W. Va. Code R. § 47-32-3

Current through Register Vol. XLI, No. 45, November 8, 2024

Section 47-32-3 - Certification Program; Application, Procedures, and Requirements

3.1. Requirements of Certification.

3.1.1. With the exception of those tests not normally performed in a laboratory proper, all sample analyses required by order of the Department or performed for the purpose of determining compliance with chemical, microbiological, aquatic toxicity and radiological requirements of the State's covered statutory programs must be performed in laboratories certified for this purpose pursuant to this rule. Analyses performed in laboratories not so certified shall not be accepted by the Department as being in compliance with the requirements, rules or orders of the Department. All analyses not performed in a laboratory proper must be performed by personnel under the direction of a supervisor from a certified laboratory.

3.1.2. Laboratories doing business in other states where a state certifying agency grants reciprocal certification, approval, or other authorization to laboratories located in West Virginia, and which is certified, approved or authorized by the agency of that state having primary certification responsibility under Federal programs delegated to such other state under conditions equivalent to those required by this rule, are considered to be certified for the purpose of this rule once they have complied with the provisions of Section 3.4. Laboratories doing business in other states where certification is not required, and who are not certified in another state, may be considered for certification by following the conditions and requirements stated in Section 3.3.

3.1.3. Only laboratories certified pursuant to this rule or maintained by the EPA may be called West Virginia Certified Environmental Laboratories and no laboratory may adopt any name or make any oral or written statement intended or likely to mislead the public with respect to its certification status.

3.2. Categories of Certification. -- A laboratory applying for certification in one or more of the following categories must demonstrate acceptable performance on proficiency test samples for all matrices, where available, and meet all other requirements of this rule. The laboratory certificate, including the list of certified parameters, will specify the categories and the parameters within each category for which the laboratory is certified and it must be displayed in a location visible to the public. Tests for all categories, except Aquatic Toxicity, must be conducted in accordance with the method and procedures specified in the Code of Federal Regulations, Chapter 40 as applicable or other methods that may be approved by EPA or the Secretary. The certification categories are:

3.2.1. Nonpotable Water Trace Metals;

3.2.2. Nonpotable Water Inorganic Nonmetals;

3.2.3. Nonpotable Water Volatile Organic Chemicals;

3.2.4. Nonpotable Water Extractable and Semi-volatile Organic Chemicals;

3.2.5. Nonpotable Water Dioxin and Dibenzofuran;

3.2.6. Nonpotable Water Microbiology, comprising tests for Coliform Bacteria, Fecal Streptococci, Pathogenic Bacteria, Plate counts, Viruses, Parasites and Parasite ova;

3.2.7. Whole Effluent Toxicity, testing which must be conducted in accordance with the methods and procedures specified in 40 CFR 136;

3.2.8. Nonpotable Water Radiochemistry;

3.2.9. Hazardous Waste Characteristics, including Corrosivity, Ignitability, Reactivity, Extraction Procedure Toxicity, and Toxicity Characteristic Leaching Procedure, or other tests or analyses designated by the Secretary;

3.2.10. Solid and Chemical Trace Metals;

3.2.11. Solid and Chemical Inorganic Nonmetals;

3.2.12. Solid and Chemical Volatile Organic Chemicals;

3.2.13. Solid and Chemical Extractable and Semi-volatile Chemicals;

3.2.14. Solid and Chemical Dioxin and Dibenzofuran;

3.2.15. Solid and Chemical Microbiology; and

3.2.16. Solid and Chemical Radiochemistry.

3.3. Application Procedures and Requirements for Laboratories Located in West Virginia.

3.3.1. A person operating a laboratory in West Virginia who wants to be certified in one or more of the categories and parameters thereof or, who if already certified, wants to add a category or a parameter within a category, must apply for certification to the West Virginia Department of Environmental Protection, Quality Assurance Program, refer to subsection 1.9 for the address. The applicant shall submit the appropriate fee with the application for certification.

3.3.2. An application for certification is acceptable when a complete application is submitted. This includes the appropriate fee, and the information requirements of this rule for the category, categories or parameter(s) for which certification is requested. Acceptance of a complete application does not authorize the laboratory to perform analyses regulated by this rule. The applicant will be notified if the application is not acceptable and the laboratory inspected to determine if it is in compliance with the requirements of this rule prior to the issuance of certification.

3.3.3. An application will be rejected without prejudice for not being a complete application.

3.3.4. Proficiency test samples will be an element of the laboratory evaluation. Proficiency testing will be in accordance with subsection 3.10. The laboratory must receive acceptable scores on two separate proficiency test studies prior to an on-site inspection being performed. Certified laboratories that desire to include additional parameters within previously certified categories must demonstrate satisfactory results for proficiency test samples for these additional parameters.

3.3.5. The results of the analysis of proficiency test samples shall be considered in determining whether the certification of the laboratory should be granted, renewed, denied, revoked, or suspended. Certification may be granted only for those parameters for which the laboratory performs acceptably.

3.3.6. An applicant for certification who either does not perform acceptably on the proficiency test samples or does not otherwise meet the requirements of this rule shall be notified that the requirements for certification have not been met.

3.3.6.a. Applicants receiving a notification that certification requirements have not been met may not reapply for certification until the laboratory assures the Quality Assurance Office in writing that corrective actions have been taken and documented that bring the laboratory into compliance with this rule.

3.3.6.b. Owners, principal officers, managers or supervisors of a laboratory, for which certification has been denied, may not reapply for certification of this same facility by simply changing the company or laboratory name.

3.3.6.c. Certification is transferrable. A laboratory facility must notify the Department in writing at the address listed in subsection 1.9 that the facility is being sold or has a change of principal officer(s), manager(s) or supervisor(s) within 30 days of the change or activity.

3.3.7. Certifications may contain conditions requiring correction of minor deficiencies identified by the Quality Assurance Officer by a date or dates specified therein.

3.4. Application Procedures and Requirements for Laboratories Not Located in West Virginia.

3.4.1. Owners of laboratories located in a state other than West Virginia, which have been certified, approved or otherwise authorized by that state's agency having primary certification, approval or authorization responsibility for laboratory certification programs with conditions equivalent to those required by this rule, and who have entered into a reciprocity agreement with West Virginia, and who wish to perform analyses covered by this rule for West Virginia clients shall:

3.4.1.a. Annually complete the application form provided by the Department's Quality Assurance Office;

3.4.1.b. Have the form certified by the state agency having primary certification authorization/enforcement responsibility; and

3.4.1.c. Return the form to the Quality Assurance Office of West Virginia at the address listed in subsection 1.9.

3.4.2. The application will be reviewed and if found to be complete the laboratory will be certified or recertified.

3.4.3. If the laboratory's certification, approval or authorization is revoked by the state agency having primary certification, approval or authorization responsibility, the West Virginia certification is automatically canceled for the same parameter(s) as has been revoked in the other state. The laboratory manager shall notify the West Virginia Quality Assurance Office and all clients in West Virginia of the revocation within 48 hours of receipt of notice of revocation.

3.4.4. The owner of a laboratory in a state other than West Virginia which is not certified by that state or is certified under conditions not equivalent to those required by this rule and who wishes to perform analyses for West Virginia clients may apply for certification in accordance with the procedure set forth in subsection 3.3 of this rule. In addition, prior to conducting the on-site laboratory inspection, the laboratory shall submit to the Quality Assurance Office a per diem sum the Department determines to be sufficient to cover the travel, room, and board expenses of the certification inspector(s).

3.5. Renewal of Certification. -- Applications for renewal of certification must be submitted, on forms provided therefore, no later than 180 days before the expiration date of certification, and accompanied by the appropriate fee. A laboratory submitting an application for renewal of certification may continue to operate under the previous certification until the Quality Assurance Office notifies the laboratory of the approval or denial of renewal.

3.6. Fees.

3.6.1. Owners of Laboratories applying for certification or renewal of certification, shall submit the appropriate fee obtained from the annual fee schedule specified in Table 1 for each category in which the laboratory seeks certification for one or more parameters, along with the required application materials. Fees are nonrefundable.

3.6.2. Laboratories owned or operated by the State of West Virginia or an agency of the Federal Government are exempt from the above fees, except in situations addressed in paragraph 3.6.2.a, but shall make appropriate application for certification in accordance with the other provisions of this rule.

3.6.2.a. In situations where a laboratory under this subdivision is conducting analyses for a fee, an appropriate certification fee will be assessed.

3.6.3. All application fees collected under this rule will be paid into a special state treasury fund designated the "Environmental Laboratory Certification Fund" which will be used to defray the cost of administering this rule.

3.7. Required Laboratory Personnel Qualifications.

3.7.1. Each laboratory must have one individual designated as the person responsible or in charge and irrespective of any local title or designation, is herein referred to as the laboratory manager.

3.7.2. Current employee records must include a resume documenting each employee's training, degrees held, experience, duties, and date(s) of relevant employment. This provision is applicable only to the employee's laboratory and environmental sampling work history. Table 2 lists the minimum education and experience requirements.

3.7.3. Laboratory supervisors who are also laboratory technicians and who do not have the required laboratory experience will be considered a Supervisor-in-Training and must have their work reviewed by an individual meeting the above education and experience requirements for supervisors.

3.7.4. Technicians holding a West Virginia Environmental Training Center Wastewater Laboratory Technician certificate meet the education and experience requirements of this rule only in the conduct of analyses while employed at a Publicly Owned Treatment Works (POTW).

3.8. Duties and Responsibilities of Laboratory Personnel.

3.8.1. The laboratory manager or his designee will administer the operations of the laboratory including the approval of test and analytical results.

3.8.2. Each laboratory supervisor shall provide personal and direct supervision for personnel and for the reporting of test and analytical results.

3.9. Management of Laboratories.

3.9.1. A certified laboratory may offer as a service those laboratory tests, analyses, or procedures that are within the category or categories for which it is certified.

3.9.2. A laboratory that is certified shall only report test and analytical data for samples which are properly labeled, and for which there is reasonable assurance the samples have been collected, preserved, stored and transported in such a manner as to assure identity, stability of the sample, and proper analysis.

3.10. Proficiency Testing.

3.10.1. Except when determined by the Quality Assurance Office that an appropriate performance evaluation test is not readily available, all certified laboratories or laboratories seeking certification shall participate in a proficiency testing program covering all tests, matrices, and analyses made available within the category, categories or parameter(s) for which the laboratory is certified or seeks certification. The laboratory must participate in two studies per certification year at a frequency of one study every six (6) months.

3.10.2. Each certified laboratory or laboratory applying for certification must obtain proficiency test samples from an approved provider for each parameter and matrix for which certification is requested. The list of approved providers is located at http://www.a2la.org/dirsearch/nelacptproviders.cfm.

3.10.3. Laboratories certified or those seeking certification must test or analyze the proficiency test samples and submit the results to the Quality Assurance Office or its authorized agent, as appropriate, within the time frame allowed each participant testing that set of samples for evaluation.

3.10.3.a. A laboratory may not send proficiency test samples to another laboratory for testing.

3.10.3.b. A laboratory shall not knowingly receive proficiency test samples from any laboratory seeking certification or certified by this office.

3.10.3.c. A laboratory shall not discuss proficiency test sample data with any other laboratory for any purpose.

3.10.3.d. Any laboratory found in violation of 3.10.3a, 3.10.3.b, or 3.10.3.c will be denied certification and not allowed to reapply for certification for a period of five (5) years from the date of the denial.

3.10.4. The laboratory will have satisfied the requirements for testing for a parameter when it receives an 'Acceptable' evaluation for that parameter, in two of the last three proficiency test studies.

3.10.5. The laboratory will be informed of the results of each evaluation by the proficiency test provider. For those parameters which a laboratory has not successfully completed the proficiency test after three attempts, the laboratory will be reevaluated upon written request.

3.10.6. Acceptance limits for proficiency tests will be established according to the USEPA document "National Standards for Water Proficiency Testing, Criteria Document." For analytes and matrices not found in this document, limits will be established in accordance with the procedures set forth by the current National Environmental Laboratory Accreditation Conference (NELAC).

3.10.7. The laboratory will have three separate opportunities to acceptably analyze proficiency test samples for any parameter for which the laboratory seeks certification. The laboratory need only repeat proficiency tests for those parameters for which the laboratory has failed to perform acceptably. Parameters for Organic Samples shall mean a method, or method subdivision (i.e. Volatiles, Extractables, BTEX, etc.). Laboratories that fail to successfully analyze two of three different sets or rounds of proficiency test samples in the time period allotted will not be certified for the failed parameters until two consecutive sets or rounds have been successfully analyzed.

3.10.8. This rule incorporates by reference the 2003 National Environmental Laboratory Accreditation Conference (NELAC) Proficiency Testing standard, Chapter 2 with appendices for the purposes of Proficiency Testing Criteria for Laboratory Certification.

3.11. Laboratory Inspections.

3.11.1. As a condition of obtaining and maintaining certification, a laboratory will permit and facilitate inspections by personnel of the Department. This inspection will include the physical facilities as well as laboratory records and reports.

3.11.2. The Department will conduct at least one on-site inspection of a laboratory seeking certification to determine whether or not the laboratory meets the Quality Assurance Office standards as set forth in this rule.

3.11.3. Regular inspections of laboratories certified in accordance with this rule will be conducted during reasonable hours. These inspections will be conducted annually or as determined by the Secretary, however, in no situation may more than two years elapse between inspections.

3.11.4. Authorized representatives of the Department may make inspections of a certified laboratory whenever the Department in its discretion considers such inspections necessary. A laboratory's refusal to allow entry to the Department's representative will be grounds for denial or revocation of certification.

3.11.5. During inspections, consideration will be given to staff competence, working conditions, tests or analytical methods used, quality control procedures, quality assurance programs, maintenance of records and compliance with the requirements of this rule.

3.11.6. The laboratory will be furnished with a copy of the inspection report which will list deficiencies found.

3.12. Cancellation, Suspension, and Revocation of Certification.

3.12.1. Any certified laboratory may cancel its certification in any category or parameter by notifying the Quality Assurance Office in writing of the laboratory's decision to cancel its certification. This cancellation notification will not entitle the laboratory to any refund of fees paid.

3.12.1.a. If the laboratory wishes to cancel the entire certification, all categories and parameters, the laboratory will enclose its Environmental Laboratory Certificate with the letter of notification.

3.12.2. A laboratory's certification may be suspended for failure to correct deficiencies within the specified timeframe.

3.12.3. A laboratory's certification may be suspended for failure to correct proficiency test sample failures.

3.12.4. A laboratory's certification may be revoked if the laboratory commits any falsification relating to certification, testing, or reporting of analytical results or for failing to comply with the provisions in 3.10.

3.13. Effect and Duration of Suspension and Revocation.

3.13.1. The results of any tests or analyses performed after the effective date of a suspension or revocation order for any category or parameter will not be accepted by the Department as being in compliance with the requirements of the Covered Statutory Programs as defined in subsection 2.20.

3.13.2. Suspension or revocation will not be withdrawn until the basis for the suspension or revocation has been eliminated or rectified.

3.13.3. Any laboratory having its certification suspended or revoked must notify all clients of the suspension or revocation.

3.14. Notice of Changes -- In the event there are any changes in the name, location, ownership, address, telephone number or supervisory personnel of the laboratory to which the provisions of this rule apply, then the laboratory will immediately submit written notice thereof to the Department. For supervisory personnel this provision applies only to those whose responsibilities include analyses that must be made in compliance with this rule.

W. Va. Code R. § 47-32-3