Title: Section 55-2.14 - Additional requirements for laboratories engaged in testing for critical agents in environmental samples using autonomous detection systems
55-2.14 Additional requirements for laboratories engaged in testing for critical agents in environmental samples using autonomous detection systems.
(a) For purposes of this Subpart
(1) autonomous detection systemshall mean a fixed or portable self-contained analytical system that: automatically, continuously or periodically samples the environment; analyzes sample(s); and triggers an alert that a critical agent, as defined in section 55-2.13 of this Subpart, has been detected. For purposes of Subpart 55-2, signaland alertshall have the same meaning, i.e., a visual and/or audio alert triggered whenever an organism, its product or component, or a chemical, any of which exhibits characteristics or properties consistent with those of a critical agent has been detected by the detection system;
(2) deployand operateshall mean to engage the system in real time collection and analysis of environmental samples for purposes of detecting incidental release of a critical agent as defined in section 55-2.13 of this Subpart;
(3) autonomous detection systemshall not mean a device for environmental sampling and/or analysis of environmental samples deployed for a purpose other than detecting incidental release of a critical agent as defined in section 55-2.13 of this Subpart. Accordingly, the provisions of this Subpart shall not be applicable to;
(i) carbon monoxide detectors;
(ii) radon detectors;
(iii) hand-held detectors, personal dosimeters or Geiger counters designed and intended for use by individuals, or, when used in an academic setting, for instruction or research;
(iv) detectors deployed within hospitals or other health care facilities;
(v) detectors deployed by utility companies or in an industrial setting for the purpose of monitoring internal air quality or detecting leakage of hazardous materials;
(vi) detectors deployed by certified industrial hygienists, labor unions and other individuals or entities responsible for or engaging in testing or monitoring of workplace or environmental safety, including such testing or monitoring in the aftermath of a possible accident or bioterrorism incident involving critical agent(s); and
(vii) an environmental sampling and/or testing device deployed for a purpose other than detecting the incidental release of a critical agent, and determined by the Commissioner of Health to not require department oversight pursuant to Public Health Law Section 502.
(b) In addition to meeting the requirements stipulated elsewhere in this Subpart, including the department's Quality System Standards as referenced in Section 55-2.1(f), a laboratory engaged in the analysis of environmental samples using an autonomous detection system shall:
(1) ensure that the system is operated in a secure and safe manner to prevent accidental or deliberate tampering that could compromise the integrity of its operation;
(2) establish and validate the minimum concentration(s) of specified critical agent(s) that would trigger a signal;
(3) develop a laboratory response plan acceptable to the department, to be immediately implemented whenever a signal is triggered, that at a minimum includes procedures for: notification of a signal to the client(s) on whose property an autonomous detection system is situated;
notification of a signal to state and local public health and emergency preparedness authorities responsible for confirming, responding to and remediating an incident involving critical agent(s); emergency shutdown of any autonomous detection system suspected to be malfunctioning; communication between the laboratory's technical director and authorities responding to a signal; timely verification that any signal triggered was neither a false positive nor false negative signal, including review of results of any supplemental testing; and remediation for any false signal;
(4) retain documentation that the response plan has been developed in collaboration with:
(i) state public health and emergency preparedness authorities, and comparable local authorities whenever applicable, responsible for confirming, responding to and remediating an incident involving critical agent(s); and includes documentation of approval by state and/or local public health and emergency preparedness authorities. Such documentation shall include a valid permit or certificate authorizing deployment of an autonomous detection system within an area under the authority's jurisdiction; and
(ii) the client(s) on whose property an autonomous detection system is situated and other party(ies) situated at or controlling right of access at that location; and includes an attestation of agreement to follow response plan protocols, signed by the client and any party(ies) situated at or controlling right of access at the location at which the autonomous detection system is deployed;
(5) document, in its standard operating procedures manual:
(i) the laboratory's process for selecting locations in which autonomous detection systems are to be situated, or, if a system is portable, a description of the types of locations in which a system may be deployed;
(ii) procedures to ensure adequate oversight by the technical director of each autonomous detection system deployed by the laboratory, including, but not limited to, review of quality assurance and quality control data and, as available, the results of any postsignal confirmatory testing;
(iii) protocols for monitoring multiple systems or monitoring from a remote location;
(iv) protocols for timely communication between the system's operator and the technical director, and between the client and the laboratory; and
(v) the laboratory's response plan.
(6) for each autonomous detection system in operation: maintain records on its location, including street address, and a description of its exact placement within a building or area
(7) whenever the system triggers an alert:
(i) immediately follow procedures prescribed in the laboratory's response plan;
(ii) as soon as practicable, but no later than one hour after a signal has been triggered, notify the department or an authority designated by the department, via telephone using a number designated by the department or the department's designee; and document the date and time of the telephone call, and the name(s) of the responsible person(s) contacted; and
(iii) request for review records of any supplemental testing conducted in response to the triggered signal. Whenever the results of such supplemental testing are inconsistent with the expected reason for a signal, the laboratory shall render inoperable the autonomous detection system that triggered the signal until the cause of the discrepancy is determined and remediated.
(c) The laboratory shall maintain a fixed-base location at which all records required by this Subpart, including but not limited to, calibration, test, quality assurance, quality control, operator training, and client notification protocols and supplemental testing are retained for periods stipulated in this Subpart. The laboratory shall also retain records demonstrating compliance with federal, state, and local rules for registration, use and disposal of any material that meets the definition of a biological or chemical critical agent, including radioactive material, in its possession.
(d) A laboratory may operate one or more autonomous detection systems under the direction of one technical director. Procedures for direct oversight by the technical director of one or more systems and their operator(s) shall be acceptable to the department.
(e) An autonomous detection system, while in operation, shall be continuously monitored by an autonomous detection system operator who functions under the direction of the technical director. The technical director may also serve as the operator. Prior to designating a person as an autonomous detection system operator, the laboratory owner and technical director shall ensure compliance with applicable personnel requirements stipulated in the department's Quality System Standards as referenced in Section 55-2.1(f), as well as ensure that the operator:
(1) receives adequate training specific to the operation of each specific make and model of autonomous detection system in use by the laboratory;
(2) provides written attestation to reading and understanding the general policies and procedures of the laboratory, and those specific to the autonomous detection system(s) in use, including the laboratory's response plan and the operator's responsibilities under that plan; and
(3) undergoes a successful demonstration of capability that includes participation in the mock implementation of each specific response plan for each autonomous detection system deployed by the laboratory.
VOLUME A-1 (Title 10)