employer or Agent of the Employer

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.03 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.04 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.05 - Registering Under the Biological Agents Registry Program

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.06 - Compliance with Federal Standards

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.07 - Responsibilities of the Department

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.08 - Responsible Official; Alternate Responsible Official

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.09 - Reporting Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.10 - Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.11 - Reporting of Unauthorized Activities

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.12 - Biological Agent Incident Response Plan

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.13 - BAR Information Confidentiality and Release of BAR Information

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.14 - Method of Non-Emergency Release of BAR Information

Current through Register Vol. 51, No. 14, July 12, 2024
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).
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.15 - Release of BAR Information to Law Enforcement Agencies and CDC

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.16 - Release of BAR Information to Local Jurisdictions

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.17 - Release of BAR Information to MDE, MEMA, and MIEMSS

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.18 - BAR Information Updates

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.19 - BAR Information Security Standards - General

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.20 - BAR Information Security Standards - Administrative Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.21 - BAR Information Security - Physical Safeguards

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.22 - BAR Information Security - Technical Security Measures

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.11 - Biological Agents Registry Program › Section 10.10.11.24 - Penalties

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
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
				  Department of Health and Mental Hygiene.
(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
				  10.10.01.03BB
				  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
				  10.10.01.03BB
				  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
				  10.10.01.03BB
				  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) Is a
				  single-use test device as defined in COMAR
				  10.10.01.03B;
(b) Uses whole blood as the specimen to
				  detect hepatitis C antibodies;
(c)
				  Is waived under the CLIA program; and
(d) Provides a test result while the
				  individual being tested is waiting.
(9) "Rapid HIV antibody test" means a public
				  health HIV test that:
(a) Is a single-use test
				  device as defined in COMAR
				  10.10.01.03B;
(b) Uses whole blood or oral fluid as the
				  specimen to detect HIV antibodies;
(c) Is waived under the CLIA program;
				  and
(d) Provides a test result
				  while the individual being tested is waiting.
(10) "Secretary" means the Secretary of
				  Health and Mental Hygiene.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.03 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.04 - Public Health Testing License for Rapid HTV Antibody Testing and HCV Testing

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.05 - Quality Assessment Plan and Quality Control Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.06 - Personnel Training and Competency

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.07 - Standard Operating Procedures Manual

Current through Register Vol. 51, No. 14, July 12, 2024
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
				  10.18.08.10CC and
				  10.18.09.07C.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.08 - Public Health Testing Program Director

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.09 - Manufacturer's Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs › Section 10.10.12.10 - Confirmatory Test

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
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
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.03 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.04 - Permit

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.05 - Inspection Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.06 - Fees

Current through Register Vol. 51, No. 14, July 12, 2024
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 $106 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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.07 - Director Requirement, Qualifications, and Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
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
				  10.10.07.04C;
				  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.