NOTE Effective utilization of instruments by the technical staff depends upon

Note effective utilization of instruments by the

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NOTE: Effective utilization of instruments by the technical staff depends upon the prompt availability of maintenance, repair, and service documentation (copies are acceptable). Laboratory personnel are responsible for the reliability and proper function of their instruments and must have access to this information. Off-site storage, such as with centralized medical maintenance or computer files, is not precluded if the inspector is satisfied that the records can be promptly retrieved. COMMENTARY: N/A ................................................................. Glassware ................................................................. CHEMISTRY AND TOXICOLOGY Page 66 of 124
College of American Pathologists Revised: 04/06/2006 CHM.23800 Phase II N/A YES NO Are glass volumetric flasks of certified accuracy (Class A, National Institute of Standards and Technology (NIST) Standard or equivalent) or if non-certified volumetric glassware is used, are all items checked for accuracy of calibration before initial use? COMMENTARY: N/A CHM.23900 Phase II N/A YES NO Are glass volumetric pipettes of certified accuracy (Class A); or are they checked by gravimetric, colorimetric, or some other verification procedure before initial use? NOTE: The following Table shows the American Society for Testing and Materials' calibration (accuracy) specifications for Class A volumetric pipettes: Nominal Capacity (mL) Variation (± mL) 0.5 - 2 0.006 3 - 7 0.01 8 – 10 0.02 15 - 30 0.03 40 - 50 0.05 100 0.08 Reconstitution of lyophilized calibrators, controls, or proficiency testing materials, or any other tasks requiring accurate volumetric measurement, must be performed only with measuring devices of Class A accuracy, or those for which accuracy has been defined and deemed acceptable for the intended use. COMMENTARY: N/A REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994 ;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994 ;12(9):16-17; 3) Perrier S, et al . Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) American Society for Testing and Materials. Standard specification for glass volumetric (transfer) pipets, designation E 969- 95. Philadelphia, PA: ASTM, 1995; 5) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 6) Connors M, Curtis R. Pipetting error: a real problem CHEMISTRY AND TOXICOLOGY Page 67 of 124
College of American Pathologists Revised: 04/06/2006 with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 7) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479. CHM.24000 Phase II N/A YES NO Are non-class A pipettes that are used for quantitative dispensing of material checked for accuracy and reproducibility at specified intervals, and results documented? NOTE: Such checks are most simply done gravimetrically. This consists of transferring a number of measured samples of water from the pipette to a balance. Each weight is recorded, the weights are converted to volumes, and then means (for accuracy), and SD/CV (for imprecision) are calculated.

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