Current through Register Vol. 54, No. 45, November 9, 2024
Section 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.The provisions of this §252.306 amended April 9, 2010, effective 4/10/2010, 40 Pa.B. 1898; amended July 28, 2017, effective 7/29/2017, 47 Pa.B. 4085.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).
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).