Kan. Admin. Regs. § 28-15-35 - Conditions of accreditation

Current through Register Vol. 40, No. 39, September 30, 2021

(a) Definitions. For the purposes of this article, the following definitions shall be used:
(1) "Accreditation" means the issuance of a document by the secretary attesting to the fact that a laboratory meets the minimum requirements specified in K.A.R. 28-15-35, 28-15-36, 28-15-36a, and 28-15-37. For the purposes of this article, the terms "accreditation" and "certification" are equivalent.
(A) "Primary accreditation" means the accreditation granted to a laboratory based on a review of the laboratory by the department for conformance with accreditation requirements.
(B) "Secondary accreditation" means the accreditation granted by reciprocity, which is based on primary accreditation granted by another state.
(2) "Accredited," when used to describe a laboratory, means that the laboratory meets all of the requirements for accreditation as specified in K.A.R. 28-15-35, 28-15-36, 28-15-36a, and 28-15-37.
(3) "Accrediting authority" means a territorial, state, federal, or international governmental agency that has responsibility and accountability for environmental laboratory accreditation and that grants accreditation.
(4) "Analyst" means a person who performs the analytical methods and associated techniques and who is responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality.
(5) "Clean water act" and "CWA" mean U.S. public law 92-500, as amended by public law 92-217, public law 95-576, public law 96-483, and public law 97-117, and 33 U.S.C. 1251 et seq., as in effect on February 4, 1987, which governs water pollution control programs.
(6) "Denial" means the department's refusal to accredit a laboratory after submission of an application.
(7) "Department" means the Kansas department of health and environment.
(8) "EPA" means the U.S. environmental protection agency.
(9)
(A) "Field of accreditation" means the following:
(i) The matrix;
(ii) the technology or method, or both; and
(iii) the analyte or analyte group, or both.
(B) The matrices shall include the following:
(i) Drinking water;
(ii) nonpotable water, including all aqueous samples that are not public drinking water;
(iii) solid and chemical materials, including soils, sediments, other solids, and nonaqueous liquids; and
(iv) air and emissions, including ambient air and stack emissions.
(10) "Field of proficiency testing" means studies of proficiency testing by the following:
(A) The matrix;
(B) the technology; and
(C) the analyte or analyte group, or both.
(11) "Field laboratory" means any Kansas environmental laboratory performing compliance analyses limited to one or more of the following fields of accreditation:
(A) Chlorine;
(B) dissolved oxygen;
(C) hydrogen ion (pH);
(D) sulfite;
(E) temperature; or
(F) turbidity.
(12) "Interim accreditation" means accreditation issued for either of the following:
(A) An additional field of accreditation utilizing a technology previously inspected by the laboratory accreditation officer and for which the laboratory meets all other accreditation requirements including acceptable proficiency testing studies, if available; or
(B) a field laboratory before inspection.
(13) "Laboratory" means a legally identifiable facility performing environmental analyses in a controlled and scientific manner.
(14) "Laboratory accreditation officer" means any person determined by the secretary to have adequate credentials to evaluate laboratories supplemented by successful completion of the EPA drinking water laboratory accreditation officers' training course, nationally approved assessor training courses, and refresher training courses.
(15) "Laboratory technical director" means a person whose functions are to direct technical personnel and evaluate the quality of test procedures performed in the laboratory.
(16) "Proficiency testing sample" and "PT" mean a sample the composition of which is unknown to the analyst. The PT samples are used to test whether or not the laboratory can produce analytical results within specific performance limits.
(17) "Reciprocity" means the secretary's recognition of the validity of the accreditation granted by another accrediting authority, in order to issue Kansas accreditation based upon the evaluation conducted by that accrediting authority.
(18) "Resource conservation and recovery act" and "RCRA" mean 42 U.S.C. 6921, as amended by the solid waste disposal act of 1980, public law 94-482, as in effect on October 21, 1980, and as amended by the hazardous and solid waste act of 1984, public law 96-616, as in effect on November 8, 1984, which governs solid and hazardous waste programs.
(19) "Revocation" means the withdrawal of a laboratory's accreditation.
(20) "Safe drinking water act" and "SDWA" mean 42 U.S.C. §300f et seq., as in effect on August 8, 2005, formerly public law 104-182 et seq., which governs drinking water programs.
(21) "Secretary" means the secretary of the Kansas department of health and environment.
(22) "Supplemental accreditation" means accreditation based upon state-of-the-art technology for which the EPA has not given method approval and for which monitoring is required by the department.
(23) "Suspension" means the temporary removal of a laboratory's accreditation for a period of time that shall not exceed six months.
(24) "Technology" means a specific arrangement of analytical instruments, detection systems, or preparation techniques, or any combination of these.
(b) Application for accreditation. The requirements for applying for and maintaining accreditation shall be as follows:
(1) A complete application shall be submitted on forms provided by the department.
(2) Each laboratory, to maintain uninterrupted accreditation, shall file an application for renewal at least 60 calendar days before the current accreditation expires.
(3) Each applicant shall be subject to the payment of fees as specified in K.A.R. 28-15-37.
(4) When applications are submitted by accredited laboratories requesting accreditation for an additional field of accreditation, the expiration date for the additional accreditation shall be the same date indicated on the certificate currently in effect for that laboratory. Additional fees shall be assessed for each additional method for each scope of accreditation as specified in K.A.R. 28-15-37.
(c) Scope of accreditation. Laboratories may be accredited for any of the following:
(1) Drinking water (SDWA);
(2) wastewater (CWA);
(3) solid and hazardous waste (RCRA); or
(4) field laboratory. Accreditation of field laboratories shall be limited to the fields of accreditation specified in paragraph (a)(11) of this regulation.
(d) On-site assessment.
(1) Each on-site assessment of a laboratory shall be conducted by a laboratory accreditation officer at least once every two years. Each on-site assessment shall be conducted to determine whether the laboratory meets the minimum requirements for accreditation as specified in K.A.R. 28-15-35 and 28-15-36.
(2) Each on-site assessment of a field laboratory shall be conducted by a laboratory accreditation officer at least once every three years. On-site assessments shall be conducted to determine whether the laboratory meets the minimum requirements for accreditation as specified in K.A.R. 28-15-35 and 28-15-36a.
(3) Additional on-site assessments may be performed to resolve problems indicated by deficiencies from proficiency testing, deficiencies from prior on-site assessments, or changes that an accredited laboratory makes in location, personnel, or methodology. Other on-site assessments may be conducted to resolve complaints.
(4) If deficiencies are identified during the on-site assessment, a deficiency report shall be submitted to the laboratory by the department. The laboratory shall respond to the deficiency report with corrective action within 30 days of receiving the deficiency report. If corrective action is considered not acceptable by the laboratory accreditation officer, the laboratory shall have an additional 30 days after notification of nonacceptance to submit a revised plan for corrective action. Failure to comply with this requirement shall result in denial, suspension or revocation of accreditation as established in paragraphs (g)(1), (g)(3), and (g)(5) of this regulation.
(e) Proficiency testing. For initial and continuing accreditation, each laboratory, excluding field laboratories, shall participate in proficiency testing studies obtained from a nationally accredited proficiency test provider. Each laboratory shall demonstrate the successful performance of each test method for each proficiency testing field of accreditation for which the laboratory seeks or maintains accreditation. Laboratories shall be permitted to report multiple results for the same field of proficiency testing from one PT sample by using more than one method and type of technology.
(1) For initial accreditation, the laboratory shall meet the following requirements:
(A) Successfully complete two proficiency testing studies out of the three most recent rounds attempted; and
(B) schedule proficiency testing studies at least 15 days after the closing date of the previous study analyzed by the laboratory. The most recent three rounds attempted shall have occurred within 18 months of the date the laboratory submitted an application for accreditation. A result shall be considered unacceptable if the laboratory reports values for a field of proficiency testing outside of the acceptance limits.
(2)
(A) For continuing accreditation, the laboratory shall meet the following requirements:
(i) Participate in a proficiency testing study twice per year. The completion dates of successive PT studies shall be approximately six months apart; and
(ii) maintain a performance history of at least two acceptable proficiency testing studies out of the three most recent studies. A result shall be considered unacceptable when either the laboratory reports values outside of the acceptance limits or the laboratory fails to participate in a study.
(B) Failure to maintain the acceptable performance history as specified in paragraph (e)(2)(A)(ii) shall result in suspension of the method related to the affected field of accreditation.
(C) A laboratory may elect to analyze a remedial proficiency testing sample after obtaining unacceptable results. The remedial sample shall be scheduled at least 15 days after the closing date of the previous study analyzed by the laboratory. The remedial sample shall be considered part of the laboratory's corrective action. The result shall count as part of the historical two-out-of-three performance criteria. If the result from the remedial sample is unacceptable, the laboratory shall be subject to suspension of the affected field of accreditation.
(3) After loss of accreditation of a field of accreditation due to nonacceptable performance, the laboratory shall complete two acceptable proficiency testing studies out of the three most recent studies attempted for the failed field of accreditation before accreditation may be reinstated. Each study shall be scheduled at least 15 days after the closing date of the previous study analyzed by the laboratory.
(4) Proficiency test providers shall report the laboratory results for proficiency test samples in the format listed in "proficiency testing electronic data formats," published April 2003 by the department and hereby adopted by reference.
(5) During participation in a proficiency testing study and before the release of the results of the study, all of the following requirements shall be met:
(A) The laboratory's management and all analysts shall ensure that all PT samples are handled, managed, analyzed, and reported utilizing the staff, methods, procedures, equipment, quality controls, facilities, and frequency of analysis that are used for routine analysis of real environmental samples.
(B) The laboratory shall not send proficiency testing samples to another laboratory for any analysis for which the laboratory seeks accreditation.
(C) The laboratory shall not knowingly accept proficiency testing samples from another laboratory for any analysis for which the sender is seeking accreditation.
(D) The laboratory personnel shall not exchange or offer information about proficiency testing sample results with personnel from another laboratory.
(E) The laboratory personnel shall not attempt to obtain the true values of any proficiency testing samples from the provider.
(f) Notification of accreditation. A certificate shall be issued by the secretary to each laboratory satisfactorily meeting all requirements of K.A.R. 28-15-35, 28-15-36, 28-15-36a, and 28-15-37. The fields of accreditation for which the laboratory is accredited shall be noted. An accreditation number shall be assigned to each accredited laboratory and shall be included on the certificate. The certificate shall be issued for a 12-month period.
(g) Denial, suspension, or revocation of accreditation.
(1) Denial of accreditation. Laboratory accreditation shall be denied in part or in total for any of the following reasons:
(A) Failure to submit a complete application;
(B) failure to meet the requirements specified in this regulation and in K.A.R. 28-15-36 and K.A.R. 28-15-36a;
(C) failure to successfully analyze and report proficiency testing samples as required in subsection (e) of this regulation;
(D) failure to demonstrate to the laboratory accreditation officer that the laboratory meets the required standards for accreditation, based upon an on-site assessment;
(E) failure to respond to the deficiency report with acceptable corrective action after an on-site assessment within the time period established in paragraph (d)(4) of this regulation;
(F) failure to implement corrective action;
(G) misrepresentation or omission of material facts;
(H) denial of entry during normal business hours for an on-site assessment;
(I) failure to pay the required fees as established in K.A.R. 28-15-37;
(J) failure to ensure that essential laboratory personnel are available for participation, as needed, for the satisfactory completion of an on-site assessment;
(K) any prior sustained charges of administrative violations of state or federal laws and regulations related to the provision of environmental laboratory services or reimbursement for these services, against the owner or owners or laboratory technical director or directors, individually or jointly, or against any laboratory owned or directed by these individuals; or
(L) conviction for a crime that is related to environmental laboratory services and involves theft or fraud.
(2) Accreditation after denial.
(A) Accreditation shall not be granted until a laboratory has demonstrated to the laboratory accreditation officer that the deficiencies that caused the denial have been corrected.
(B) If the laboratory is not successful in correcting the deficiencies that caused the denial, the laboratory shall wait six months before submitting a new application.
(C) After denial of accreditation in part, the laboratory shall reapply for accreditation of the affected fields of accreditation. After denial of accreditation in total, the laboratory shall submit a complete application to the department.
(3) Suspension of accreditation. Any accredited laboratory's accreditation may be suspended in part or in total for any of the following reasons:
(A) Failure to notify the laboratory accreditation officer in writing within 30 days of changes in ownership, laboratory personnel, laboratory location, or methods that involve a change in technology or instrumentation;
(B) failure to successfully analyze and report proficiency testing samples as required in subsection (e);
(C) failure to respond to the deficiency report with acceptable corrective action after an on-site assessment;
(D) failure to respond to the deficiency report after an on-site assessment within the time period established in paragraph (d)(4);
(E) failure to implement corrective action after an onsite assessment; or
(F) failure to maintain compliance with this regulation and with K.A.R. 28-15-36, 28-15-36a, and 28-15-37.
(4) Accreditation after suspension.
(A) Accreditation after suspension shall not be granted until a laboratory has demonstrated to the laboratory accreditation officer that the deficiencies that caused suspension have been corrected.
(B) After suspension of accreditation in part, the laboratory shall reapply for accreditation of the affected fields of accreditation. After suspension of accreditation in total, the laboratory shall submit a complete application to the department.
(C) If the laboratory does not correct the deficiencies that caused the suspension within six months, the laboratory accreditation shall be revoked in part or in total.
(5) Revocation of accreditation.
(A) An accreditation may be revoked in part or in total if it is determined that there has been any of the following:
(i) Failure to maintain compliance with K.A.R. 28-15-35, 28-15-36, 28-15-36a, and 28-15-37;
(ii) reporting, as official compliance data, any field of accreditation or analytical result for which accreditation has not been obtained;
(iii) failure to respond to the deficiency report with acceptable corrective action after an on-site assessment;
(iv) failure to respond to the deficiency report after an on-site assessment within the time period established in paragraph (d)(4); or
(v) failure to implement corrective action after an onsite assessment.
(B) An accreditation may be revoked in total if it is determined that there has been any of the following:
(i) Misrepresentation or omission of material facts;
(ii) failure to participate in proficiency testing studies as required in subsection (e);
(iii) denying entry to a laboratory accreditation officer during the laboratory's working hours;
(iv) failure to ensure that essential laboratory personnel are available for participation, as needed, for the satisfactory completion of an on-site assessment;
(v) any prior sustained charges of administrative violations of state or federal laws and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or owners or laboratory technical director or directors, individually or jointly, or against any laboratory owned or directed by these individuals; or
(vi) conviction for a crime that is related to environmental laboratory services and involves theft or fraud.
(6) Accreditation after revocation.
(A) After revocation, accreditation shall not be granted until a laboratory has corrected the reason for revocation and has met all the requirements of the revocation order.
(B) After revocation of accreditation in part, the laboratory shall reapply for accreditation of the affected fields of accreditation. After revocation of accreditation in total, the laboratory shall submit a complete application to the department.
(h) Analytical results obtained after an accreditation has been suspended or revoked shall not be submitted to the department as official compliance data.
(i) Reciprocity.
(1) Establishment of reciprocity for the accreditation of laboratories located outside of the state of Kansas. Laboratories located outside of the state of Kansas that perform laboratory services as specified in K.S.A. 65-163 through K.S.A. 65-171t and amendments thereto, this regulation, and K.A.R. 28-16-28b, K.A.R. 28-16-63, and K.A.R. 28-31-4 may be accredited by the department, if the laboratory is accredited by a national environmental laboratory accrediting authority that the secretary recognizes as having standards equivalent to those standards established in this regulation and K.A.R. 28-15-36.
(2) Each out-of-state laboratory shall submit an application to the department with a copy of the current certificate issued by the primary accrediting authority or authorities, and the accreditation fees specified in K.A.R. 28-15-37.
(3) Laboratories located outside of Kansas shall not be approved as field laboratories.
(4) The laboratory shall be accredited only for the requested fields of accreditation for which it holds accreditation from its primary accrediting authority or authorities. The laboratory shall be accredited by the department for only fields of accreditation included in the Kansas scope of accreditation.
(5) In lieu of reciprocity, any out-of-state laboratory may apply for primary accreditation from the department if all of the following criteria are met:
(A) The on-site assessment of the laboratory is conducted by a third-party assessor contracted by the department.
(B) All fees and expenses for the on-site assessment of the laboratory are paid by the laboratory directly to the third-party assessor.
(C) The laboratory meets all other requirements for accreditation as specified in this regulation and in K.A.R. 28-15-36 and 28-15-37.
(j) Laboratory withdrawal of accreditation. Any laboratory may withdraw its application for accreditation at any time during the accreditation process. Any laboratory may withdraw from accreditation at any time during the accreditation period. In both cases, each laboratory shall notify the department in writing. The fees submitted to the department up to the time of the notification shall not be refunded, as specified in K.A.R. 28-15-37.
(k) The change in legal status, ownership, or location of an accredited laboratory.
(1) Each accredited laboratory shall notify the department, in writing, of any change in legal status, ownership or location, or any combination of these, within 30 calendar days of the change.
(2) Accreditation shall be transferred if the change in legal status or ownership of the accredited laboratory does not affect the laboratory's staff, equipment, and organization.
(3) Accreditation shall not be transferred if the change in legal status or ownership of the accredited laboratory affects the laboratory's staff, equipment, and organization. The laboratory shall be required to apply for accreditation as specified in subsection (b).
(4) Any change in the legal status, ownership, or location, or any combination of these, may require an on-site assessment of the laboratory by a laboratory accreditation officer.
(5) If a change in ownership occurs, all records and analyses that have been performed and that pertain to accreditation shall be retained for a minimum of five years and shall be subject to inspection by the department during this period without prior notification to the laboratory.

Notes

Kan. Admin. Regs. § 28-15-35
Authorized by K.S.A. 65-1,109a; implementing K.S.A. 65-171l and 65-1,109a; effective, E-79-14, June 23, 1978; effective May 1, 1979; amended May 1, 1983; amended May 1, 1986; amended May 1, 1988; amended Jan. 24, 1994; amended May 25, 2001; amended March 26, 2004; amended June 1, 2007.

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