What are the four areas the exam will include questions relating to?
These areas are critical for understanding quality assurance in laboratory settings.
Define calibration in the context of quality assurance.
The process in which the output signal from an instrument is adjusted to match a known input
Calibration ensures that the instrument provides accurate results.
How often may calibration be required?
The frequency of calibration depends on the specific instrument and its usage.
What is the purpose of quality control testing?
To evaluate the accuracy and precision of the equipment against a known standard
Regular quality control testing is essential for maintaining reliable laboratory results.
Define accuracy in measurement.
The extent to which the measurement of a known quantity results in a value approximating that quantity
Accuracy is assessed by calculating the mean of repeated measurements.
What is an example of accuracy in a spirometer measurement?
Multiple samples of air injected yield results of 2.9 L, 3.0 L, and 3.1 L, with a mean of 3.0 L
The spirometer is considered accurate if the mean approximates the known value.
Define precision in measurement.
The extent to which repeated measurements of the same quantity can be reproduced
Precision indicates the consistency of measurements, regardless of their accuracy.
What is an example of precision in a spirometer measurement?
Multiple samples of air injected yield results of 2.5 L, 2.5 L, and 2.5 L
The spirometer is considered precise if the results are similar.
What is linearity in the context of measurements?
A series of measurements over the clinically significant or physiologic range
Linearity ensures that the instrument’s response is consistent across a range of values.
How many data points are required to assess linearity?
A minimum of three data points
This is necessary to ensure accurate assessment of the instrument’s performance.
What can cause pneumotachometers to become alinear?
These factors can affect the accuracy and require frequent checks.
What is required to assure linearity and accuracy in volume spirometers?
A series of injected volumes distributed over the clinically significant range
This ensures that the instrument performs accurately across different flow rates.
What does repeatability refer to in quality assurance?
Variance within a test session
Example: Three successive pre-bronchodilation FVC efforts yield the same results.
What does reproducibility refer to in quality assurance?
Variance across test sessions
Example: FVC is measured for a patient with normal lung function on three successive days and yields different results.
What are biological controls in the context of PFT equipment?
Measured values from healthy people
Used to evaluate the function of PFT equipment.
What is a correction factor?
A number used to compensate for errors of measurements
Example: Correction factor = Expected volume / Measured volume.
Calculate the correction factor if a spirometer measures 3.075 L, 3.080 L, and 3.085 L with an expected volume of 3.0 L.
0.97
Mean of three trials = 3080 mL; Correction Factor = 3000 L / 3080 L.
What is the role of the Occupational Safety and Health Administration (OSHA)?
Develops policies to address hazards in the workplace
Includes managing hazardous chemicals and maintaining MSDS.
What must be maintained and available according to OSHA regulations?
Materials Safety Data Sheets (MSDS)
Required for hazardous chemicals or substances used in the lab.
What are the required procedures for handling patients with blood-borne pathogens?
These procedures are mandated by OSHA.
What is the role of the National Institute for Occupational Safety and Health (NIOSH)?
Conducting research and making recommendations for the prevention of work-related injury and illness
NIOSH is part of the CDC within the U.S. Department of Health and Human Services.
What standards does NIOSH establish?
Standards for spirometry testing for persons with occupational exposure
Ensures safety and accuracy in testing.
What does HHS stand for?
Health and Human Services
HHS supervises the Health Care Financing Administration (HCFA) which administers the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88).
What are the Laboratory Improvement Amendments of 1988 also known as?
CLIA-88
CLIA-88 includes regulations for operating pulmonary function and blood gas laboratories.