New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 55 - APPROVAL OF LABORATORIES › Subpart 55-2 - APPROVAL OF LABORATORIES PERFORMING ENVIRONMENTAL ANALYSIS › Section 55-2.6 - Denial, suspension and revocation of department approval

Current through Register Vol. 46, No. 28, July 10, 2024
(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) 
					 of this Subpart, 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 relating 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 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 with
					 the specified timeframe; and/or
(11) denial of entry to representatives of
					 the department or a State program recognized by the department pursuant to
					 section
					 55-2.9 
					 of this Subpart, for on-site assessment during normal business hours.