Quality Control Quality Control Spirometry & Lung Spirometry & Lung Volumes Volumes Gregg L. Ruppel, MEd, RRT, RPFT, Gregg L. Ruppel, MEd, RRT, RPFT, FAARC FAARC Adjunct Professor, Pulmonary, Adjunct Professor, Pulmonary, Critical Care Critical Care & Sleep Medicine & Sleep Medicine Director, Pulmonary Function Director, Pulmonary Function Laboratory Laboratory St. Louis University Hospital St. Louis University Hospital
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Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,
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Gregg L. Ruppel, MEd, RRT, RPFT, FAARCGregg L. Ruppel, MEd, RRT, RPFT, FAARC
Adjunct Professor, Pulmonary, Critical CareAdjunct Professor, Pulmonary, Critical Care
& Sleep Medicine& Sleep Medicine
Director, Pulmonary Function LaboratoryDirector, Pulmonary Function Laboratory
St. Louis University HospitalSt. Louis University Hospital
What Quality Control IsWhat Quality Control Is
NOT !!
What Quality Control IsWhat Quality Control Is
“Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA).”
IT DepartmentJohns Hopkins University
Calibration vs. Quality ControlCalibration vs. Quality Control
Calibration Calibration adjustsadjusts the output of an the output of an instrument (spirometer, gas analyzer) to instrument (spirometer, gas analyzer) to match a known inputmatch a known input
Quality control Quality control teststests an instrument to an instrument to verifyverify that the output is accurate and/or precisethat the output is accurate and/or precise
Spirometry QualitySpirometry Quality
SpirometryAcceptabilityRepeatability
Methods
Patients
Spirometer
Technologist
open vs.closed
patient coaching
meets ATS/ERSrecommendationscalibration
software
environmentalfactors Q/C
age
disease state
language
cooperation& effort
training &competency
supervision
feedbackmotivation
Accuracy and PrecisionAccuracy and Precision
2.703.003.30
Mean 3.00
Accurate, but not very precise
2.702.682.73
Mean 2.70
Precise, but not very accurate
3.00
Spirometry QC*Spirometry QC*Test How Often What To Do
Volume within ±3.5% of 3 L (2.895 – 3.105)Volume within ±3.5% of 3 L (2.895 – 3.105) 3 Flows between 0.5 – 12 L/sec (inject volume 3 Flows between 0.5 – 12 L/sec (inject volume
between 6 seconds and 0.5 seconds)between 6 seconds and 0.5 seconds) Weekly linearity (high, medium, low flows)Weekly linearity (high, medium, low flows) Disposable flow sensors – check 1 at least dailyDisposable flow sensors – check 1 at least daily
Flow or volume transducer meets standards for spirometry
N2 analyzer zeroed with 100% O2; spanned with air (78.1 ± 0.5%)
Linearity check every 6 months with certified gas or dilution technique (0.5% of expected)
Adjustable large volume syringe (3 L) may be used to simulate patient maneuver
Biologic controls (monthly)
NN22 Washout QC Washout QC
3 Liter syringe
He Dilution Lung Volume QCHe Dilution Lung Volume QC
Check for leaks every 24 hours or after circuit changes
Check water level if necessary Check gas conditioning columns (CO2, water) Check function of fan or blower He analyzer stable; drift < 0.02% for 10 minutes He analyzer linearity using serial dilutions -