15A NCAC 02H .0805. CERTIFICATION AND RENEWAL OF CERTIFICATION

(a)  Prerequisites and requirements for Certification.  The following requirements must be met prior to certification.  Once certified, failure to comply with any of the following items will be a violation of certification requirements.  All "Field Parameter" only facility requirements are located in Paragraph (g) of this Rule.

(1)           Laboratory Procedures.  Analytical methods, sample preservation, sample containers and sample holding times shall conform to those requirements found in 40 CFR-136.3; Standard Methods for the Examination of Water and Wastewater, 18th Edition; or Test Methods for Evaluating Solid Waste, SW 846, Third Edition.  These and subsequent amendments and editions are incorporated by reference.  This material is available for inspection at the State Laboratory, 4405 Reedy Creek Road, Raleigh, North Carolina, 27607.  Copies of the Code of Federal Regulations, 40 CFR Part 136, may be obtained for a cost of forty-two dollars ($42.00), from the Superintendent of Documents, U.S. Government Printing Office (GPO), Superintendent of Public Documents, Washington, DC, 20402.  The publication number is 869-042-00148-6. Standard Methods for the Examination of Water and Waste, is available for purchase from the American Water Works Association (AWWA), 6666 West Quincy Avenue, Denver, CO 80235.  The costs are as follows: 18th Edition -one hundred sixty dollars ($160.00), 19th Edition - one hundred eighty dollars ($180.00), 20th Edition - two hundred dollars ($200.00). Copies of Test Methods for Evaluating Solid Waste, SW 846, Third Edition may be purchased for a cost of three hundred sixty seven dollars ($367.00) from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402.  Vector Attraction Reduction Options shall be Control of Pathogens and Vector Attraction in Sewage Sludge; EPA/625/R-92/013, Chapter 8. The document is available from US EPA; Office of Research and Development, Washington, NC 20460 at no cost.  The method for Total Petroleum Hydrocarbons shall be the California Gas Chromatograph Method, Eisenberg, D.M., and others, 1985, Guidelines for Addressing Fuel Leaks: California Regional Quality Control Board San Francisco Bay Region.  The method for Total Petroleum Hydrocarbons is available from the State Laboratory at no cost.  The methods for Volatile Petroleum Hydrocarbons and Extractable Petroleum Hydrocarbons shall be Massachusetts Department of Environmental Protection, Method for the Determination of Volatile Petroleum Hydrocarbons (VPH) and Method for the Determination of Extractable Petroleum Hydrocarbons (EPH); January, 1998.  The Director may approve other analytical procedures that have been demonstrated to produce verifiable and repeatable results and that have a widespread acceptance in the scientific community.

(2)           Performance Evaluations.  Annually, each certified laboratory must demonstrate acceptable performance on evaluation samples as required by these Rules.

(A)          Municipal and Industrial laboratories must participate in the annual Environmental Protection Agency Discharge Monitoring Report Quality Assurance (EPA/DMR/QA) Study by analyzing performance evaluation samples obtained from an accredited vendor as unknowns, and reporting data produced to the State.  The laboratory is responsible for submitting acceptable results for all parameters listed on their certificate.

(B)          Commercial laboratories must participate annually in water pollution studies by analyzing performance evaluation samples obtained from an accredited vendor as unknowns, and reporting data produced to the State.  The laboratory is responsible for submitting acceptable results for all parameters listed on their certificate.  When two samples for the same parameter are submitted and analyzed at the same time, an unacceptable result on one or both samples will be considered the first unacceptable result for certification purposes and a rerun sample must be submitted.

(C)          Laboratories requesting initial certification must submit an acceptable performance sample result for each parameter for which performance samples are available.  Laboratories that submit two unacceptable results for a particular parameter must then submit two consecutive acceptable results for that parameter prior to initial certification.

(D)          If performance samples are not available for a parameter, certification for that parameter will be based on the proper use of the approved procedure, the on-site inspection, and adherence to the other requirements in this Section.  Analysis of split samples may also be required.

(3)           Supervisory Requirements.

(A)          The supervisor of a commercial laboratory must have a minimum of a B.S. or A.B. degree in chemistry or closely related science curriculum from an accredited college or university plus a minimum of two years laboratory experience in analytical chemistry, or a two year associate degree from an accredited college, university, or technical institute in chemistry technology, environmental sciences, or closely related science curriculum plus a minimum of four years experience in analytical chemistry.

(B)          The supervisor of a municipal or industrial waste water treatment plant laboratory must have a minimum of a B.S. or A.B. degree in chemistry or closely related science curriculum from an accredited college or university plus a minimum of six months laboratory experience in analytical chemistry, or a two year associate degree from an accredited college, university, or technical institute in chemistry technology, environmental sciences, or closely related science curriculum plus a minimum of two years experience in analytical chemistry.  Non-degree supervisors must have at least six years laboratory experience in analytical chemistry.

(C)          All laboratory supervisors are subject to review by the State Laboratory.  One person may serve as supervisor of no more than two laboratories.  The supervisor shall provide personal and direct supervision of the technical personnel and be held responsible for the proper performance and reporting of all analyses made for these Rules.  The supervisor must work in the laboratory or visit the laboratory once each day of normal operations.  If the supervisor is to be absent, the supervisor shall arrange for a substitute capable of insuring the proper performance of all laboratory procedures, however, the substitute supervisor cannot be in charge for more than six consecutive weeks.  Existing laboratory supervisors that do not meet the requirements of this Rule may be accepted after review by the State Laboratory and meeting all other certification requirements. Previous laboratory-related performance will be considered when reviewing the qualifications of a potential laboratory supervisor.

(4)           Laboratory Manager.  Each laboratory must designate a laboratory manager and include his name and title on the application for certification.  The laboratory manager shall be administratively above the laboratory supervisor and will be in responsible charge in the event the laboratory supervisor ceases to be employed by the laboratory and will be responsible for filling the laboratory supervisor position with a replacement qualified pursuant to these Rules.  At commercial laboratories, where the owner is the laboratory supervisor, the laboratory manager and laboratory supervisor may be the same person if there is no one administratively above the laboratory supervisor.

(5)           Application. Each laboratory requesting initial state certification shall submit an application in duplicate, accompanied by the application fee and the laboratory's Quality Assurance Manual to the State Laboratory.  Separate application and certification shall be required for all laboratories maintained on separate premises even though operated under the same management; however, separate certification is not required for separate buildings on the same or adjoining grounds.  After receiving a completed application and prior to issuing certification, a representative of the State Laboratory may visit each laboratory to verify the information in the application and the adequacy of the laboratory.

(6)           Facilities and equipment.  Each laboratory requesting certification must contain or be equipped with the following:

(A)          A minimum of 150 sq. ft. of laboratory space;

(B)          A minimum of 12 linear feet of laboratory bench space;

(C)          A sink with hot and cold water;

(D)          An analytical balance capable of weighing 0.1 mg, mounted on a shock proof table;

(E)           A refrigerator of adequate size to store all samples and maintain temperature of four degrees Celsius;

(F)           A copy of each approved analytical procedure being used in the laboratory;

(G)          A source of distilled or deionized water that will meet the minimum criteria of the approved methodologies;

(H)          Glassware, chemicals, supplies, and equipment required to perform all analytical procedures included in their certification.

(7)           Analytical Quality Control Program.  Each laboratory shall develop and maintain a document outlining the analytical quality control practices used for the parameters included in their certification.  Supporting records shall be maintained as evidence that these practices are being effectively carried out.  The quality control document shall be available for inspection by the State Laboratory. The following are requirements for certification and must be included in each certified laboratory's quality control program:

(A)          All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request.

(B)          Excluding Oil and Grease, all residue parameters, leachate extractions, residual chlorine, and coliform, analyze one known standard in addition to calibration standards each day samples are analyzed to document accuracy.  Analyze one suspended residue, one dissolved residue, one residual chlorine and one oil and grease standard quarterly.  For residual chlorine, all calibration standards required by the approved procedure in use and by EPA must be analyzed.

(C)          Except for Oil and Grease (EPA Method 413.1), settleable solids or where otherwise specified in an analytical method, analyze five percent of all samples in duplicate to document precision.  Laboratories analyzing less than 20 samples per month must analyze at least one duplicate each month samples are analyzed.

(D)          Any quality control procedures required by a particular approved method shall be considered as required for certification for that analysis.

(E)           All quality control requirements in these Rules as set forth by the State Laboratory.

(F)           Any time quality control results indicate an analytical problem, the problem must be resolved and any samples involved must be rerun if the holding time has not expired.

(G)          All analytical records must be available for a period of five years.  Records, which are stored only on electronic media, must be maintained and supported in the laboratory by all hardware and software necessary for immediate data retrieval and review.

(H)          All laboratories must use printed laboratory bench worksheets that include a space to enter the signature or initials of the analyst, date of analyses, sample identification, volume of sample analyzed, value from the measurement system, factor and final value to be reported and each item must be recorded each time samples are analyzed.  The date and time BOD and coliform samples are removed from the incubator must be included on the laboratory worksheet.

(I)            For analytical procedures requiring analysis of a series of standards, the concentrations of these standards must bracket the concentration of the samples analyzed.  One of the standards must have a concentration equal to the laboratory's lower reporting concentration for the parameter involved.  For metals by AA or ICP, a series of at least three standards must be analyzed along with each group of samples.  For colorimetric analyses, a series of five standards for a curve prepared annually or three standards for curves established each day or standards as set forth in the analytical procedure must be analyzed to establish a standard curve.  The curve must be updated as set forth in the standard procedures, each time the slope changes by more than 10 percent at mid-range, each time a new stock standard is prepared, or at least every twelve months.  Each analyst performing the analytical procedure must produce a standard curve.

(J)            Each day an incubator, oven, waterbath or refrigerator is used, the temperature must be checked, recorded, and initialed.  During each use, the autoclave maximum temperature and pressure must be checked, recorded, and initialed.

(K)          The analytical balance must be checked with one class S, or equivalent, standard weight each day used and at least three standard weights quarterly.  The values obtained must be recorded in a log and initialed by the analyst.

(L)           Chemicals must be dated when received and when opened.  Reagents must be dated and initialed when prepared.

(M)         A record of date collected, time collected, sample collector, and use of proper preservatives must be maintained.  Each sample must clearly indicate the State of North Carolina collection site on all record transcriptions.

(N)          At any time a laboratory receives samples which do not meet sample collection, holding time, or preservation requirements, the laboratory must notify the sample collector or client and secure another sample if possible.  If another sample cannot be secured, the original sample may be analyzed but the results reported must be qualified with the nature of the infraction(s) and the laboratory must notify the State Laboratory about the infraction(s).  The notification must include a statement indicating corrective actions taken to prevent the problem for future samples.

(O)          All thermometers must meet National Institute of Standards and Technology (NIST) specifications for accuracy or be checked, at a minimum annually, against a NIST traceable thermometer and proper corrections made.

(8)           Decertification Requirements.  Municipal and industrial laboratories that cannot meet initial certification requirements must comply with the Decertification Requirements as set forth in Rule .0807(e) of this Section.

(b)  Issuance of Certification.

(1)           Upon compliance with these Rules, certification shall be issued by the Director, Division of Water Quality, Department of Environment and Natural Resources or his delegate, for each of the applicable parameters requested within 30 days.

(2)           Initial certifications shall be issued for prorated time periods to schedule all certification renewals on the first day of January and shall be valid for one year.

(c)  Maintenance of Certification.

(1)           To maintain certification for each parameter, a certified laboratory must analyze up to four performance evaluation samples per parameter per year submitted by an accredited vendor as an unknown.  Laboratories submitting unacceptable results on a performance evaluation sample may be required to analyze more than four samples per year.

(2)           In addition, the State Laboratory may request that samples be split into two equal representative portions, one part going to the State and the other to the certified laboratory for analysis.

(3)           The State laboratory may submit or require clients to submit blind performance samples or split samples under direction of State Laboratory personnel.

(4)           A certified laboratory shall be subject to periodic announced or unannounced inspections during the certification period and shall make time and records available for inspections and must supply copies of records for any investigation upon written request by the State Laboratory.

(5)           A certified laboratory must provide the State Laboratory with written notice of laboratory supervisor or laboratory manager changes within 30 days of such changes.

(6)           A certified laboratory must submit written notice of any changes of location, ownership, address, name or telephone number within 30 days of such changes.

(7)           A certified laboratory must submit a written amendment to the certification application each time that changes occur in methodology, reporting limits, and major equipment.  The amendment must be received within 30 days of such changes.

(d)  Certification Renewals

(1)           Certification renewals of laboratories shall be issued for one year.

(e)  Data reporting.

(1)           Certified commercial laboratories must make data reports to their clients that are signed by the laboratory supervisor.  This duty may be delegated in writing; however, the responsibility shall remain with the supervisor.

(2)           Whenever a certified commercial laboratory refers or subcontracts samples to another certified laboratory for analyses, the referring laboratory must supply the date and time samples were collected to insure holding times are met. Subcontracted samples must clearly indicate the State of North Carolina as the collection site on all record transcriptions. Laboratories may subcontract sample fractions, extracts, leachates and other sample preparation products provided that all Rules and requirements of 15A NCAC 02H .0800 are documented. The initial client requesting the analyses must receive the original or a copy of the report made by the laboratory that performs the analyses.

(3)           All uncertified data must be clearly documented as such on the benchsheet and on the final report.

(f)  Discontinuation of Certification.

(1)           A laboratory may discontinue certification for any or all parameters by making a written request to the State Laboratory.

(2)           After discontinuation of certification, a laboratory may be recertified by meeting the requirements for initial certification; however, laboratories that discontinue certification during any investigation shall be subject to Rule .0808 of this Section.

(g)  Prerequisites and requirements for Field Parameter Certification.  Only the following requirements must be met prior to certification for Field Parameter Laboratories.  Once certified, failure to comply with any of the following items will be a violation of certification requirements.

(1)           Data pertinent to each analysis must be maintained for five years. Certified Data must consist of date collected, time collected, sample site, sample collector, and sample analysis time. The field benchsheets must provide a space for the signature or initials of the analyst, and proper units of measure for all analyses.

(2)           A record of instrument calibration where applicable, must be filed in an orderly manner so as to be readily available for inspection upon request.

(3)           A copy of each approved analytical procedure must be available to each analyst.

(4)           Each facility must have glassware, chemicals, supplies, equipment, and a source of distilled or deionized water that will meet the minimum criteria of the approved methodologies.

(5)           Supervisors of laboratories certified for Field Parameters only must meet the requirements of Subparagraph (a)(3)(A) or (a)(3)(B) of this Section, or possess a chemistry or related degree with two years of related environmental experience, or hold any Biological Water Pollution Control System Operator's Certification as defined by 15A NCAC 08G.

(6)           Application: Each Field Parameter Laboratory shall submit an application in duplicate.

(7)           Performance Evaluations.  Each Field Parameter Laboratory must participate in an annual quality assurance study by analyzing performance evaluation samples obtained from an accredited vendor as unknowns.  If performance evaluations are not available for a parameter, certification for that parameter may be based on the proper use of the approved procedure as determined by an announced or unannounced on-site inspection.

(8)           Decertification and Civil Penalties.  A laboratory facility can be decertified for infractions as outlined in Rule .0807 of this Section.

(9)           Recertification.  A laboratory facility can be recertified in accordance with Rule .0808 of this Section.

 

History Note:        Authority G.S. 143‑215.3(a)(1); 143‑215.3(a)(10);

Eff. February 1, 1976;

Amended Eff. July 1, 1988; July 1, 1985; December 1, 1984; November 1, 1978;

RRC Objection Eff. October 15, 1992 due to lack of statutory authority;

Amended Eff. December 21, 1992;

RRC Objection Removed Eff. December 16, 1993;

Temporary Amendment Eff. October 1, 2001;

Amended Eff. August 1, 2002.