Title: Section 55-2.6 - Denial, suspension and revocation of department approval

55-2.6 Denial, suspension and revocation of department approval.

(a) The department may deny an environmental laboratory’s application for a certificate of approval for the following reasons:

(1) except as provided in section 55-2.4(c), failure to undergo an on-site assessment conducted by the department or by a state program recognized by the department pursuant to section 55-2.9 of this Subpart or failure to demonstrate, during any on-site assessment so conducted: compliance with the staffing, methodological and other requirements of this Subpart; and effective implementation of a 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;

(2) failure to participate or perform satisfactorily in proficiency testing pursuant to section 55-2.8 of this Subpart for the analytes for which the laboratory seeks approval;

(3) failure of the laboratory technical director(s) to meet the required qualifications in section 55-2.10 of this Subpart;

(4) misrepresentation of any material fact pertinent to obtaining or retaining approval for any laboratory owned or directed by an owner or technical director listed on the application including, but not limited to, falsification of any report on or related to a laboratory analysis or submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(5) failure to submit a complete approval application, including the attestation required in section 55-2.4(a) of this Subpart, or failure to provide documentation of a quality system as defined in this Subpart or any additional information required by the department to support the application;

(6) failure to remit the required fees;

(7) the owner(s) and/or technical director(s) listed on the application are determined by the department to lack the character and competence necessary to ensure compliance with the applicable laws, rules and regulations after consideration of factors including but not limited to:

(i) evidence of aiding and/or abetting in violation of any of the provisions of this Subpart;

(ii) 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, individually or jointly, or against any laboratory owned or directed by an owner or technical director listed on the application, or a finding by a municipality that a laboratory has violated a local ordinance related to collection and analysis of samples or specimens, or to reporting of results for examination of said samples or specimens;

(iii) 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;

(iv) consideration of whether any environmental laboratory directed by 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; and/or

(v) 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;

(8) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(9) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(10) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe; and/or

(11) denial of entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart, for on-site assessment during normal business hours.

(b) (1) If the department proposes to deny an environmental laboratory’s application for a certificate of approval, the laboratory shall be given written notice of the proposed denial, stating the reason or reasons for such proposed denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice, unless reconsideration is requested;

(2) if the department gives notice of proposed denial, the laboratory may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within thirty (30) days of the date of the notice of proposed denial. Submission of a request for reconsideration within thirty (30) days shall stay any action to deny a laboratory's application for a certificate of approval, pending the department’s decision regarding such request for reconsideration;

(3) the written request for reconsideration shall be signed by the owner(s) and technical director(s), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the denial or disclose that the denial was based upon a mistake of fact;

(4) if the laboratory properly seeks reconsideration of the proposed denial, the department shall review its proposed denial and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed denial, allow issuance of a certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(c)(1) An environmental laboratory’s certificate of approval shall be suspended automatically upon a change in laboratory ownership, technical direction, or location. However, provided re-application has been made in writing to the department within thirty (30) calendar days of the change, the department may extend an environmental laboratory’s certificate of approval for a period not to exceed ninety (90) calendar days after any change in laboratory ownership, technical direction or location, in order to permit the department to evaluate, as applicable, the character and competence of the new technical director(s) and/or new owner(s) considering requirements in section 55-2.4(b) of this Subpart; the qualifications of the new technical director(s); and/or the effect of the change in location on the environmental laboratory’s ability to produce accurate and reliable analytical data.

(2) An environmental laboratory’s certificate of approval shall be suspended automatically upon failure to remit at least the quarterly payment of the annual approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department.

(3) An environmental laboratory’s certificate of approval shall be suspended automatically, in affected analytes and/or categories, for failure to maintain a record of at least two (2) satisfactory proficiency testing (PT) events within the three (3) most recent PT events.

(4) (i) The department may suspend an environmental laboratory’s certificate of approval, in affected analytes and/or categories, for reasons including:

(a) a pattern of deficiencies on on-site assessment or other demonstration that the laboratory lacks an effective 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; and

(b) failure to notify the department of any change in major analytical instrumentation within thirty (30) calendar days of the change;

(ii) if the department proposes to suspend a laboratory’s certificate of approval, the laboratory shall be given written notice of the proposed suspension, stating the reason or reasons for such proposed suspension. Such notice shall be sent by certified mail and shall be a final determination to be effective ten (10) days from the date of the notice, unless reconsideration is requested. A laboratory may request reconsideration of the proposed suspension by submitting a written request for reconsideration to the department within ten (10) days of the date of the notice of proposed suspension. Submission of a request for reconsideration within ten (10) days shall stay any action to suspend department approval, pending the department’s decision regarding such request for reconsideration. The written request for reconsideration shall be signed by the owner(s) and the technical director(s) designated responsible for the affected category(ies), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the suspension or disclose that the suspension was based upon a mistake of fact. The department shall review its proposal to suspend approval and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed suspension, allow retention of the certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(5) An environmental laboratory whose certificate of approval is suspended pursuant to paragraphs (3) or (4) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements. A laboratory so suspended shall discontinue analysis of samples for the analytes and/or categories affected by the suspension, as of the date of the suspension.

(6) The department shall change a laboratory’s certification status from suspended to approved upon receipt of sufficient documentation to permit the department to determine that the conditions meriting suspension no longer exist, and the laboratory meets the criteria for a certificate of approval in section 55-2.4 of this Subpart.

(7) Notwithstanding any of the provisions of this subdivision, the Commissioner of Health may suspend a laboratory's certificate of approval pursuant to the summary action provisions of Public Health Law section 16.

(d)(1) The department may revoke an environmental laboratory’s certificate of approval in affected analytes and/or categories for reasons including:

(i) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(ii) a pattern of deficiencies on on-site assessment, or other demonstration that the laboratory lacks an effective 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;

(iii) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe;

(iv) failure to correct the deficiencies meriting suspension within six (6) months of the effective date of the suspension; or

(v) for an environmental laboratory suspended pursuant to section 55-2.6(c)(3) of this Subpart, unsatisfactory performance in the next PT event results in three (3) consecutive failed PT events.

(2) An environmental laboratory whose certificate of approval is revoked pursuant to paragraph (1) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements, and may reapply for approval once the deficiencies meriting revocation have been corrected.

(3) The department may revoke an environmental laboratory’s certificate of approval, in total, for reasons including:

(i) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(ii) failure to participate in a PT program acceptable to the department;

(iii) falsification of any report on or related to a laboratory analysis, including, but not limited to, submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(iv) misrepresentation of any material fact pertinent to obtaining or maintaining approval;

(v) denial of laboratory entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart for on-site assessment during normal business hours;

(vi) 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(s) or technical director(s), individually or jointly, or against any laboratory owned or directed by such individuals;

(vii) 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;

(viii) failure to remit the annual approval fee, or, for partial fee payments, failure to remit such payments within the timeframes established by the department;

(ix) aiding and/or abetting in the violation of any of the provisions of this Subpart; and/or

(x) a finding by a municipality that the environmental laboratory has violated a local ordinance related either to collection and analysis of samples or specimens, or to reporting of results for examination of such samples or specimens.

(4) If an environmental laboratory’s certificate of approval has been revoked pursuant to paragraph (3) above and the department finds that the violation was willful, or due to recklessness or gross negligence, no application shall be accepted, for a period of time to be determined by the Commissioner of Health or his or her designee, from any person who was an owner or technical director of such laboratory on the date of notification of proposed approval revocation.

(e) No environmental laboratory’s certificate of approval may be revoked without a hearing or an opportunity for a hearing. The environmental laboratory shall be given written notice of proposed revocation, stating the reason(s) for the department’s proposed action. Such notice shall be sent by certified mail and shall be a final determination, to be effective thirty (30) calendar days from the date of the notice, unless a hearing is requested by the laboratory. The environmental laboratory may request a hearing by submitting a written request for a hearing, signed by both the owner(s) and the technical director(s) designated responsible for the affected category(ies), within ten (10) calendar days of the date of the department’s notice of proposed revocation. Approval shall be automatically suspended while any hearing requested is pending, provided the hearing is scheduled to begin within ninety (90) calendar days of the request for such hearing.

(f) An environmental laboratory whose certificate of approval has been revoked shall submit a new application for approval and shall meet all criteria for approval provided in section 55-2.4 of this Subpart to be issued a certificate of approval. The department may conduct an on-site assessment of the environmental laboratory before acting on such application.