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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,

Dec 29, 2015

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Page 1: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Quality ControlQuality ControlSpirometry & Lung VolumesSpirometry & Lung Volumes

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

Page 2: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

What Quality Control IsWhat Quality Control Is

NOT !!

Page 3: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

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

Page 4: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

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

Page 5: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

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

Page 6: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

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

Page 7: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Spirometry QC*Spirometry QC*Test How Often What To Do

Volume Daily Calibration check using 3 L syringe

Leak (volume spirometers)

Daily 3 cmH2O for 1 minute

(< 30 ml volume loss)

Volume linearity

Quarterly 1 L volumes over entire range of device

Flow linearity Weekly 3 flow ranges

Timer Quarterly Stopwatch

Software Whenever changed

Log and check biologic control

* ATS/ERS 2005

Page 8: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Calibration/Verification Calibration/Verification SyringesSyringes

3 Liter recommended ± 15 ml or 0.5% full

scale 3.5% for spirometer

calibration checks Keep syringe at same

conditions as spirometer

‘Computerized’ syringes

Page 9: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Syringe CalibrationSyringe CalibrationCalibrating the CalibratorCalibrating the Calibrator

Annual calibration of syringe recommended

Page 10: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Calibration Check – Calibration Check – Volume SpirometersVolume Spirometers

Daily leak check Volume within ±3.5% of 3 L (2.895 – 3.105) Quarterly linearity check across volume range

Page 11: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Is Is ± ± 3.5% good enough? *3.5% good enough? *Calibration Check – Volume SpirometersCalibration Check – Volume Spirometers

* McCormack et al. Chest 2007; 131:1486-1493

Page 12: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Calibration Check – Calibration Check – Flow SpirometersFlow Spirometers

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

Page 13: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Calibration Check – Calibration Check – Flow SpirometersFlow Spirometers

Page 14: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

PFT2 Volume Calibration

-3

-2

-1

0

1

2

3

0 7 14 21 28 35 42 49 56 63 70 77

Days

% E

rro

r

Expiratory Inspiratory

Calibration Check – Calibration Check – Flow SpirometersFlow Spirometers

Page 15: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Other QC TechniquesOther QC Techniques

Syringe flow-volume loops (simulate patient) Biologic control (normal subject)

Page 16: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Body Plethysmograph QCBody Plethysmograph QC

Flow transducer accuracy same as for spirometry

Box pressure and mouth pressure transducers calibrated (physical) daily

Isothermal lung analog (± 50 ml or 3%) Biologic controls (2 subjects monthly or

when problems are suspected)

Page 17: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Physical Calibration Body BoxPhysical Calibration Body Box

Page 18: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Isothermal Lung AnalogIsothermal Lung Analog Subject sits in box with jar Subject sits in box with jar

(holds breath)(holds breath) Compress hand bulb at Compress hand bulb at

0.5-1.0 Hz Hz Record VRecord VTGTG tangent tangent Calculate ‘FRC’ of jar Calculate ‘FRC’ of jar

ATPSATPS Volume of jar = volume of Volume of jar = volume of

water + connectors – water + connectors – metal woolmetal wool

Page 19: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Biologic Controls for Biologic Controls for PlethysmographyPlethysmography

2 subjects 2 subjects representative of representative of patient populationpatient population

Perform VPerform VTGTG according

to standard to standard guidelinesguidelines FRC and TLC should FRC and TLC should

be within 10% of mean be within 10% of mean for each controlfor each control

Lung Volumes – Biologic Control

Liters

VTG TLCPLETH

Page 20: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

NN22 Washout Lung Volume QC Washout Lung Volume QC

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)

Page 21: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

NN22 Washout QC Washout QC

3 Liter syringe

Page 22: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

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 -

check quarterly

Page 23: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

He Dilution QCHe Dilution QC

Linearity Check

Page 24: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Lung Volumes QCLung Volumes QC

Mean 3.38 3.42 3.57

std 0.15 0.20 0.15

cv 4.5% 5.7% 4.3%

N 11 11 12

He N2 BoxBiologic* Control

* Looks good on your resume

Page 25: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Selecting Biologic ControlsSelecting Biologic Controls

No history of respiratory No history of respiratory disease (asthma)disease (asthma)

No symptomsNo symptoms Non-smoker (< 5 pk-yrs Non-smoker (< 5 pk-yrs

and 10 years quit)and 10 years quit) Readily available for Readily available for

testingtesting

Page 26: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Handling Control DataHandling Control Data

Page 27: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Biologic Control DataBiologic Control DataPFT Quality Control (HAW)Medical Graphics BreezePF

3.82

2.81

2.11

2.98

2.88

5.49

3.84

2.81

2.09

2.96

2.85

5.48

3.83

2.86

2.22

3.17

2.76

5.45

3.82

2.87

2.24

0.00

1.00

2.00

3.00

4.00

5.00

6.00

FVC FEV1 FEF25-75 N2-FRC Pl-FRC Pl-TLC

Mean Volumes by Test

Vol

ume

(lite

rs)

Room 1 PFT2 TenetCare PFT3 TenetCare PFT6 MGC

Page 28: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Free Spreadsheet !Free Spreadsheet !

Request “Generic Biocontrols” fromRequest “Generic Biocontrols” from

[email protected]@aarc.com

Page 29: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Biologic Control DataBiologic Control Data

http://www.ezyqc.co.nz

Disclosure: I received a free copyof the software as a beta tester

Page 30: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Biologic Control DataBiologic Control Data

Page 31: Quality Control Spirometry & Lung Volumes Gregg L. Ruppel, MEd, RRT, RPFT, FAARC Adjunct Professor, Pulmonary, Critical Care & Sleep Medicine Director,

Thanks !Thanks !

Gregg RuppelGregg Ruppel

Pulmonary Function LabPulmonary Function Lab

St. Louis University HospitalSt. Louis University Hospital

[email protected]@slu.edu