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) The Department will consider the laboratory supervisor of an environmental laboratory as the individual listed on the laboratory’s application for accreditation for which the Department has reviewed and approved the individual’s qualifications.
(b) Testing, analysis and reporting of data by an environmental laboratory shall be under the direct supervision of a laboratory supervisor.
(c) 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.
(d) The laboratory supervisor shall ensure that the records required by this chapter are maintained.
(e) The Department may disqualify a laboratory supervisor who is responsible for the submission of inaccurate test or analysis results.
(f) 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.
(g) An environmental laboratory may appoint one or more laboratory supervisors for the appropriate fields of accreditation for which they are seeking accreditation.
(h) An environmental laboratory shall designate another staff member meeting the qualifications of a laboratory supervisor and who is approved by the Department as described in subsection (a) to temporarily perform this function when a laboratory supervisor is absent for a period of time exceeding 21 consecutive calendar days. If this temporary absence exceeds 30 consecutive calendar days, the environmental laboratory shall notify the Department in writing under § 252.708 (relating to reporting and notification requirements).
(i) 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.
Authority The provisions of this § 252.301 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.301 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348794) to (348795).
§ 252.302. Qualifications of the laboratory supervisor.
(a) A laboratory supervisor of an environmental laboratory engaged in chemical analysis of organics or metals, or both, 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 engaged in inorganic nonmetals chemical 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 1 year 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 biology. At least 4 of the 16-college semester credit hours must be in microbiology.
(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, E. coli and heterotrophic 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 microbiology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in microbiology may be substituted for the associate’s degree.
(4) At least 1 year 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 or health physics.
(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 1 year 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) At least 1 year of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or maintain accreditation.
(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.
(j) A laboratory supervisor of an environmental laboratory engaged in whole effluent toxicity analysis 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 biology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in biology 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.
(k) College semester credit hours shall be obtained from an accredited college or university recognized by the United States Department of Education.
(l) Foreign transcripts must be translated into English and evaluated for United States semester credit hour equivalency by a credential evaluation agency accredited by the National Association of Credentials Evaluation Services or a Department of Education approved agency.
(m) If a method, regulation or program requires more stringent qualifications for education or experience, or both, the laboratory shall meet the more stringent requirement.
Authority The provisions of this § 252.302 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.302 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348795) to (348796) and (352727) to (352728).
Cross References This section cited in 25 Pa. Code § 252.303 (relating to grandfathering provisions for laboratory supervisors); and 25 Pa. Code § 302.1006 (relating to laboratory supervisor certification).
§ 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.
Cross References This section cited in 25 Pa. Code § 302.1006 (relating to laboratory supervisor certification).
§ 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 the member’s 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.
(4) If a method, regulation or program requires more stringent qualifications for education or experience, or both, the laboratory technical staff shall meet the more stringent requirement.
(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. This documentation must include:
(i) An identification of the analysts involved in the preparation or analysis, or both.
(ii) The sample matrix.
(iii) The analyte, class of analyte or measured parameter.
(iv) An identification of the test method performed.
(v) An identification of the laboratory-specific standard operating procedure used for analysis, including revision number and effective date.
(vi) The dates of preparation or analysis, or both.
(vii) The summary of analyses, including results.
(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 has been performed. The initial demonstration of capability requirements are as follows:
(A) An initial demonstration of capability is required prior to the use of any method.
(B) An initial demonstration of capability shall be completed each time there is a change in instrument type, personnel or method.
(C) An initial demonstration of capability must include all sample preparation and analytical steps contained in the method.
(D) 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 in the lower half of the calibration range or at or below the maximum contaminant level for Safe Drinking Water Act compliance testing, whichever is lower.
(II) At least four aliquots of the quality control sample shall be prepared and analyzed consecutively according to the method. The preparation or analysis, or both, may occur on a single day or over the course of multiple days.
(III) Using all of the results, calculate the individual recovery, 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 subclause (III) to the corresponding acceptance criteria for precision and accuracy in the method. If the method or regulation does not specify acceptance limits, the % Relative Standard Deviation must be less than 20%. To be considered acceptable, an initial demonstration of capability must meet all acceptance criteria.
(E) 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, the environmental laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.
(F) The laboratory shall retain all data necessary to reproduce the initial demonstration of capability.
(G) The work cell as a unit shall meet the following requirements:
(I) 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.
(II) If the entire work cell is changed, an initial demonstration of capability shall be completed.
(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 as required by the initial demonstration of capability described in subparagraph (vi).
(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.
Authority The provisions of this § 252.304 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.304 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (352728) and (348799) to (348802).
Cross References This section cited in 25 Pa. Code § 252.401 (relating to basic requirements).
§ 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, when 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 and all equipment, supplies and reference materials consistently operate within and meet the specifications required of the application for which it 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, liquid filled thermometers shall be calibrated every 12 months at the temperature used.
(B) Dial and electronic thermometers shall be calibrated every 3 months at the temperature used. Electronic thermometers accompanied by a valid NIST traceable certificate of acceptance may be used for 12 months from the date of receipt before recalibration.
(C) An environmental laboratory shall maintain records in a laboratory notebook for each working thermometer that document 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 2.0°C from the reference thermometer may not be used.
(3) ASTM class 1, 2 or 3 (Class S or S-1), or better certified reference weights.
(i) The mass of ASTM class 1, 2 or 3 (Class S or S-1), or better 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 class 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 and verifications that document the balance identification, date of calibration, date of verification, reference weights used, observed measurement and initials of the individual performing the calibration verification.
(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 graduators 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 calibrated 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.
(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 calibration shall be maintained in a laboratory notebook that document the date of calibration, calibration buffers used, results of the calibration, results of the calibration verification and initials of the individual conducting the calibration.
(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, 800 I Street, NW, Washington, D.C. 20001.)
(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 working 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, heating blocks and ovens.
(i) An environmental laboratory shall control and monitor the temperature of incubators, water baths, heating blocks and ovens 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, heating block or oven immersed in liquid or sand for ovens (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, heating block or oven shall be recorded once a day for each working 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 each day the incubator is in use with the readings separated by at least 4 hours. The incubator, water bath, heating block or oven identification, date, time, calibration corrected temperature and the initials of the responsible individual shall be recorded.
(9) Volumetric dispensing devices.
(i) Except for Class A glassware and glass microliter syringes, volumetric dispensing devices, including graduated cylinders, pipettes and burettes, must be of sufficient sensitivity for the application and the environmental laboratory shall verify and document the accuracy of the volume of use for each lot or at least once per year, whichever is more frequent. Delivery volumes of mechanical volumetric dispensing devices such as mechanical pipettes, autopipetors and dilutors shall be checked at least once every 3 months.
(ii) Verification will be considered acceptable if the accuracy of the volumetric dispensing device is within 2.5% of expected values. Volumetric dispensing devices that do not meet this criterion may not be used.
(10) Graduated sample containers.
(i) Except for Class A glassware, when graduation marks on filter funnels, sample bottles or labware are used to measure sample volume or prepare standards or reagents, an environmental laboratory shall verify and document the accuracy of the volume of use for each lot or at least once per year, whichever is more frequent.
(ii) Verification will be considered acceptable if the accuracy of the graduated sample container is within 2.5% of expected values. Graduated sample containers that do not meet this criterion may not be used to measure sample volumes.
(g) An environmental laboratory shall maintain records for all reference materials, reagents, laboratory supplies that are essential to obtain analytical results and support services utilized by the laboratory for testing or analysis.
(h) Reference materials, reagents, media and laboratory supplies that are essential to obtain analytical results (such as filters, solid-phase extraction disks/cartridges, presterilized filtration units, certified precleaned laboratory supplies, disposable volumetric equipment, prepreserved sample containers) 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) Standard, reagent, media and laboratory supply receipt records shall be maintained. These records must include vendor, lot number, amount received, date of receipt, expiration date and certificates of analysis or purity, if available.
(3) Purchased chemicals, solutions, standards, media and laboratory supplies shall be labeled with date of receipt, expiration date 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.
(4) An environmental laboratory shall maintain records of standard, reagent and media preparation. Standard, media and reagent preparation records must contain identification of the compound, manufacturer, lot number, concentration, amount prepared, date prepared, final pH if used for microbiology testing, initials of the individual preparing the solution and expiration date.
(5) Reagent, media and standard solution containers shall be labeled with identification of the compound, traceability to the preparation record, such as unique identifier, and expiration date.
(6) Standards, reagents and media may not be used past the date of expiration. Expired reagents, standards and media shall be segregated from unexpired laboratory materials in a manner that ensures they are not used for the testing of environmental samples.
(7) Reagents, standards and media shall be checked regularly for signs of decomposition and evaporation. Reagents, standards and media exhibiting signs of decomposition or evaporation shall be discarded.
(8) When reagents, standards and media are removed from a container, the amount removed shall be used entirely or the unused portion discarded.
(9) 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.
(j) Except for circulating water baths, the laboratory shall perform temperature distribution studies for incubators that are used as incubation units for microbiology. The laboratory shall perform a temperature distribution study for each incubator prior to first use, after repair and every 3 years by the following procedure:
(1) The laboratory shall develop a procedure to determine the temperature distribution and fluctuations within an incubator. The laboratory shall take into account the size of the incubator (height, width and depth), number of shelves and type of incubator when developing the procedure to perform the temperature distribution study.
(2) At a minimum, the laboratory shall monitor and record the temperature of each shelf.
(3) Incubators that do not maintain constant temperatures within the acceptable temperature range for the application may not be used. The laboratory may establish procedures to limit incubator use to specific shelves or areas of the incubator that can be verified to maintain acceptable temperature fluctuations.
Authority The provisions of this § 252.306 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.306 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348802) to (348807).
Cross References This section cited in 25 Pa. Code § 252.402 (relating to essential quality control requirements—chemistry); 25 Pa. Code § 252.404 (relating to essential quality control requirements—microbiology); and 25 Pa. Code § 252.405 (relating to essential quality control requirement—radiochemistry).
§ 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, quantitation range, and for drinking water testing MCLs or action levels as appropriate.
(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) An environmental laboratory shall maintain instructions for sample collection and preservation that meet the requirements of subsections (f) and (g).
(1) The environmental laboratory’s instructions must accurately reflect all aspects of the sample collection and preservation requirements for the particular analyses, including the following:
(i) Container type, size and number of containers or bottles.
(ii) Sample collection method, amount of sample required and explanation of other specific requirements for sample collection such as ‘‘zero headspace’’ and ‘‘first draw.’’
(iii) Chemical preservation, including type of preservation and the procedure used to preserve the sample.
(iv) Thermal preservation, including the temperature requirements and procedure used to preserve the sample.
(v) Field blank requirements.
(vi) Holding time.
(2) The environmental laboratory shall make the sample collection and preservation instructions available to all laboratory sample collection personnel and to customers and clients that collect samples.
Authority The provisions of this § 252.307 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.307 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348807) to (348809).
Cross References This section cited in 25 Pa. Code § 252.5 (relating to NELAP equivalency); 25 Pa. Code § 252.402 (relating to essential quality control requirements—chemistry); 25 Pa. Code § 252.403 (relating to essential quality control requirements—toxicity testing); 25 Pa. Code § 252.404 (relating to essential quality control requirement—microbiology); and 25 Pa. Code § 252.405 (relating to essential quality control requirement—radiochemistry).
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