Title: Section 55-2.4 - Approval criteria
55-2.4 Approval criteria.
(a) In such form as may be prescribed by the department, the environmental laboratory owner(s) and technical director(s) shall attest to the following:
(1) the laboratory will be operated in accordance with section 502 of the Public Health Law, the provisions of this Title and/or section 3-0119 of the New York State Environmental Conservation Law;
(2) the laboratory will employ approved methods and will document information pertinent to the approval, demonstration of capability, and use of each method;
(3) records will be maintained for not fewer than five (5) years and shall identify precisely the samples collected, accepted and examined; and procedures used and personnel involved; and shall document test conditions, observations and results of analyses, except that records of chemical analyses related to potable water supplies shall be maintained for not fewer than ten (10) years and records of analyses related to critical agents shall be maintained as required in section 55-2.13 of this Subpart; (4) the technical director(s) will develop, implement and document a quality system as defined in this Subpart; and
(5) the owner shall notify the department if the laboratory is found to be in violation of any federal, state or local law related to the provision of environmental laboratory services or reimbursement for such services, by the federal, state or local agency enforcing that law.
(b) Approval shall be granted to an environmental laboratory for the analytes by categories sought in the application for approval, provided: (1) the laboratory submits a complete application, including the attestation specified in subdivision (a) above and any additional information required by the department to support the application, and remits to the department the approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department; (2) each proposed technical director submits documentation of his or her qualifications for evaluation by the department, and the department finds such individual(s) qualified pursuant to section 55-2.10 of this Subpart;
(3) the laboratory provides documentation of a quality system in compliance with this Subpart; (4) pursuant to section 55-2.8, the laboratory participates and performs satisfactorily in proficiency testing for the analytes for which it seeks approval; (5) except as provided in subdivision (c) of this section, the laboratory undergoes an on-site assessment conducted by the department or by a state regulatory program recognized by the department pursuant to section 55-2.9; the findings of the on-site assessment(s) confirm compliance with the staffing, methodological and other requirements of this Subpart; and the laboratory demonstrates effective implementation of its quality system for planning and assessing the work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results; (6) the laboratory provides entry to representatives of the department and/or of a state regulatory program recognized by the department, for on-site assessments during normal business hours; and (7) the department finds the owner(s) and technical director(s) to be of good character and competence after evaluation of factors including, but not limited to:
(i) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or a technical director listed on the application, individually or jointly, or against any laboratory owned or directed by an owner or a technical director listed on the application, or findings by a municipality that a laboratory owned or directed by an owner or technical director listed on the application has violated a local ordinance relating either to collection and analysis of samples, or to reporting of results for the examination and said samples;
(ii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;
(iii) consideration of whether any environmental laboratory directed by the a technical director listed on the application has demonstrated a pattern of repetitive unsatisfactory performance in required proficiency testing in one or more proficiency testing categories, excluding an unsatisfactory score for administrative reasons such as late result submission;
(iv) consideration of whether any laboratory owned or directed by an owner or a technical director listed on the application has misrepresented any material fact pertinent to obtaining or retaining approval including, but not limited to, falsification of any report on or related to laboratory analysis, or submission of any reports on laboratory work, including work both on samples and proficiency testing, actually performed in another laboratory, without disclosing the fact that the examinations or procedures were performed in another laboratory; (v) evidence of aiding and/or abetting in the violation of any of the provision of this Subpart; and
(vi) any other factor having a direct bearing on the ability of the owner(s) and technical director(s) listed on the application to provide, direct or supervise the provision of high quality environmental laboratory services, or to ensure compliance with applicable statutory and regulatory requirements.
(c) Interim approval. (1) A laboratory that has not undergone an on-site assessment may be granted interim approval, for a period not to exceed twelve (12) months, provided all other requirements for approval in subdivision (b) above are met. (2) A laboratory with interim approval shall be granted full approval in the categories and analytes for which it seeks aprpoval provided the findings of on-stie assessment(s) as described in section 55-2.7 of this Subpart confirm compliance with the staffing, methodological and other requirements of this Subpart, and the laboratory demonstrates effective implementation of its quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results.
VOLUME A-1 (Title 10)