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Article 3. Environmental Laboratories of California Health And Safety Code >> Division 101. >> Part 1. >> Chapter 4. >> Article 3.
(a) This article shall be known, and may be cited, as the
Environmental Laboratory Accreditation Act.
(b) Laboratories that perform analyses on any combination of environmental samples, or raw or processed agricultural products for regulatory purposes shall obtain a certificate of accreditation pursuant to this article.
(c) Unless the express language or context requires otherwise, the definitions in this article shall govern the construction of the article.
(1) "Accreditation" means the recognition of a laboratory by the department to conduct analyses of environmental samples for regulatory purposes.
(2) "Assessor body" means the organization that actually executes the accreditation process, including receiving and reviewing applications, documents, PT sample results, and onsite assessments.
(3) "Certificate" means a document issued by the department to a laboratory that has received accreditation pursuant to this article.
(4) "Department" means the State Department of Health Services.
(5) "Environmental samples" means potable and nonpotable surface waters or groundwaters, soils and sediments, hazardous wastes, biological materials, or any other sample designated for regulatory purposes.
(6) "NELAC" means the National Environmental Laboratory Accreditation Conference.
(7) "NELAC standards" refers to the requirements found in EPA publication number 600/R-98/151, November 1998, and any subsequent amendments that are adopted by EPA or the national program.
(8) "NELAP" means the National Environmental Laboratory Accreditation Program established by NELAC.
(9) "NELAP accreditation" means the accreditation of a laboratory that has met the requirements of the NELAC standards, and the requirements of this article.
(10) "NELAP accredited laboratory" means a laboratory that has met the standards of NELAC and has been accredited by a primary or secondary NELAP-recognized accrediting authority.
(11) "NELAP-recognized accrediting authority" means a state agency that is authorized by NELAP to accredit laboratories.
(12) "NELAP-recognized primary accrediting authority" means a state agency that is responsible for the accreditation of environmental laboratories within that state or that performs the primary accreditation of a lab from a non-NELAP state or where the laboratory's home state does not offer accreditation in a given field of accreditation.
(13) "NELAP-recognized secondary accrediting authority" means a state agency that is authorized by NELAP to accredit environmental laboratories within that state that have been accredited by a NELAP-approved accrediting authority in another state.
(14) "Proficiency testing (PT)" is a means of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.
(15) "PT sample" means a sample used for proficiency testing.
(16) "Regulatory purposes" means a statutory or regulatory requirement of a state board, office, or department, or of a division or program that requires a laboratory certified under this article or of any other state or federal agency that requires a laboratory to be accredited.
(17) "Revocation" means the permanent loss of a certificate of accreditation, including all units and fields of accreditation for state accreditation and all fields of accreditation for NELAP accreditation.
(18) "State accreditation" means accreditation of a laboratory, that has met the requirements of this article and regulations adopted by the department pursuant to this article.
(19) "Suspension" means the temporary loss of a certificate of accreditation or a unit or field of accreditation.
(b) Laboratories that perform analyses on any combination of environmental samples, or raw or processed agricultural products for regulatory purposes shall obtain a certificate of accreditation pursuant to this article.
(c) Unless the express language or context requires otherwise, the definitions in this article shall govern the construction of the article.
(1) "Accreditation" means the recognition of a laboratory by the department to conduct analyses of environmental samples for regulatory purposes.
(2) "Assessor body" means the organization that actually executes the accreditation process, including receiving and reviewing applications, documents, PT sample results, and onsite assessments.
(3) "Certificate" means a document issued by the department to a laboratory that has received accreditation pursuant to this article.
(4) "Department" means the State Department of Health Services.
(5) "Environmental samples" means potable and nonpotable surface waters or groundwaters, soils and sediments, hazardous wastes, biological materials, or any other sample designated for regulatory purposes.
(6) "NELAC" means the National Environmental Laboratory Accreditation Conference.
(7) "NELAC standards" refers to the requirements found in EPA publication number 600/R-98/151, November 1998, and any subsequent amendments that are adopted by EPA or the national program.
(8) "NELAP" means the National Environmental Laboratory Accreditation Program established by NELAC.
(9) "NELAP accreditation" means the accreditation of a laboratory that has met the requirements of the NELAC standards, and the requirements of this article.
(10) "NELAP accredited laboratory" means a laboratory that has met the standards of NELAC and has been accredited by a primary or secondary NELAP-recognized accrediting authority.
(11) "NELAP-recognized accrediting authority" means a state agency that is authorized by NELAP to accredit laboratories.
(12) "NELAP-recognized primary accrediting authority" means a state agency that is responsible for the accreditation of environmental laboratories within that state or that performs the primary accreditation of a lab from a non-NELAP state or where the laboratory's home state does not offer accreditation in a given field of accreditation.
(13) "NELAP-recognized secondary accrediting authority" means a state agency that is authorized by NELAP to accredit environmental laboratories within that state that have been accredited by a NELAP-approved accrediting authority in another state.
(14) "Proficiency testing (PT)" is a means of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.
(15) "PT sample" means a sample used for proficiency testing.
(16) "Regulatory purposes" means a statutory or regulatory requirement of a state board, office, or department, or of a division or program that requires a laboratory certified under this article or of any other state or federal agency that requires a laboratory to be accredited.
(17) "Revocation" means the permanent loss of a certificate of accreditation, including all units and fields of accreditation for state accreditation and all fields of accreditation for NELAP accreditation.
(18) "State accreditation" means accreditation of a laboratory, that has met the requirements of this article and regulations adopted by the department pursuant to this article.
(19) "Suspension" means the temporary loss of a certificate of accreditation or a unit or field of accreditation.
A laboratory accredited by the department shall report, in
a timely fashion and in accordance with the request for analysis, the
full and complete results of all detected contaminants and
pollutants to the person or entity that submitted the material for
testing. The department may adopt regulations to establish reporting
requirements for this section.
The department may do all of the following related to
accrediting environmental laboratories in the state:
(a) Offer both state accreditation and NELAP accreditation, which shall be considered equivalent for regulatory activities covered by this article.
(b) Adopt regulations to establish the accreditation procedures for both types of accreditation.
(c) Retain exclusive authority to grant NELAP accreditation.
(d) Accept certificates of accreditation from laboratories that have been accredited by other NELAP-recognized accrediting authorities.
(e) Adopt regulations to establish procedures for recognizing the accreditation of laboratories located outside California for activities regulated under this article.
(f) (1) Adopt regulations for the collection of laboratory accreditation fees.
(2) Fees collected under this section shall be adjusted annually as provided in Section 100425. The adjustment shall be rounded to the nearest whole dollar.
(3) Fees shall be set for the two types of accreditation provided for in subdivision (a).
(4) Programs operated under this article shall be fully fee-supported.
(a) Offer both state accreditation and NELAP accreditation, which shall be considered equivalent for regulatory activities covered by this article.
(b) Adopt regulations to establish the accreditation procedures for both types of accreditation.
(c) Retain exclusive authority to grant NELAP accreditation.
(d) Accept certificates of accreditation from laboratories that have been accredited by other NELAP-recognized accrediting authorities.
(e) Adopt regulations to establish procedures for recognizing the accreditation of laboratories located outside California for activities regulated under this article.
(f) (1) Adopt regulations for the collection of laboratory accreditation fees.
(2) Fees collected under this section shall be adjusted annually as provided in Section 100425. The adjustment shall be rounded to the nearest whole dollar.
(3) Fees shall be set for the two types of accreditation provided for in subdivision (a).
(4) Programs operated under this article shall be fully fee-supported.
The department may do all of the following:
(a) Adopt regulations establishing requirements for both types of accreditation. The regulations shall include, but not be limited to, all of the following:
(1) Laboratory personnel.
(2) Quality assurance procedures.
(3) Laboratory equipment.
(4) Facilities.
(5) Standard operating procedures.
(6) Proficiency testing.
(7) Onsite assessments.
(8) Recordkeeping.
(9) Units and fields of accreditation.
(b) Adopt regulations establishing conditions under which the department may issue, deny, renew, or suspend a certificate of accreditation for individual units or fields. Suspension and denial of units or fields of accreditation shall be based on a laboratory's failure to comply with this article and regulations adopted thereunder.
(a) Adopt regulations establishing requirements for both types of accreditation. The regulations shall include, but not be limited to, all of the following:
(1) Laboratory personnel.
(2) Quality assurance procedures.
(3) Laboratory equipment.
(4) Facilities.
(5) Standard operating procedures.
(6) Proficiency testing.
(7) Onsite assessments.
(8) Recordkeeping.
(9) Units and fields of accreditation.
(b) Adopt regulations establishing conditions under which the department may issue, deny, renew, or suspend a certificate of accreditation for individual units or fields. Suspension and denial of units or fields of accreditation shall be based on a laboratory's failure to comply with this article and regulations adopted thereunder.
All regulations adopted by the department pursuant to this
article, as they read immediately preceding January 1, 2006, shall
remain in full force and effect until repealed or amended by the
department in accordance with the rulemaking provisions of the
Administrative Procedure Act, Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code.
The department may contract with approved third-party
laboratory assessor bodies in accordance with the criteria developed
by the NELAC or other federal agencies.
Any laboratory requesting ELAP certification or NELAP
accreditation under this article shall file with the department an
application on forms prescribed by the department containing all of
the following:
(a) The names of the applicant and the laboratory.
(b) The location of the laboratory.
(c) A list of fields of testing for which the laboratory is seeking certification, selected from the activities listed in Section 100860.1 or 100862.
(d) Evidence satisfactory to the department that the applicant has the ability to comply with this article and the regulations adopted under this article.
(e) Any other information required by the department for administration or enforcement of this article or regulations adopted under this article.
(a) The names of the applicant and the laboratory.
(b) The location of the laboratory.
(c) A list of fields of testing for which the laboratory is seeking certification, selected from the activities listed in Section 100860.1 or 100862.
(d) Evidence satisfactory to the department that the applicant has the ability to comply with this article and the regulations adopted under this article.
(e) Any other information required by the department for administration or enforcement of this article or regulations adopted under this article.
(a) Each certificate issued pursuant to this article for
ELAP certification shall be issued to the owner of the laboratory and
shall expire 24 months from the date of issuance. An application for
renewal shall be filed with the department prior to the expiration
date of the certificate. Failure to make timely application for
renewal shall result in expiration of the certificate.
(b) A certificate shall be forfeited by operation of law prior to its expiration date when one of the following occurs:
(1) The owner sells or otherwise transfers the ownership of the laboratory, except that the certificate shall remain in force 90 calendar days if the department receives written assurance and appropriate documentation within 30 calendar days after the change has occurred that one or more of the conditions in subdivision (c) are met. The department shall accept or reject the assurance in writing within 30 calendar days after it has been received.
(2) There is a change in the location of the laboratory (except a mobile laboratory) or structural alteration that may affect adversely the quality of analysis in the fields of testing for which the laboratory has been certified or is seeking certification, without written notification to the department within 30 calendar days.
(3) The certificate holder surrenders the certificate to the department.
(c) Upon change of ownership of a laboratory, the department may extend a certificate to the expiration date of the original certificate upon written assurance by the new owner that the operation of the laboratory will continue so as not to adversely affect the conditions regulated by this article.
(d) The department shall be notified in writing within 30 calendar days whenever there is a change of director or other person in charge of a laboratory certified under this article. The notification shall include documentation of the qualifications of the new director or other person in charge of the laboratory.
(b) A certificate shall be forfeited by operation of law prior to its expiration date when one of the following occurs:
(1) The owner sells or otherwise transfers the ownership of the laboratory, except that the certificate shall remain in force 90 calendar days if the department receives written assurance and appropriate documentation within 30 calendar days after the change has occurred that one or more of the conditions in subdivision (c) are met. The department shall accept or reject the assurance in writing within 30 calendar days after it has been received.
(2) There is a change in the location of the laboratory (except a mobile laboratory) or structural alteration that may affect adversely the quality of analysis in the fields of testing for which the laboratory has been certified or is seeking certification, without written notification to the department within 30 calendar days.
(3) The certificate holder surrenders the certificate to the department.
(c) Upon change of ownership of a laboratory, the department may extend a certificate to the expiration date of the original certificate upon written assurance by the new owner that the operation of the laboratory will continue so as not to adversely affect the conditions regulated by this article.
(d) The department shall be notified in writing within 30 calendar days whenever there is a change of director or other person in charge of a laboratory certified under this article. The notification shall include documentation of the qualifications of the new director or other person in charge of the laboratory.
(a) The period of accreditation for NELAP accredited
laboratories shall be 12 months. An application for renewal shall be
filed with the department prior to the expiration date of the
accreditation. Failure to make timely application for renewal shall
result in expiration of the accreditation.
(b) The accrediting authority shall be notified in writing within 30 calendar days of the sale or other transfer of ownership of a NELAP accredited laboratory.
(c) The accrediting authority shall be notified in writing within 30 calendar days of the change in location of a NELAP accredited laboratory, other than a mobile laboratory.
(d) The accrediting authority shall be notified within 30 calendar days whenever there is a change of laboratory director, or other individual in charge of the laboratory.
(e) NELAP accredited laboratories shall conspicuously display their most recent NELAP accreditation certificate or their accreditation fields of testing, or both, in a permanent place in their laboratory.
(f) NELAP accredited laboratories shall not use their NELAP accreditation document or their accreditation status to imply any endorsement by the accrediting authority.
(b) The accrediting authority shall be notified in writing within 30 calendar days of the sale or other transfer of ownership of a NELAP accredited laboratory.
(c) The accrediting authority shall be notified in writing within 30 calendar days of the change in location of a NELAP accredited laboratory, other than a mobile laboratory.
(d) The accrediting authority shall be notified within 30 calendar days whenever there is a change of laboratory director, or other individual in charge of the laboratory.
(e) NELAP accredited laboratories shall conspicuously display their most recent NELAP accreditation certificate or their accreditation fields of testing, or both, in a permanent place in their laboratory.
(f) NELAP accredited laboratories shall not use their NELAP accreditation document or their accreditation status to imply any endorsement by the accrediting authority.
(a) Upon the filing of an application for ELAP
certification or NELAP accreditation and after a finding by the
department that there is full compliance with this article and
regulations adopted under this article, the department shall issue to
the owner certification or accreditation in the fields of testing
identified in Section 100860.1 or 100862.
(b) The department shall deny or revoke a certificate if it finds any of the following:
(1) The laboratory fails to report acceptable results in the analysis of proficiency testing samples.
(2) The laboratory fails to analyze proficiency testing samples.
(3) The laboratory submits, as its own, proficiency testing sample results generated by another laboratory.
(4) The laboratory fails to pass an onsite assessment.
(5) The laboratory is not in compliance with any other provision of this article or regulations adopted under this article.
(c) Provided that there is compliance with all other provisions of this article, the department may restrict a certificate to the fields of testing of Section 100860 or 100862 or subgroups thereof as defined by regulation for which acceptable proficiency testing results have been produced and the onsite assessment was passed.
(d) Upon the filing of a complete application for certification or accreditation pursuant to subdivision (a) and Section 100870, the department may issue to a laboratory interim certification or accreditation pending the completion of onsite assessment interim certification and accreditation shall be nonrenewable and shall remain in effect until certification and accreditation is either granted under subdivision (a) or denied under subdivision (b), but not later than one year after the date of issuance.
(b) The department shall deny or revoke a certificate if it finds any of the following:
(1) The laboratory fails to report acceptable results in the analysis of proficiency testing samples.
(2) The laboratory fails to analyze proficiency testing samples.
(3) The laboratory submits, as its own, proficiency testing sample results generated by another laboratory.
(4) The laboratory fails to pass an onsite assessment.
(5) The laboratory is not in compliance with any other provision of this article or regulations adopted under this article.
(c) Provided that there is compliance with all other provisions of this article, the department may restrict a certificate to the fields of testing of Section 100860 or 100862 or subgroups thereof as defined by regulation for which acceptable proficiency testing results have been produced and the onsite assessment was passed.
(d) Upon the filing of a complete application for certification or accreditation pursuant to subdivision (a) and Section 100870, the department may issue to a laboratory interim certification or accreditation pending the completion of onsite assessment interim certification and accreditation shall be nonrenewable and shall remain in effect until certification and accreditation is either granted under subdivision (a) or denied under subdivision (b), but not later than one year after the date of issuance.
(a) An application for NELAP accreditation or renewal of
NELAP accreditation shall be denied by the accrediting authority for
any of the following reasons:
(1) Failure to submit all information necessary to determine the laboratory's eligibility for its accreditation or continued compliance with this section or regulations adopted thereunder.
(2) Failure of the laboratory staff to meet NELAC standards for personnel requirements. These qualifications may include education, training, and experience requirements.
(3) Failure to successfully analyze and report proficiency testing samples.
(4) Failure to respond to a deficiency report from the onsite assessment with a corrective action report within 30 calendar days of the receipt of the report.
(5) Failure to implement the corrective actions detailed in the corrective action report within the specified amount of time.
(6) Misrepresentation of any material fact pertinent to receiving or maintaining NELAP accreditation.
(b) The NELAP approved accrediting authority may suspend the accreditation of a NELAP accredited laboratory, in whole or in part, for failure to correct the deficiencies, within a specified amount of time, as identified in the onsite assessment. The laboratory shall retain those areas of accreditation where it continues to meet the requirements of the accrediting authority. A suspended NELAP accredited laboratory shall not be required to reapply for accreditation if the causes for suspension are corrected within six months.
(c) The NELAP approved accrediting authority shall suspend a NELAP accreditation in whole or in part for the following reasons:
(1) Failure to complete proficiency testing studies.
(2) Failure to maintain a history of at least two successful, out of the most recent three, proficiency testing studies for each affected accreditation field of testing, subgroup, or analyte for which the laboratory is accredited.
(3) Failure to successfully analyze and report proficiency testing sample results pursuant to Chapter 2 of the NELAC standards.
(4) Failure to submit an acceptable corrective action report in response to a deficiency report and failure to implement corrective action related to any deficiencies found during laboratory assessments within the required time period, as required by the NELAC standards.
(5) Failure to notify the accrediting authority of any changes in key accreditation criteria, as required by Chapter 4 of the NELAC standards.
(6) Failure to perform all accredited tests in accordance with NELAC standards.
(7) Failure to meet all of the requirements of Chapter 5 of the NELAC standards.
(d) A suspended laboratory shall not be required to reapply for any NELAP accreditation if the causes for suspension are corrected within six months. A suspended laboratory may not continue to analyze samples for the affected fields of testing for which it holds accreditation. A suspended laboratory shall remain suspended without a right to appeal if the suspension is caused by unacceptable proficiency testing sample results.
(e) If a laboratory is unable to correct the reason for suspension, the laboratory's accreditation shall be revoked in whole or in part.
(f) A laboratory's accreditation may not be suspended without the right to due process, as set forth in Chapter 4 of the NELAC standards.
(1) Failure to submit all information necessary to determine the laboratory's eligibility for its accreditation or continued compliance with this section or regulations adopted thereunder.
(2) Failure of the laboratory staff to meet NELAC standards for personnel requirements. These qualifications may include education, training, and experience requirements.
(3) Failure to successfully analyze and report proficiency testing samples.
(4) Failure to respond to a deficiency report from the onsite assessment with a corrective action report within 30 calendar days of the receipt of the report.
(5) Failure to implement the corrective actions detailed in the corrective action report within the specified amount of time.
(6) Misrepresentation of any material fact pertinent to receiving or maintaining NELAP accreditation.
(b) The NELAP approved accrediting authority may suspend the accreditation of a NELAP accredited laboratory, in whole or in part, for failure to correct the deficiencies, within a specified amount of time, as identified in the onsite assessment. The laboratory shall retain those areas of accreditation where it continues to meet the requirements of the accrediting authority. A suspended NELAP accredited laboratory shall not be required to reapply for accreditation if the causes for suspension are corrected within six months.
(c) The NELAP approved accrediting authority shall suspend a NELAP accreditation in whole or in part for the following reasons:
(1) Failure to complete proficiency testing studies.
(2) Failure to maintain a history of at least two successful, out of the most recent three, proficiency testing studies for each affected accreditation field of testing, subgroup, or analyte for which the laboratory is accredited.
(3) Failure to successfully analyze and report proficiency testing sample results pursuant to Chapter 2 of the NELAC standards.
(4) Failure to submit an acceptable corrective action report in response to a deficiency report and failure to implement corrective action related to any deficiencies found during laboratory assessments within the required time period, as required by the NELAC standards.
(5) Failure to notify the accrediting authority of any changes in key accreditation criteria, as required by Chapter 4 of the NELAC standards.
(6) Failure to perform all accredited tests in accordance with NELAC standards.
(7) Failure to meet all of the requirements of Chapter 5 of the NELAC standards.
(d) A suspended laboratory shall not be required to reapply for any NELAP accreditation if the causes for suspension are corrected within six months. A suspended laboratory may not continue to analyze samples for the affected fields of testing for which it holds accreditation. A suspended laboratory shall remain suspended without a right to appeal if the suspension is caused by unacceptable proficiency testing sample results.
(e) If a laboratory is unable to correct the reason for suspension, the laboratory's accreditation shall be revoked in whole or in part.
(f) A laboratory's accreditation may not be suspended without the right to due process, as set forth in Chapter 4 of the NELAC standards.
(a) Notwithstanding any other provision of law, the
department may issue a certificate to the owner of a laboratory in a
field of testing or method adopted by the federal Environmental
Protection Agency pursuant to Part 136 of Title 40 of the Code of
Federal Regulations, as amended September 11, 1992, as published in
the Federal Register (57 FR 41830), or Part 141 of Title 40 of the
Code of Federal Regulations, as amended July 17, 1992, as published
in the Federal Register (57 FR 31776), and as subsequently amended
and published in the Code of Federal Regulations.
(b) As a NELAP approved accreditating authority, the department shall accept performance based measurement system methods, when mandated methods are indicated. A fee, as specified in regulations adopted by the department, may be charged for the review of each performance based measurement system method.
(c) Notwithstanding any other provision of law, the department shall not be required to meet the requirements of Chapter 3.5 (commencing with Section 11340) of the Government Code in order to issue a certificate pursuant to subdivision (a).
(b) As a NELAP approved accreditating authority, the department shall accept performance based measurement system methods, when mandated methods are indicated. A fee, as specified in regulations adopted by the department, may be charged for the review of each performance based measurement system method.
(c) Notwithstanding any other provision of law, the department shall not be required to meet the requirements of Chapter 3.5 (commencing with Section 11340) of the Government Code in order to issue a certificate pursuant to subdivision (a).
Upon the denial of any application for ELAP certification
or NELAP accreditation, or the revocation or suspension of ELAP
certification or NELAP accreditation, the department shall
immediately notify the applicant or organization by certified mail,
return receipt requested, of the action and the reasons for the
action. Within 20 calendar days of receipt, the applicant or
organization may present the department with a written petition for a
hearing. Upon receipt in proper form by the department, the petition
shall be set for hearing. The proceedings shall be conducted in
accordance with Section 100171 and the department has all the powers
granted in that section.
(a) At the time of application and annually thereafter,
from the date of the issuance of the certificate, a laboratory shall
pay an ELAP certification fee. This fee shall consist of a base or
administrative fee and a fee for each of the ELAP fields of testing
listed below for which the laboratory has requested ELAP
certification. These fees shall be nonrefundable and adopted in
regulations, and shall be sufficient to allow the ELAP program to be
fully fee-supported. The fields of testing for ELAP certification and
their code numbers are the following:
(E101) Microbiology of drinking water.
(E102) Inorganic chemistry of drinking water.
(E103) Toxic chemical elements of drinking water.
(E104) Volatile organic chemistry of drinking water.
(E105) Semi-volatile organic chemistry of drinking water.
(E106) Radiochemistry of drinking water.
(E107) Microbiology of wastewater.
(E108) Inorganic chemistry of wastewater.
(E109) Toxic chemical elements of wastewater.
(E110) Volatile organic chemistry of wastewater.
(E111) Semi-volatile organic chemistry of wastewater.
(E112) Radiochemistry of wastewater.
(E113) Whole effluent toxicity of wastewater.
(E114) Inorganic chemistry and toxic chemical elements of hazardous waste.
(E115) Extraction test of hazardous waste.
(E116) Volatile organic chemistry of hazardous waste.
(E117) Semi-volatile organic chemistry of hazardous waste.
(E118) Radiochemistry of hazardous waste.
(E119) Toxicity bioassay of hazardous waste.
(E120) Physical properties of hazardous waste.
(E121) Bulk asbestos analysis of hazardous waste.
(E122) Microbiology of food.
(E123) Inorganic chemistry and toxic chemical elements of pesticide residues in food.
(E124) Organic chemistry of pesticide residues in food (measurements by MS techniques).
(E125) Organic chemistry of pesticide residues in food (excluding measurements by MS techniques).
(E126) Microbiology of recreational water.
(E127) Air quality monitoring.
(E128) Shellfish sanitation.
(b) In addition to the payment of ELAP certification fees, laboratories located outside the State of California shall reimburse the department for travel and per diem necessary to perform onsite inspections.
(c) If reciprocity with another jurisdiction is established by regulation as described in Section 100830, the regulations may provide for the waiver of certification fees for program activities considered equivalent.
(d) Fees collected under this section shall be adjusted annually as specified in Section 100425. The adjustment shall be rounded to the nearest whole dollar. It is the intent of the Legislature that the programs operated under this article be fully fee-supported.
(e) State and local government-owned laboratories in California established under Section 101150 or performing work only in a reference capacity as a reference laboratory are exempt from the payment of the fee prescribed under subdivision (a).
(f) In addition to the payment of certification fees, laboratories certified or applying for certification in fields of testing for pesticide residues in food shall pay a fee directly to the designated proficiency testing provider for the cost of each proficiency testing sample set.
(g) In addition to the payment of certification fees, laboratories certified or applying for certification shall pay directly to the designated proficiency testing provider the cost of the proficiency testing study.
(h) For the purpose of this section, a reference laboratory is a laboratory owned and operated by a governmental regulatory agency for the principal purpose of analyzing samples referred by other laboratories for confirmatory analysis. Reference laboratories carry out quality assurance functions for other laboratories and may carry out unusual, highly specialized, and difficult analyses not generally available through commercial laboratories, and a limited number of routine analyses, for regulatory purposes only, and without assessing per-sample fees for the services.
(i) This section shall become operative January 1, 2002.
(E101) Microbiology of drinking water.
(E102) Inorganic chemistry of drinking water.
(E103) Toxic chemical elements of drinking water.
(E104) Volatile organic chemistry of drinking water.
(E105) Semi-volatile organic chemistry of drinking water.
(E106) Radiochemistry of drinking water.
(E107) Microbiology of wastewater.
(E108) Inorganic chemistry of wastewater.
(E109) Toxic chemical elements of wastewater.
(E110) Volatile organic chemistry of wastewater.
(E111) Semi-volatile organic chemistry of wastewater.
(E112) Radiochemistry of wastewater.
(E113) Whole effluent toxicity of wastewater.
(E114) Inorganic chemistry and toxic chemical elements of hazardous waste.
(E115) Extraction test of hazardous waste.
(E116) Volatile organic chemistry of hazardous waste.
(E117) Semi-volatile organic chemistry of hazardous waste.
(E118) Radiochemistry of hazardous waste.
(E119) Toxicity bioassay of hazardous waste.
(E120) Physical properties of hazardous waste.
(E121) Bulk asbestos analysis of hazardous waste.
(E122) Microbiology of food.
(E123) Inorganic chemistry and toxic chemical elements of pesticide residues in food.
(E124) Organic chemistry of pesticide residues in food (measurements by MS techniques).
(E125) Organic chemistry of pesticide residues in food (excluding measurements by MS techniques).
(E126) Microbiology of recreational water.
(E127) Air quality monitoring.
(E128) Shellfish sanitation.
(b) In addition to the payment of ELAP certification fees, laboratories located outside the State of California shall reimburse the department for travel and per diem necessary to perform onsite inspections.
(c) If reciprocity with another jurisdiction is established by regulation as described in Section 100830, the regulations may provide for the waiver of certification fees for program activities considered equivalent.
(d) Fees collected under this section shall be adjusted annually as specified in Section 100425. The adjustment shall be rounded to the nearest whole dollar. It is the intent of the Legislature that the programs operated under this article be fully fee-supported.
(e) State and local government-owned laboratories in California established under Section 101150 or performing work only in a reference capacity as a reference laboratory are exempt from the payment of the fee prescribed under subdivision (a).
(f) In addition to the payment of certification fees, laboratories certified or applying for certification in fields of testing for pesticide residues in food shall pay a fee directly to the designated proficiency testing provider for the cost of each proficiency testing sample set.
(g) In addition to the payment of certification fees, laboratories certified or applying for certification shall pay directly to the designated proficiency testing provider the cost of the proficiency testing study.
(h) For the purpose of this section, a reference laboratory is a laboratory owned and operated by a governmental regulatory agency for the principal purpose of analyzing samples referred by other laboratories for confirmatory analysis. Reference laboratories carry out quality assurance functions for other laboratories and may carry out unusual, highly specialized, and difficult analyses not generally available through commercial laboratories, and a limited number of routine analyses, for regulatory purposes only, and without assessing per-sample fees for the services.
(i) This section shall become operative January 1, 2002.
(a) At the time of application for NELAP accreditation and
annually thereafter, from the date of the issuance of the
accreditation, a laboratory shall pay a base fee and a fee for each
of the NELAP fields of testing listed below for which a laboratory
has requested NELAP accreditation. The fees shall be nonrefundable
and set in regulations, and shall be sufficient to allow the NELAP
program to be fully fee supported. The fields of testing for NELAP
accreditation and their code numbers are all of the following:
(N101) Microbiology of drinking water.
(N102) Inorganic chemistry of drinking water.
(N103) Toxic chemical elements of drinking water.
(N104) Volatile organic chemistry of drinking water.
(N105) Semi-volatile organic chemistry of drinking water.
(N106) Radiochemistry of drinking water.
(N107) Microbiology of wastewater.
(N108) Inorganic chemistry of wastewater.
(N109) Toxic chemical elements of wastewater.
(N110) Volatile organic chemistry of wastewater.
(N111) Semi-volatile organic chemistry of wastewater.
(N112) Radiochemistry of wastewater.
(N113) Whole effluent toxicity of wastewater.
(N114) Inorganic chemistry and toxic chemical elements of hazardous waste.
(N115) Extraction test of hazardous waste.
(N116) Volatile organic chemistry of hazardous waste.
(N117) Semi-volatile organic chemistry of hazardous waste.
(N118) Radiochemistry of hazardous waste.
(N119) Toxicity bioassay of hazardous waste.
(N120) Physical properties of hazardous waste.
(N121) Bulk asbestos analysis of hazardous waste.
(b) Fees for NELAP accreditation shall be adjusted annually as specified in Section 100425.
(c) In addition to the payment of accreditation fees, laboratories accredited or applying for accreditation shall pay directly to the designated proficiency testing provider the cost of the proficiency testing studies.
(N101) Microbiology of drinking water.
(N102) Inorganic chemistry of drinking water.
(N103) Toxic chemical elements of drinking water.
(N104) Volatile organic chemistry of drinking water.
(N105) Semi-volatile organic chemistry of drinking water.
(N106) Radiochemistry of drinking water.
(N107) Microbiology of wastewater.
(N108) Inorganic chemistry of wastewater.
(N109) Toxic chemical elements of wastewater.
(N110) Volatile organic chemistry of wastewater.
(N111) Semi-volatile organic chemistry of wastewater.
(N112) Radiochemistry of wastewater.
(N113) Whole effluent toxicity of wastewater.
(N114) Inorganic chemistry and toxic chemical elements of hazardous waste.
(N115) Extraction test of hazardous waste.
(N116) Volatile organic chemistry of hazardous waste.
(N117) Semi-volatile organic chemistry of hazardous waste.
(N118) Radiochemistry of hazardous waste.
(N119) Toxicity bioassay of hazardous waste.
(N120) Physical properties of hazardous waste.
(N121) Bulk asbestos analysis of hazardous waste.
(b) Fees for NELAP accreditation shall be adjusted annually as specified in Section 100425.
(c) In addition to the payment of accreditation fees, laboratories accredited or applying for accreditation shall pay directly to the designated proficiency testing provider the cost of the proficiency testing studies.
The department shall appoint a multidisciplinary committee
to assist, advise, and make recommendations regarding technical,
scientific, and administrative matters concerning the accreditation
or certification of environmental laboratories. Appointments to the
committee shall be made from lists of nominees solicited by the
department, and shall provide adequate representation of interested
parties and environmental laboratories subject to this chapter.
Subcommittees of the committee may be appointed consisting of
committee members and other persons having particular knowledge of a
subject area, for the purpose of assisting the department on special
problems and making recommendations to the committee for
consideration in the establishment of rules and regulations. The
department shall determine the terms of office of appointees to the
committee and any subcommittee. Members of the committee and of any
subcommittee shall serve without compensation and shall pay their own
expenses incurred as a result of attending meetings or engaging in
any other activity pursuant to this section.
(a) In order to carry out the purpose of this article, any
duly authorized representative of the department may do the
following:
(1) Enter and inspect a laboratory that is ELAP certified or NELAP accredited pursuant to this article or that has applied for ELAP certification or NELAP accreditation.
(2) Inspect and photograph any portion of the laboratory, equipment, any activity, or any samples taken, or copy and photograph any records, reports, test results, or other information related solely to certification under this article or regulations adopted pursuant to this article.
(b) It shall be a misdemeanor for any person to prevent, interfere with, or attempt to impede in any way, any duly authorized representative of the department from undertaking the activities authorized by this section.
(c) If a laboratory that is seeking ELAP certification, NELAP accreditation, ELAP recertification, or NELAP reaccreditation refuses entry of a duly authorized representative during normal business hours for either an announced or unannounced onsite assessment, the certification, accreditation, recertification, or reaccreditation shall be denied or revoked.
(d) Refusal of a request by a NELAP approved accrediting authority, the department, or any employee, agent, or contractor of the department, for permission to inspect, pursuant to this section, the laboratory and its operations and pertinent records during the hours the laboratory is in operation shall result in denial or revocation of ELAP certification or NELAP accreditation.
(1) Enter and inspect a laboratory that is ELAP certified or NELAP accredited pursuant to this article or that has applied for ELAP certification or NELAP accreditation.
(2) Inspect and photograph any portion of the laboratory, equipment, any activity, or any samples taken, or copy and photograph any records, reports, test results, or other information related solely to certification under this article or regulations adopted pursuant to this article.
(b) It shall be a misdemeanor for any person to prevent, interfere with, or attempt to impede in any way, any duly authorized representative of the department from undertaking the activities authorized by this section.
(c) If a laboratory that is seeking ELAP certification, NELAP accreditation, ELAP recertification, or NELAP reaccreditation refuses entry of a duly authorized representative during normal business hours for either an announced or unannounced onsite assessment, the certification, accreditation, recertification, or reaccreditation shall be denied or revoked.
(d) Refusal of a request by a NELAP approved accrediting authority, the department, or any employee, agent, or contractor of the department, for permission to inspect, pursuant to this section, the laboratory and its operations and pertinent records during the hours the laboratory is in operation shall result in denial or revocation of ELAP certification or NELAP accreditation.
(a) Any laboratory that is ELAP certified or holds NELAP
accreditation or has applied for ELAP certification or NELAP
accreditation or for renewal of ELAP certification or NELAP
accreditation under this article shall analyze proficiency testing
samples, if these testing samples are available. The department shall
have the authority to contract with third parties for the provision
of proficiency testing samples for those laboratories that hold or
are applying for ELAP certification. The samples shall be tested by
the laboratory according to methods specifically approved for this
purpose by the United States government or the department, or
alternate methods of demonstrated adequacy or equivalence, as
determined by the department. Proficiency testing sample sets shall
be provided, when available, not less than twice, nor more than four
times, a year to each certified laboratory that performs analyses of
food for pesticide residues.
(b) (1) The department may provide, directly or indirectly, proficiency testing samples to a laboratory for the purpose of determining compliance with this article with or without identifying the department.
(2) When the department identifies itself, all of the following shall apply:
(A) The results of the testing shall be submitted to the department on forms provided by the department on or before the date specified by the department, and shall be used in determining the competency of the laboratory.
(B) There shall be no charge to the department for the analysis.
(3) When the department does not identify itself, the department shall pay the price requested by the laboratory for the analyses.
(c) If a certified or NELAP accredited laboratory submits proficiency testing sample results generated by another laboratory as its own, the certification or NELAP accreditation shall be immediately revoked.
(d) Laboratories shall obtain their proficiency testing samples from proficiency testing sample providers that meet NELAC standards. Laboratories shall bear the cost of any proficiency testing study fee charged for participation. Each laboratory shall authorize the providers of proficiency testing samples to release the report of the study results directly to the department, as well as to the laboratory.
(b) (1) The department may provide, directly or indirectly, proficiency testing samples to a laboratory for the purpose of determining compliance with this article with or without identifying the department.
(2) When the department identifies itself, all of the following shall apply:
(A) The results of the testing shall be submitted to the department on forms provided by the department on or before the date specified by the department, and shall be used in determining the competency of the laboratory.
(B) There shall be no charge to the department for the analysis.
(3) When the department does not identify itself, the department shall pay the price requested by the laboratory for the analyses.
(c) If a certified or NELAP accredited laboratory submits proficiency testing sample results generated by another laboratory as its own, the certification or NELAP accreditation shall be immediately revoked.
(d) Laboratories shall obtain their proficiency testing samples from proficiency testing sample providers that meet NELAC standards. Laboratories shall bear the cost of any proficiency testing study fee charged for participation. Each laboratory shall authorize the providers of proficiency testing samples to release the report of the study results directly to the department, as well as to the laboratory.
(a) An ELAP certified laboratory shall successfully analyze
proficiency testing samples for those fields of testing for which
they are certified, not less than once a year, where applicable.
Proficiency testing procedures shall be approved by the United States
government or by the department.
(b) A NELAP accredited laboratory shall participate in, and meet the success rate for, proficiency testing studies as required in the NELAP standards.
(c) The ELAP certified or NELAP accredited laboratory shall discontinue the analyses of samples for the fields of testing or subgroups which have been suspended for failure to comply with the proficiency testing requirements in this section.
(b) A NELAP accredited laboratory shall participate in, and meet the success rate for, proficiency testing studies as required in the NELAP standards.
(c) The ELAP certified or NELAP accredited laboratory shall discontinue the analyses of samples for the fields of testing or subgroups which have been suspended for failure to comply with the proficiency testing requirements in this section.
Whenever the department determines that any person has
violated or is violating this article or any certificate, regulation,
or standard issued or adopted pursuant to this article, the director
may issue an order directing compliance forthwith or directing
compliance in accordance with a time schedule set by the department.
If the department determines that a laboratory is in
violation of this article or any regulation or order issued or
adopted pursuant to this article, the department may, in addition to
suspension, denial, or revocation of the certificate or NELAP
accreditation, issue a citation to the owner of the laboratory. It
shall be the function of the approved accrediting authority to issue
citations. The Legislature finds and declares that since NELAC is a
standard setting body, it cannot, as such, enforce civil or criminal
penalties.
(a) The citation shall be served personally or by registered mail.
(b) Each citation shall be in writing and shall describe with particularity the nature of the violation, including a reference to the statutory provision, order, or regulation alleged to have been violated.
(c) The citation shall fix the earliest feasible time for elimination or correction of the condition constituting the violation.
(d) Citations issued pursuant to this section shall specify a civil penalty for each violation, not to exceed one thousand dollars ($1,000), for each day that the violation occurred.
(e) If the owner fails to correct a violation within the time specified in the citation, the department may assess a civil penalty as follows:
(1) For failure to comply with any citation issued for a violation of this article or a regulation, an amount not to exceed two hundred fifty dollars ($250) for each day that the violation continues beyond the date specified for correction in the citation.
(2) For failure to comply with any citation issued for violation of any department-issued order, an amount not to exceed two hundred dollars ($200) for each day the violation continues beyond the date specified for correction in the citation.
(a) The citation shall be served personally or by registered mail.
(b) Each citation shall be in writing and shall describe with particularity the nature of the violation, including a reference to the statutory provision, order, or regulation alleged to have been violated.
(c) The citation shall fix the earliest feasible time for elimination or correction of the condition constituting the violation.
(d) Citations issued pursuant to this section shall specify a civil penalty for each violation, not to exceed one thousand dollars ($1,000), for each day that the violation occurred.
(e) If the owner fails to correct a violation within the time specified in the citation, the department may assess a civil penalty as follows:
(1) For failure to comply with any citation issued for a violation of this article or a regulation, an amount not to exceed two hundred fifty dollars ($250) for each day that the violation continues beyond the date specified for correction in the citation.
(2) For failure to comply with any citation issued for violation of any department-issued order, an amount not to exceed two hundred dollars ($200) for each day the violation continues beyond the date specified for correction in the citation.
(a) Any person who operates a laboratory that performs work
that requires certification or NELAC accreditation under Section
25198, 25298.5, 25358.4, 110490, or 116390 of this code, or Section
13176 of the Water Code, who is not certified or NELAC accredited to
do so, may be enjoined from so doing by any court of competent
jurisdiction upon suit by the department.
(b) When the department determines that any person has engaged in, or is engaged in, any act or practice that constitutes a violation of this article, or any regulation or order issued or adopted thereunder, the department may bring an action in the superior court for an order enjoining these practices or for an order directing compliance and affording any further relief that may be required to ensure compliance with this article.
(b) When the department determines that any person has engaged in, or is engaged in, any act or practice that constitutes a violation of this article, or any regulation or order issued or adopted thereunder, the department may bring an action in the superior court for an order enjoining these practices or for an order directing compliance and affording any further relief that may be required to ensure compliance with this article.
Any person who operates a laboratory for the purposes
specified in Section 25198, 25298.5, 25358.4, or 116390 of this code,
or Section 13176 of the Water Code, shall report the full and
complete results of all detected contamination and pollutants to the
person or entity that submitted the material for testing.
(a) Any person who knowingly makes any false statement or
representation in any application, record, or other document
submitted, maintained, or used for purposes of compliance with this
article, may be liable, as determined by the court, for a civil
penalty not to exceed five thousand dollars ($5,000) for each
separate violation or, for continuing violations, for each day that
violation continues.
(b) Any person who operates a laboratory for purposes specified pursuant to Section 25198, 25298.5, 25358.4, 110490, or 116390 of this code, or Section 13176 of the Water Code that requires certification, who is not certified by the department pursuant to this article, may be liable, as determined by the court, for a civil penalty not to exceed five thousand dollars ($5,000) for each separate violation or, for continuing violations, for each day that violation continues.
(c) A laboratory that advertises or holds itself out to the public or its clients as having been certified for any of the fields of testing referred to in Section 100860 or 100862 without having a valid and current certificate in each field of testing identified by the advertisement or other representation may be liable, as determined by the court, for a civil penalty not to exceed one thousand dollars ($1,000) or, for continuing violations, for each day that violation continues.
(d) Each civil penalty imposed for any separate violation pursuant to this section shall be separate and in addition to any other civil penalty imposed pursuant to this section or any other provision of law.
(b) Any person who operates a laboratory for purposes specified pursuant to Section 25198, 25298.5, 25358.4, 110490, or 116390 of this code, or Section 13176 of the Water Code that requires certification, who is not certified by the department pursuant to this article, may be liable, as determined by the court, for a civil penalty not to exceed five thousand dollars ($5,000) for each separate violation or, for continuing violations, for each day that violation continues.
(c) A laboratory that advertises or holds itself out to the public or its clients as having been certified for any of the fields of testing referred to in Section 100860 or 100862 without having a valid and current certificate in each field of testing identified by the advertisement or other representation may be liable, as determined by the court, for a civil penalty not to exceed one thousand dollars ($1,000) or, for continuing violations, for each day that violation continues.
(d) Each civil penalty imposed for any separate violation pursuant to this section shall be separate and in addition to any other civil penalty imposed pursuant to this section or any other provision of law.
(a) Any person who knowingly does any of the following acts
may, upon conviction, be punished by a fine of not more than
twenty-five thousand dollars ($25,000) for each day of violation, by
imprisonment in a county jail not to exceed one year, or by both that
fine and imprisonment:
(1) Makes any false statement or representation in any application, record, report, or other document submitted, maintained, or used for the purposes of compliance with this article.
(2) Has in his or her possession any record required to be maintained pursuant to this article that has been altered or concealed.
(3) Destroys, alters, or conceals any record required to be maintained pursuant to this article.
(4) Withholds information regarding an imminent and substantial danger to the public health or safety when the information has been requested by the department in writing and is required to carry out the department's responsibilities pursuant to this article.
(b) A second or subsequent violation of subdivision (a) is punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code for 16, 20, or 24 months or in a county jail for not more than one year, by a fine of not less than two thousand dollars ($2,000) or more than fifty thousand dollars ($50,000) per day of violation, or by both that imprisonment and fine.
(c) An ELAP certified or NELAP accredited laboratory, upon suspension, revocation, or withdrawal of its ELAP certification or NELAP accreditation, shall do all of the following:
(1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, or their materials that contain reference to their past certification or accreditation status.
(2) Return its ELAP certificate or its NELAP accreditation to the department.
(3) Cease all testing of samples for regulatory purposes.
(d) The penalties cited in subdivisions (a) and (b) shall also apply to NELAP accredited laboratories.
(1) Makes any false statement or representation in any application, record, report, or other document submitted, maintained, or used for the purposes of compliance with this article.
(2) Has in his or her possession any record required to be maintained pursuant to this article that has been altered or concealed.
(3) Destroys, alters, or conceals any record required to be maintained pursuant to this article.
(4) Withholds information regarding an imminent and substantial danger to the public health or safety when the information has been requested by the department in writing and is required to carry out the department's responsibilities pursuant to this article.
(b) A second or subsequent violation of subdivision (a) is punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code for 16, 20, or 24 months or in a county jail for not more than one year, by a fine of not less than two thousand dollars ($2,000) or more than fifty thousand dollars ($50,000) per day of violation, or by both that imprisonment and fine.
(c) An ELAP certified or NELAP accredited laboratory, upon suspension, revocation, or withdrawal of its ELAP certification or NELAP accreditation, shall do all of the following:
(1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, or their materials that contain reference to their past certification or accreditation status.
(2) Return its ELAP certificate or its NELAP accreditation to the department.
(3) Cease all testing of samples for regulatory purposes.
(d) The penalties cited in subdivisions (a) and (b) shall also apply to NELAP accredited laboratories.
The remedies provided by this article are cumulative and
shall not be construed as restricting any remedy, provisional or
otherwise, provided by law for the benefit of any party, and no
judgment under this article shall preclude any party from obtaining
additional relief based upon the same facts.
The department may suspend or revoke any certificate issued
under of this article for any of the following reasons:
(a) Violation by the owner of the laboratory of any of the provisions of this article or any regulation adopted under this article.
(b) Aiding, abetting, or permitting the violation of any provision of this article or regulations adopted under this article.
(c) Proof that the certificateholder or owner has made false statements in any material regard on the application for certification.
(d) Conviction of an owner of the laboratory of any crime that is substantially related to the qualifications or duties of that owner and that is related to the functions of the laboratory. For purposes of this subdivision, a "conviction" means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Action to revoke or suspend the certificate may be taken when: (1) the time for appeal has elapsed, or (2) the judgment of conviction has been affirmed on appeal, or (3) when an order granting probation is made suspending the imposition of sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty and entry of a plea of not guilty, or (4) setting aside a verdict of guilty, or (5) dismissing the accusation, information, or indictment. The department shall take into account all judicial decisions on rehabilitation furnished by the owner of the laboratory.
(a) Violation by the owner of the laboratory of any of the provisions of this article or any regulation adopted under this article.
(b) Aiding, abetting, or permitting the violation of any provision of this article or regulations adopted under this article.
(c) Proof that the certificateholder or owner has made false statements in any material regard on the application for certification.
(d) Conviction of an owner of the laboratory of any crime that is substantially related to the qualifications or duties of that owner and that is related to the functions of the laboratory. For purposes of this subdivision, a "conviction" means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Action to revoke or suspend the certificate may be taken when: (1) the time for appeal has elapsed, or (2) the judgment of conviction has been affirmed on appeal, or (3) when an order granting probation is made suspending the imposition of sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty and entry of a plea of not guilty, or (4) setting aside a verdict of guilty, or (5) dismissing the accusation, information, or indictment. The department shall take into account all judicial decisions on rehabilitation furnished by the owner of the laboratory.
(a) The department shall revoke, in whole or in part, the
accreditation of a NELAP accredited laboratory for either of the
following reasons:
(1) Failure to submit an acceptable corrective action report in response to a deficiency report, and failure to implement corrective action related to any deficiencies found during a laboratory assessment. The laboratory may submit two corrective actions within the time limits specified by the accrediting authority.
(2) Failure to successfully analyze and report proficiency testing sample results pursuant to Chapter 2 of the NELAC standards.
(b) The department shall revoke, in whole, the accreditation of a NELAP accredited laboratory for any of the following reasons:
(1) Failure to respond with a corrective action report within the required 30-day period.
(2) Failure to participate in the proficiency testing program, as required by Chapter 2 of the NELAC standards.
(3) Submittal of proficiency test sample results generated by another laboratory as its own.
(4) Misrepresentation of any material fact pertinent to receiving or maintaining accreditation.
(5) Denial of entry during normal business hours for an onsite assessment, as required by Chapter 3 of the NELAC standards.
(6) Conviction of charges for the falsification of any report of, or that relates to, a laboratory analysis.
(c) The department may also revoke, in whole, a laboratory's accreditation for failure to remit the accreditation fees within the time limit established by the accrediting authority.
(d) After correcting the reason or reasons for revocation, the NELAP accredited laboratory may reapply for accreditation no sooner than six months from the official date of revocation.
(e) A laboratory's NELAP accreditation shall not be revoked without the right to due process, as required by Chapter 4 of the NELAC standards.
(1) Failure to submit an acceptable corrective action report in response to a deficiency report, and failure to implement corrective action related to any deficiencies found during a laboratory assessment. The laboratory may submit two corrective actions within the time limits specified by the accrediting authority.
(2) Failure to successfully analyze and report proficiency testing sample results pursuant to Chapter 2 of the NELAC standards.
(b) The department shall revoke, in whole, the accreditation of a NELAP accredited laboratory for any of the following reasons:
(1) Failure to respond with a corrective action report within the required 30-day period.
(2) Failure to participate in the proficiency testing program, as required by Chapter 2 of the NELAC standards.
(3) Submittal of proficiency test sample results generated by another laboratory as its own.
(4) Misrepresentation of any material fact pertinent to receiving or maintaining accreditation.
(5) Denial of entry during normal business hours for an onsite assessment, as required by Chapter 3 of the NELAC standards.
(6) Conviction of charges for the falsification of any report of, or that relates to, a laboratory analysis.
(c) The department may also revoke, in whole, a laboratory's accreditation for failure to remit the accreditation fees within the time limit established by the accrediting authority.
(d) After correcting the reason or reasons for revocation, the NELAP accredited laboratory may reapply for accreditation no sooner than six months from the official date of revocation.
(e) A laboratory's NELAP accreditation shall not be revoked without the right to due process, as required by Chapter 4 of the NELAC standards.
Proceedings for the suspension or revocation of a
certificate under this article shall be conducted in accordance with
Section 100171, and the department shall have all powers granted
pursuant to that section.
(a) The department may temporarily suspend, in whole or in
part, ELAP certification or NELAP accreditation prior to any hearing,
when it has determined that this action is necessary to protect the
public. The department shall notify the owner of the temporary
suspension and the effective date thereof and at the same time shall
serve the owner with an accusation. Upon receipt of a notice of
defense by the owner, the matter shall be set for hearing within 15
calendar days. The hearing shall be held as soon as possible but no
later than 30 calendar days after receipt of the notice. The
temporary suspension shall remain in effect until the hearing is
completed and the department has made a final determination on the
merits. However, the temporary suspension shall be deemed vacated if
the department fails to make a final determination on the merits
within 60 calendar days after the original hearing has been
completed.
(b) During the suspension, the laboratory shall discontinue the analysis of samples for the specified fields of testing.
(b) During the suspension, the laboratory shall discontinue the analysis of samples for the specified fields of testing.
Fees and civil penalties collected under this article shall
be deposited in the Environmental Laboratory Improvement Fund, that
is hereby created. Moneys in the fund shall be available for
expenditure by the department for the purposes of this article, upon
appropriation by the Legislature.
