[36 Pa.B. 465]
[Continued from previous Web Page]
Subchapter C. GENERAL STANDARDS FOR ACCREDITATION Sec.
252.301. Laboratory supervisor. 252.302. Qualifications of the laboratory supervisor. 252.303. Grandfathering provisions for laboratory supervisors. 252.304. Personnel requirements. 252.305. Physical facilities. 252.306. Equipment, supplies and reference materials. 252.307. Methodology. § 252.301. Laboratory supervisor.
(a) Testing, analysis and reporting of data by an environmental laboratory shall be under the direct supervision of a laboratory supervisor.
(b) The laboratory supervisor shall certify that each test or analysis is accurate and valid and the test or analysis was performed in accordance with all conditions of accreditation. A laboratory supervisor may certify a test or analysis by signing the final laboratory report. A laboratory may use other mechanisms to certify a test or analysis, provided the mechanism is documented in the laboratory quality manual.
(c) The laboratory supervisor shall ensure that the records required by this chapter are maintained.
(d) The Department may disqualify a laboratory supervisor who is responsible for the submission of inaccurate test or analysis results.
(e) The Department will disqualify a laboratory supervisor convicted of any crime or offense related to violations of State or Federal laws or regulations related to the provision of environmental laboratory services or reimbursement for the services.
(f) An environmental laboratory may appoint one or more laboratory supervisors for the appropriate fields of accreditation for which they are seeking accreditation.
(g) An environmental laboratory shall designate another staff member meeting the qualifications of a laboratory supervisor to temporarily perform this function when a laboratory supervisor is absent for a period of time exceeding 16 consecutive calendar days. If this absence exceeds 30 consecutive calendar days, the environmental laboratory shall notify the Department in writing under § 252.708 (relating to reporting and notification requirements).
(h) An individual may not be the laboratory supervisor of more than one environmental laboratory without authorization from the Department. Circumstances to be considered in the decision to grant the authorization will include at least the following:
(1) The extent to which operating hours of the laboratories to be supervised overlap.
(2) The adequacy of supervision in each laboratory.
§ 252.302. Qualifications of the laboratory supervisor.
(a) A laboratory supervisor of an environmental laboratory engaged in chemical analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative inorganic and organic fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(b) A laboratory supervisor of an environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have the following qualifications:
(1) At least an earned associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering, or 2 years of equivalent and successful college education.
(2) At least 16-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(c) A laboratory supervisor of an environmental laboratory engaged in microbiological or biological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 16-college semester credit hours in general microbiology and biology.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative microbiological or biological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. A master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(d) A laboratory supervisor of an environmental laboratory engaged in microbiological analysis limited to fecal coliform, total coliform and heterotropic bacteria shall have the following qualifications:
(1) At least an associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) A minimum of 4-college semester credit hours in general microbiology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in general microbiology, may be substituted for the associate's degree.
(4) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(e) A laboratory supervisor of an environmental laboratory engaged in radiological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative radiological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(f) A laboratory supervisor of an environmental laboratory engaged in microscopic examination of asbestos or airborne fibers shall have the following qualifications:
(1) For procedures requiring the use of a transmission electron microscope, a bachelor's degree, successful completion of formal course work in the use of the instrument, and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(2) For procedures requiring the use of a polarized light microscope, an associate's degree or 2 years of college study, successful completion of formal coursework in polarized light microscopy, and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(3) For procedures requiring the use of a phase contrast microscope, an associate's degree or 1 year of college study, documentation of successful completion of formal coursework in phase contrast microscopy, and 1 year of experience, under supervision, in the use of the instrument.
(g) Notwithstanding any other provision of this section, a laboratory supervisor of an environmental laboratory limited to the basic nonpotable water category or the basic drinking water category, shall have the following qualifications:
(1) At least 16-college semester credit hours in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(h) Notwithstanding any other provision of this section, an employee of a drinking water, wastewater or industrial waste treatment facility meeting the following requirements will be deemed qualified as a laboratory supervisor of an environmental laboratory:
(1) The employee holds a valid treatment plant operator's certificate under the Water and Wastewater Systems Operators' Certification Act (63 P. S. §§ 1001--1015.1) in the appropriate water or wastewater subclassification for the facility.
(2) The employee holds a valid certificate under the Water and Wastewater Systems Operators' Certification Act for laboratory supervisor in the appropriate water or wastewater subclassification.
(3) Until 12 months after a certificate under the Water and Wastewater Systems Operators' Certification Act for laboratory supervisor in the appropriate water or wastewater subclassification becomes available from the Department, 2 years of experience performing testing or analysis of environmental samples using the methods and procedures currently in use by the environmental laboratory may be substituted for a laboratory supervisory certificate.
(i) Approval as a laboratory supervisor under subsection (h) will be limited to the fields of accreditation required by the scope of that facility's regulatory permit.
§ 252.303. Grandfathering provisions for laboratory supervisors.
(a) A person who does not meet the education credential requirements for a laboratory supervisor but possesses the requisite years of experience required by § 252.302 (relating to qualifications of the laboratory supervisor) shall qualify as laboratory supervisor subject to the following conditions:
(1) The person shall be a laboratory supervisor of the environmental laboratory on January 28, 2006.
(2) The person shall have been a laboratory supervisor of the environmental laboratory for at least 12 months for the fields of accreditation for which the environmental laboratory is applying.
(b) A person will be approved as a laboratory supervisor only for those fields of accreditation for which the person has been laboratory supervisor of the environmental laboratory for at least 12 months.
(c) The Department may approve a person, qualified as a laboratory supervisor under this section, for additional fields of accreditation if the person has the appropriate knowledge, skills and abilities to perform and supervise the testing or analyses on environmental samples for the requested fields of accreditation.
(d) Qualification as a laboratory supervisor under this subsection may not be transferred to another laboratory.
§ 252.304. Personnel requirements.
(a) General requirements for technical staff.
(1) An environmental laboratory shall have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions.
(2) Each member of the environmental laboratory technical staff shall be responsible for complying with quality assurance and quality control requirements that pertain to their organizational or technical function.
(3) Each environmental laboratory technical staff member shall have a combination of experience and education to adequately demonstrate a specific knowledge of the member's particular function and a general knowledge of laboratory operations, test methods, quality assurance and quality control procedures and records management.
(b) Laboratory management responsibilities. The environmental laboratory management shall be responsible for:
(1) Defining the minimal level of qualification, experience and skills necessary for all positions or work cells in the environmental laboratory.
(2) Ensuring and documenting that the environmental laboratory technical staff members or work cells have demonstrated capability in the activities for which they are responsible.
(3) Ensuring and documenting that the training and competency of each member of the environmental laboratory technical staff is kept up to date by maintaining records demonstrating the following:
(i) That each employee has read, understood and is using the latest version of the environmental laboratory's quality manual that relates to each employee's job responsibilities.
(ii) That each employee has read, understood and is using the latest versions of the environmental laboratory's standard operating procedures that relate to each employee's job responsibilities.
(iii) Participation in training courses or workshops on specific equipment, analytical techniques or laboratory procedures that relate to each employee's job responsibilities.
(iv) Participation in training courses in ethical and legal responsibilities including the potential liabilities for improper, unethical or illegal actions.
(v) That each employee has read, understood and acknowledged his personal ethical and legal responsibilities including the potential punishments and penalties for improper, unethical or illegal actions.
(vi) An initial demonstration of capability for each method that relates to the employee's job responsibilities.
(vii) A demonstration of continued proficiency by at least one of the following every 12 months for each method that relates to the employee's job responsibilities:
(A) Another initial demonstration of capability.
(B) Acceptable performance of blind performance samples (single blind to the analyst).
(C) Successful analysis of blind proficiency test samples on a similar test method using the same technology (for example--GC/MS volatiles by purge and trap for EPA Methods 524.2, 624 or 5030/8260 would require documentation for only one of the test methods.)
(D) At least four consecutive laboratory control samples with acceptable levels of precision and accuracy.
(E) Analysis of at least ten authentic samples with results statistically indistinguishable from those obtained by another trained analyst. The samples must include samples free of the analyte of interest and samples containing the analyte of interest at measurable concentrations.
(4) Supervising personnel employed by the laboratory.
(5) Establishing and implementing procedures and processes for permitting departures from documented policies and procedures.
(6) Ensuring that sample acceptance criteria are verified and that samples are logged into the sample tracking system and properly labeled and stored.
(7) Developing a proactive program for prevention and detection of improper, unethical, or illegal actions. Components of this program may include the following:
(i) Internal proficiency testing (single and double blind).
(ii) Postanalysis electronic data and magnetic tape audits or reviews.
(iii) Separate standard operating procedures identifying appropriate and inappropriate laboratory and instrument manipulation practices.
(c) An environmental laboratory shall maintain records on initial demonstrations of capability, demonstrations of continued proficiency, proficiency test samples for each laboratory method and the qualifications, training, skills and experience of the laboratory technical staff members.
§ 252.305. Physical facilities.
(a) An environmental laboratory shall have accommodations, work areas, energy sources, lighting, heating and ventilation necessary to assure proper performance of tests and analyses.
(b) The environment in which testing or analysis of environmental samples is undertaken may not adversely affect the results of the testing or analysis or the required accuracy of measurement.
(c) An environmental laboratory shall document its monitoring and control of environmental conditions where monitoring or control of environmental conditions is specified in a method or by regulation.
(d) There must be effective separation between neighboring work areas and between work areas and nonwork areas when the activities performed in the different areas are incompatible.
(e) Adequate measures shall be taken to ensure that contamination does not adversely affect data quality.
§ 252.306. Equipment, supplies and reference materials.
(a) An environmental laboratory shall be furnished with all items of equipment, including reference materials, required for the correct performance of tests or analyses for which accreditation is sought.
(b) An environmental laboratory shall maintain records of each item of equipment significant to the testing or analysis performed. These records must include documentation on the following:
(1) The name of the item of equipment.
(2) The manufacturer's name, type identification, and serial number or other unique identification.
(3) The date received and date placed in service (if available).
(4) The current location, when appropriate.
(5) If available, condition when received (for example, new, used or reconditioned).
(6) A copy of the manufacturer's instructions, where available.
(7) The dates and results of calibrations or verifications.
(8) The manufacturer's instructions, if available, or reference their location.
(9) The details of maintenance performed.
(10) A history of damage, malfunction, modification or repair.
(c) An environmental laboratory shall assure that the test instruments consistently operate within the specifications required of the application for which the equipment is used.
(d) Equipment shall be properly maintained, inspected and cleaned.
(e) Any item of equipment that has been subjected to overloading, mishandling, gives suspect results or has otherwise been shown to be defective, shall be taken out of service and clearly identified until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous testing or analysis.
(f) The following pieces of equipment shall be maintained according to this subsection.
(1) Certified NIST-reference thermometer.
(i) A certified NIST-reference thermometer must have appropriate graduations and a range that spans the requirements of the method.
(ii) The certified NIST-reference thermometer shall be recalibrated at least once every 5 years at the temperatures of use.
(iii) An environmental laboratory shall retain a certificate documenting traceability of the calibration to NIST standards.
(2) Working thermometers.
(i) Working thermometers must have appropriate graduations and a range that spans the requirements of the method.
(ii) Working thermometers may be glass, dial or electronic and shall be calibrated against a certified NIST-reference thermometer as follows:
(A) Glass and electronic thermometers and continuous recording devices shall be calibrated every 12 months at the temperature used.
(B) Dial thermometers shall be calibrated every 3 months at the temperature used. Dial thermometers that cannot be calibrated may not be used.
(C) An environmental laboratory shall maintain records in a laboratory notebook for each working thermometer that documents the date of calibration, NIST reference thermometer identification, working thermometer identification, reference thermometer temperature reading, working thermometer temperature reading, correction factor and the initials of the individual conducting the calibration.
(D) Working thermometers shall be uniquely identified and labeled with the date of calibration and correction factor.
(iii) The fluid column in glass thermometers may not be separated.
(iv) A working thermometer that differs by more than 1.0°C from the reference thermometer may not be used.
(3) ASTM type 1, 2 or 3 (Class S or S-1) certified reference weights.
(i) The mass of ASTM type 1, 2 or 3 (Class S or S-1) certified reference weights shall be recertified at least once every 5 years.
(ii) An environmental laboratory shall retain a certificate documenting traceability of the calibration to ASTM standards.
(4) Analytical or pan balances.
(i) Analytical or pan balances must provide sufficient accuracy and sensitivity for the weighing needs of the method.
(ii) An environmental laboratory shall verify the calibration of a balance daily or before each use, whichever is less frequent.
(iii) A reference weight that is damaged or corroded may not be used for calibration of balances.
(iv) Balance calibration shall be verified using a minimum of three ASTM type 1, 2 or 3 (Class S or S-1) certified reference weights that bracket the effective range of the balance's use.
(v) An environmental laboratory shall maintain records in a laboratory notebook of balance calibrations that document the balance identification, date of calibration verification, reference weights used and initials of the individual performing the calibration. Correction factors shall be documented and used.
(vi) A qualified person shall service and calibrate analytical balances at least once per year.
(vii) Records of annual service shall be maintained and the service date shall be recorded on the balance.
(5) pH meter.
(i) A pH meter must be equipped with an appropriate electrode and have scale graduations and accuracy appropriate to the method.
(ii) An environmental laboratory shall utilize either a thermometer or a temperature sensor for automatic compensation to make corrections for pH measurements.
(iii) The pH meter shall be standardized daily or before each use, whichever is less frequent, by one of the following:
(A) With at least three standard buffers which are at least three pH units apart and which bracket the expected pH range of the samples.
(B) Use a pH 7.0 and either a pH 4.0 or 10.0 standard buffer; whichever range covers the desired pH range of use.
(iv) Aliquots of standard buffers may not be used for longer than 1 analysis day.
(v) Records of pH meter standardization shall be maintained in a laboratory notebook that documents the date of standardization, calibration buffers used and initials of the individual conducting the standardization.
(6) Conductivity meter.
(i) A conductivity meter must have a probe of sufficient sensitivity for the method. The scale must have readability in appropriate units, for example micromhos or microsiemens per centimeter.
(ii) An in-line conductivity meter that cannot be calibrated may not be used.
(iii) An environmental laboratory shall calibrate the conductivity meter daily or before each use whichever is less frequent, by one of the following:
(A) With certified and traceable standard solutions within the range of interest.
(B) By determining the cell constant utilizing the method described in currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005.)
(iv) Records of conductivity meter calibrations shall be maintained in a laboratory notebook that documents the date of calibration, standards used, results of calibration or cell constant determined and the initials of the individual conducting the calibration.
(7) Refrigeration equipment and freezers.
(i) An environmental laboratory shall maintain one thermometer immersed in liquid (except electronic thermometers) to the appropriate immersion line for each refrigerator or freezer. The thermometer must be graduated in increments no larger than 1°C.
(ii) Calibration-corrected temperatures for each refrigerator and freezer shall be recorded once a day for each day in use for all laboratory activities. The date, refrigerator or freezer identification, calibration corrected temperature and initial of responsible individual shall be recorded.
(iii) Samples and standards shall be stored in separate refrigerators where the potential for cross-contamination exists.
(iv) Samples which require thermal preservation shall be stored at a temperature which is + 2°C of the specified preservation temperature unless method specific criteria exist. For samples with a storage temperature of 4°C, storage at a temperature of 0.5°C to 6°C is acceptable.
(v) Freezer temperatures must be less than 0°C.
(8) Incubators, water baths and heating blocks.
(i) An environmental laboratory shall control and monitor the temperature of incubators, water baths and heating blocks in accordance with the method or as specified by regulations.
(ii) An environmental laboratory shall maintain a minimum of one thermometer per incubator, water bath or heating block immersed in liquid (except electronic thermometers) to the appropriate immersion line. When used as an incubation unit for microbiology, a minimum of one working thermometer shall be on the top and bottom shelf of the use area in each incubator.
(iii) When used as an incubation unit for microbiology, a water bath must be equipped with a gable cover and a pump or paddles to circulate the water.
(iv) Calibration-corrected temperatures for each incubator, water bath or heating block shall be recorded once a day for each day in use for all laboratory activities. When used as an incubation unit for microbiology, the calibration-corrected temperature shall be recorded at least twice per day in use with the readings separated by at least 4 hours. The incubator, water bath or heating block identification, date, time, calibration corrected temperature and the initials of the responsible individual shall be recorded.
(9) Volumetric dispensing devices. Except for Class A glassware, mechanical volumetric dispensing devices including burettes, autopipetors and dilutors, must be of sufficient sensitivity for the application. Delivery volumes of mechanical volumetric dispensing devices shall be checked using a gravimetric method at least once every 3 months.
(10) Graduated sample containers. When graduation marks on clear glass or plastic funnels or sample bottles are used to measure sample volume, an environmental laboratory shall verify and document the accuracy of the volume of each lot or at least once per year, whichever is more frequent.
(11) Spectrophotometer or colorimeter. A spectro- phometer or colorimeter must be calibrated according to the manufacturer's specifications or test methods. An environmental laboratory shall maintain records of the calibrations.
(g) An environmental laboratory shall maintain records for all reference materials, reagents and support services utilized by the laboratory for testing or analysis.
(h) Reference materials and reagents used for environmental testing must meet the following minimum requirements:
(1) Analytical reagent grade chemicals or equivalent are acceptable, unless a method specifies other reagent purity grade requirements.
(2) Reagent and standard solutions shall be checked regularly for signs of decomposition, evaporation, and expiration. An environmental laboratory shall maintain standard and reagent preparation logs for all stock and working standard solutions in a laboratory notebook. Standards and reagent preparation logs must contain identification of the compound, concentration, date prepared, initials of the individual preparing the solution and expiration date.
(3) Reagent and standard solution containers shall be labeled with identification of the compound, concentration, date prepared, initials of the individual who prepared the solution and expiration date.
(4) Purchased chemicals, solutions and standards shall be labeled with date of receipt and the date when the container is opened. Purchased chemicals, solutions and standards without an expiration date on the original container shall be discarded after 10 years from the date of receipt.
(5) When reagents are removed from a container, the amount removed shall be used entirely or the unused portion discarded.
(6) Compressed gases must be of commercial grade, unless a method specifies other requirements.
(i) Plastic and glassware shall be cleaned to meet the sensitivity of the test method. Any cleaning and storage procedures that are not specified by the method shall be documented in a laboratory standard operating procedure.
§ 252.307. Methodology.
(a) An environmental laboratory shall follow the requirements for testing or analysis, sample collection, sample preservation and holding times specified in this section.
(b) An environmental laboratory shall select an analytical method for a specific test or analysis that meets the following criteria:
(1) The method is appropriate for the analyte and sample matrix.
(2) The method is required by, or considered appropriate for use under, applicable State or Federal regulations, a permit, an order, or is an approved alternate method under subsection (c).
(3) The method enables the laboratory to quantitate at required levels.
(c) When a method meeting the requirements of subsection (b) is not available, an environmental laboratory may apply to the Department to use alternate or experimental procedures.
(1) The Department will approve the use of alternate methodologies if the EPA has approved their use. An environmental laboratory shall submit a copy of the EPA's written approval for the use of the alternate method to the Department.
(2) The Department may allow alternate methods that use new or innovative technologies on a case-by-case basis.
(3) An environmental laboratory shall submit a request for use of new or innovative technology in writing to the Department. The request must include the reasons for proposing the method and the potential scope of use for the method.
(4) The Department will establish criteria for validating the method that are based upon the analyte to be tested.
(5) Upon receipt of the method validation data that meets the established criteria, the Department will approve or deny the request within 90 days and inform the laboratory of the basis of its decision in writing. The evaluation for approval will include consideration of the demonstrated need for the new or innovative technology, reasons for using the method, performance of the method, method validation data and applicability of the method to the matrix.
(d) An environmental laboratory shall develop and maintain written standard operating procedures for all fields of accreditation.
(1) The environmental laboratory's standard operating procedures must accurately reflect all aspects of the testing or analysis for the fields of accreditation, including the following:
(i) Identification of the method.
(ii) Effective date.
(iii) Scope, including applicable matrix or matrices.
(iv) Equipment and supplies.
(v) Reagents and standards.
(vi) Quality control.
(vii) Calibration and standardization.
(viii) Analytical procedure.
(ix) Calculations.
(x) Corrective actions or contingencies for handling out-of-control or unacceptable quality control data.
(xi) Reporting of results.
(2) The standard operating procedures may consist of copies of published or referenced test methods or standard operating procedures that have been written by the environmental laboratory. When modifications to the published or referenced method have been made by the laboratory or when the published or referenced method is ambiguous or provides insufficient detail, the changes or clarifications shall be clearly described.
(e) An environmental laboratory shall make copies of the standard operating procedures, the promulgated method, Department regulations and Department guidance pertaining to testing or analysis of environmental samples available to the technical staff.
(f) When an environmental laboratory collects a sample to be analyzed, the sample collection method required by applicable State and Federal laws, regulations or permit conditions shall be followed.
(g) An environmental laboratory shall follow the sample container, preservation procedures and holding times required by State and Federal regulations. If the sample container, preservation procedures and holding times are not required by State or Federal regulations, an environmental laboratory shall follow the sample container, sample preservation procedures and holding time established in the method.
(h) The range of quantitation and detection limit shall be determined for each analyte reported by an environmental laboratory in accordance with a method specified by the Department.
(i) When a method specifies a validation procedure, the validation procedure shall be completed before environmental samples may be analyzed and reported. The results of this validation procedure shall be documented and kept on file for the duration of use of the method and for at least 5 years after the method is no longer in use.
(j) The initial demonstration of capability requirements are as follows:
(1) Prior to the use of any method, an initial demonstration of capability is required.
(2) An initial demonstration of capability shall be completed each time there is a change in instrument type, personnel, or method.
(3) An initial demonstration of capability must include all sample preparation and analytical steps contained in the method.
(4) If the method or State or Federal regulations specify a procedure for the initial demonstration of capability, that procedure shall be followed, otherwise, an initial demonstration of capability shall be performed as follows:
(i) The analyte shall be diluted in a volume of clean matrix sufficient to prepare four aliquots at the concentration specified in the method. If the method does not specify a concentration, the concentration must be approximately ten times the detection limit.
(ii) At least four aliquots of the quality control sample must be prepared and analyzed according to the method.
(iii) Using all of the results, calculate the mean recovery and the standard deviation of the mean recovery for the population sample in the same units used to report environmental samples. When it is not possible to determine mean and standard deviation, such as for presence-absence and logarithmic values, the environmental laboratory shall assess method performance using criteria from the method or other established and documented criteria.
(iv) Compare the information from subparagraph (iii) to the corresponding acceptance criteria for precision and accuracy in the method. To be considered acceptable, an initial demonstration of capability must meet all acceptance criteria.
(5) When a method has been in use by an environmental laboratory prior to January 1, 2005, and there have been no changes in instrument type, personnel or method, an initial demonstration of capability is not required. An environmental laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.
(6) The laboratory shall retain all data necessary to reproduce the initial demonstration of capability.
(7) The work cell as a unit shall meet the requirements of this paragraph.
(i) When a member of a work cell changes, the new employee shall work with an experienced analyst in the work cell.
(ii) When a member of a work cell changes, the new work cell shall demonstrate capability by means of acceptable quality control performance checks on four consecutive batches. The acceptable performance shall be documented. If any quality control performance check within the four consecutive batches following the change in personnel fails to meet acceptance criteria, an initial demonstration of capability shall be completed.
(iii) If the entire work cell is changed, an initial demonstration of capability shall be completed.
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
