ATS Pulmonary Function Laboratory Manual

chapter  5

1.2. Accuracy should be checked by having the device revalidated by the manufacturer at a frequency recommended by the manufacturer, or yearly when no specific recommendation is provided. 1.3. When available, the same calibration device should be used regularly on a large number of instru- ments so that problems with the calibration device can be separated from those of the instrument. Record Keeping and Logs 1. Problem or Troubleshooting Log: a log used to document problems, repairs, and revalidation. It should include: 1.1. Date 1.2. Problem 1.3. Remedial action 1.4. Revalidation data 1.5. Name of individual solving problem. 2. Preventive Maintenance (PM) List/Log: a log used to list all equipment and document PM. It should include: 2.1. List of instrumentation to be maintained and schedule of when maintenance is to be done 2.2. Date of PM 2.3. Problems identified 2.4. Name of individual performing PM. 3. Calibration Log: a log used to document calibration (verification) information. It should include: 3.1. Date 3.2. Barometric pressure and ambient or device temperature 3.3. Humidity, if applicable 3.4. Section for calibration/validation of calibrators, scales, thermometers, etc. 3.5. Inspiratory and/or expiratory volume calibration check (for spirometers or volume-measuring devices) 3.6. Positive and negative pressures (for pressure-measuring devices) 3.7. Gas analyzer’s high and low values 3.8. Acceptability range and whether instrument met acceptance criteria 3.9. Name of individual performing calibration. 4. Quality Control Log: a log used to document the quality control performed by the laboratory. It should include: 4.1. Date and time of quality control procedure 4.2. Quality control method (e.g., known-volume syringe and biologic standard) 4.3. Name of test and/or instrument or method 4.4. Acceptability range 4.5. Control chart 4.6. Name of individual performing quality control 4.7. Precision verification data forms 4.8. Record of calibration of calibrators. 5. Storage of Logs 5.1. Computer storage of data should have a good system for back-up and be easily retrievable. 5.2. Installation manual and preventive maintenance log should be kept for the life of the instrument. 5.3. Problem or troubleshooting log should be kept for at least 3 years. 5.4. Calibration and quality control logs should be kept for at least 2 years or longer when local law has specific recommendations.

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