Header:
CODE OF MARYLAND REGULATIONS
TITLE 10. DEPARTMENT OF HEALTH AND MENTAL HYGIENE
SUBTITLE 10. LABORATORIES
CHAPTER 11. BIOLOGICAL AGENTS REGISTRY PROGRAM
Date:
08/31/2009
Document:
.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 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 Biological Agents Registry Program.
E. The Biological Agents Registry Program may release BAR information only to:
(1) State and federal law enforcement agencies;
(2) CDC; and
(3) BAR information custodians of trusted partners.
F. Before the Biological Agents Registry Program releases BAR information to a person, except State and federal law enforcement agencies and the CDC, 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 Biological Agents Registry Program for approval.
G. Mutual Aid Response. When multiple local jurisdictions respond to an emergency, the emergency management director of one responding jurisdiction may share BAR information with an emergency management director from another local 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 Biological Agents Registry 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:
(i) Experiences a BAR information computer information system malfunction; or
(ii) Otherwise 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:
(a) Has a computer information system failure or other incident that prevents access to BAR information; or
(b) 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 breach in containment of a biological agent or there is an imminent threat of a breach of containment;
(2) The breach or imminent threat of a breach is confirmed by the:
(a) Responsible official; or
(b) Emergency public safety personnel at the scene of the emergency response; 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 as described in § J of this regulation, the:
(a) Public safety personnel responding to an emergency shall contact the public safety personnel's 9-1-1 center; and
(b) 9-1-1 center personnel shall notify the:
(i) Emergency management director;
(ii) Health officer; and
(iii) MIEMSS.
(2) When MIEMSS receives notice of a breach or an imminent threat of a breach of containment of a biological agent, MIEMSS shall notify:
(a) The Department's:
(i) Physician on-call; and
(ii) Office of Laboratory Emergency Preparedness and Response;
(b) MDE; and
(c) MEMA.
(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 Biological Agents Registry Program, a trusted partner shall notify the Biological Agents Registry 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.
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