Title: Section 55-2.13 - Requirements for laboratories engaged in testing for critical agents in environmental samples

Effective Date

06/16/2010

55-2.13 Requirements for laboratories engaged in testing for critical agents in environmental samples.

(a) For purposes of this Subpart,
critical agentshall mean an organism, chemical element or chemical compound, which is recognized as posing a risk to national security and/or requiring special action to protect the public health because the agent: can be disseminated (e.g., in air, water or food) or transmitted person-to-person with ease; causes moderate to high mortality and/or morbidity; and can have a significant public health impact. The term organism includes, but is not limited to, a virus, bacterium, or product or component of an organism (e.g., a toxin).
Critical agentsshall include critical biological and chemical agents, including select agents, specified by the Federal Centers for Disease Control and Prevention (CDC) in published documents, and other such agents as the Commissioner of Health has determined meet the above criteria. The terms chemical element and chemical compound include substances that emit ionizing radiation including alpha, beta, gamma or neutron radiation.

(b) (1) Prior to performing testing for any critical agent in an environmental sample, a laboratory shall submit a request to the department, and receive an initial or revised certificate of approval that includes the specialty of critical agent testing and the approved method(s) the laboratory is authorized to employ as stipulated in sections 55-2.1 and 55-2.5 of this Subpart. The certificate of approval shall also list the specific critical agent(s) included in the approval, the approved method(s), and the types of samples (e.g., surface swipes, powder, air, fluid and bulk material) the laboratory may accept for testing. No laboratory shall examine an environmental sample for a critical biological agent or critical chemical agent without certification of approval specific to each critical agent for which testing is conducted.

(2) The department may withhold or limit its approval if the department is not satisfied that the laboratory has in place adequate policies, procedures, facilities, equipment, instrumentation and trained personnel to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of all environmental samples, derivatives and related materials shall be performed in a manner that: ensures consistently correct performance of the approved methods; ensures the protection of the health, safety and welfare of the laboratory's employees and the public; and is consistent with the requirements of this Subpart, and all other applicable laws, rules and regulations. The department shall also consider a laboratory's biosafety level facilities, safety practices, and its capability to assume an appropriate role in the public health and safety response(s) to critical agents, in its determination to approve the laboratory for critical agent testing in environmental samples.

(c) In addition to application and attestation requirements found elsewhere in this Subpart, a laboratory seeking approval to perform critical agent testing in environmental samples shall submit:

(1) a standard operating procedure manual documenting laboratory policies, procedures, facilities, equipment, supplies, instrumentation and personnel for critical agent testing, which are designed to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of all environmental samples, derivatives and related materials shall be performed in a manner that ensures consistently correct performance of the approved methods; ensures the protection of the health, safety and welfare of the laboratory's employees and the public; and is consistent with the requirements of this Subpart, and all other applicable laws, rules and regulations; and

(2) an attestation signed by the owner(s) and director(s) that the laboratory will accept only the type(s) of samples (e.g., surface swipes, powder, air, fluid and bulk material) specified on the laboratory's certificate of approval, and that the owner(s) and director(s) will take whatever action is necessary to ensure that such samples are collected, labeled, accessioned, prepared, analyzed, stored, transported, shipped and disposed of, and all results are reported in a manner consistent with the approved method and with all other documentation submitted to the department.

(d) In addition to meeting the preceding requirements of this Subpart, a laboratory engaged in critical agent testing in environmental samples, through its owner(s) and director(s), shall:

(1) establish, maintain, review periodically, and implement written policies and procedures designed to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of samples shall be performed in a manner that ensures consistently correct performance of the approved methods, ensures the protection of the health, safety and welfare of laboratory personnel, sample collectors and the public to the extent possible, and is consistent with all applicable laws, rules and regulations, as well as recognized standards of practice designed to minimize the risks associated with potential exposure to similar hazardous substances or critical agents. Such policies and procedures shall include specific procedures for containment, secured storage, decontamination, and/or disposal or destruction of the sample(s), derivatives, and related collection materials, supplies and/or equipment, as necessary and/or appropriate for the relevant suspected critical agent;

(2) have written policies and procedures in place to implement a chain-of-custody protocol whenever required by a law enforcement agency. Such policies and procedures shall be developed in consultation with law enforcement officials or other persons with appropriate experience and training in chain-of-custody issues, and shall at a minimum require an intact continuous record of the physical possession, storage, and disposition of the sample and any derivatives, including the signatures of all persons who access the sample and derivatives, the date of such access and other pertinent information;

(3) (i) ensure that all laboratory employees engaged in collecting and/or transporting environmental samples receive sufficient training in hazardous material handling techniques to ensure they will perform their responsibilities in a safe and reliable manner. Such training shall include, but not be limited to, training in sample collection, packaging, decontamination, transportation, and chain-of-custody policies and procedures established by the laboratory. The laboratory shall maintain documentation of such training for a minimum of three (3) years and take such other action as is necessary to ensure ongoing compliance with such policies and procedures;

(ii) develop and implement sample acceptance criteria designed to protect the health, safety and welfare of laboratory personnel, sample collectors, and the public to the extent feasible. Such criteria shall be consistent with approved methods for sample collection, handling, packaging and decontamination, and shall minimally define conditions under which a sample shall be rejected, and conditions under which a sample shall be tested and results reported with limitations. The laboratory shall make its sample acceptance criteria available to clients;

(4) issue reports of test results in a format and of a content required by the approved method, and necessary for interpretation of the test results or an autonomous detection system signal indicating the presence of a critical agent, including, but not limited to, unambiguous identification of the tested environmental sample, including collection location and time, source and sample type, and limitations of the method. The department may restrict a laboratory's ability to report information concerning a test result whenever confirmatory or supplemental testing is required by the approved method;

(5) report laboratory findings to the department or an authority designated by the department as soon as practicable, but no later than: (i) 24 hours following generation of a test result, via telephone, facsimile and/or electronic transmission, using a number or e-mail address designated by the department or the department's designee; and (ii) as specified in section 55-2.14 of this Subpart for an autonomous detection system, i.e., as soon as practicable but no later than one hour, whenever the findings indicate that an environmental sample contains an organism, its product or component, or a chemical, any of which exhibits characteristics or properties consistent with those of a critical agent. Whenever the department determines that supplemental testing is necessary, the laboratory shall submit all or part of the sample or its derivative(s) to the department or its designee, as directed by the department. For purposes of sections 55-2.13 and 55-2.14 of this Subpart, the term
supplemental testingshall mean performance of analyses following an initial indication that a critical agent has been detected, including, but not limited to, confirmatory testing and technical procedures to identify further the characteristics of a critical agent for public health protection and/or law enforcement purposes. The term
confirmatory testingshall mean supplemental testing that definitively substantiates or refutes the presence of a critical agent;

(6) unless precluded by law enforcement, prosecutorial or homeland security authorities, make available the findings of confirmatory testing conducted in response to an autonomous detection system signal to the approved laboratory operating the autonomous detection system; and

(7) establish and implement a critical agent inventory and tracking system that accounts for all environmental samples and their derivatives suspected or confirmed to contain critical agents. Unless required to demonstrate implementation of chain-of-custody procedures required pursuant to paragraph (2) of this subdivision or required by this paragraph, a laboratory may discontinue inventory and tracking of samples and derivatives, provided laboratory findings have established the absence of a critical agent. Inventory and tracking documentation shall include the identity of all individuals who access such materials and the date and time of access, as well as specific information regarding transfer, disposal or other disposition of the materials. Samples and their derivatives, access records, chain of custody records and records of the analyses performed shall be maintained in a secure manner until the statute of limitations for bringing any related criminal or civil action has expired, and the sample and its derivatives are no longer needed for evidence in any pending legal matter or by law enforcement officials. Access records, chain of custody records and records of the analyses of confirmed positive samples shall be maintained for ten (10) years, or as required above if longer.

(e) For critical biological agents, an environmental laboratory's proficiency testing performance shall be evaluated based on the known presence or absence of the critical agent, or, as applicable, its product or component. Satisfactory performance shall be a result correctly indicating the presence or absence of the critical agent, or, as applicable, its product or component. Unsatisfactory performance shall be a result incorrectly indicating the presence or absence of the critical agent, or, as applicable, its product or component.

(f) Personnel requirements for environmental sample testing for critical biological agents that are organisms shall be as follows:

(1) notwithstanding the requirements of section 55-2.10 of this Subpart, the environmental laboratory shall employ, as director, one of the following:

(i) a person who holds or meets the qualifications for a New York State clinical laboratory director certificate of qualification in the applicable subspecialty of microbiology (such as bacteriology), pursuant to Part 19 of this Title, and, for analyses using technologies other than conventional microbiologic techniques, at least one year of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by the polymerase chain reaction (PCR) technique). For purposes of this subdivision,
conventional microbiologic techniquesshall mean culture, use of differential media, stains and/or biochemical reactions, and morphologic examination of colonies and/or organisms;

(ii) a person with an earned doctoral degree or master's degree in the chemical, environmental, physical or biological sciences or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including: (a) at least one (1) course having microbiology as a major component, and at least one year of experience in analysis using one or more conventional microbiologic techniques for which the laboratory is approved or seeking approval; or (b) at least two years of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by PCR) for which the laboratory is approved or seeking approval; however, one course in the specific technology may be substituted for one year's experience; or

(iii) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including: (a) at least one (1) course having microbiology as a major component,

and at least two years of experience in analysis using one or more conventional microbiologic techniques for which the laboratory is approved or seeking approval; or (b) at least three years of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by PCR) for which the laboratory is approved or seeking approval; however, one course in the specific technology may be substituted for one year's experience; and

(iv) with respect to environmental laboratories that limit their critical biological agent testing to toxin analysis, any of the following personnel qualifications may be substituted for qualifications set forth above, as follows: a New York State clinical laboratory director certificate of qualification in toxicology may be substituted for the certification in microbiology requirement specified in subparagraph (i) of this paragraph; and coursework consisting of a minimum of sixteen (16) college semester credit hours in the biological and/or chemical sciences including at least (1) one course in biochemistry may be substituted for the coursework requirements, but not the educational degree requirements specified in clauses (ii)(a) and (iii)(a) of this paragraph; and

(2) with the exception of autonomous detection systems, sample preparation, analysis and related responsibilities shall be performed by an analyst who shall have an associate's degree or equivalent, with at least twelve (12) college semester credit hours in the biological sciences, and at least one year of experience in analysis of representative analytes; however, a person with at least three (3) years' experience in the analysis of representative analytes immediately preceding the effective date of this section shall be deemed to have met the requisite qualifications for performing critical agent analysis in the laboratory in which such experience has been obtained. Analysts with critical biological agent testing responsibilities that are limited to toxin sample preparation, analysis and related responsibilities may meet the semester credit hour qualifications set forth in this paragraph by completing a minimum of twelve (12) college semester credit hours in the biological and/or chemical sciences.

(g) This section shall not apply to bacteriologic testing for total and fecal coliform bacteria (i.e., the common form of
Escherichia coli) in potable and non-potable water.

Volume

VOLUME A-1 (Title 10)

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