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Spirometry Testing inSpirometry Testing inOccupational Health ProgramsOccupational Health Programs
Best Practices for HealthcareProfessionalsMary C. Townsend, Dr.P.HM.C. Townsend Associates, LLCAdjunct Faculty, University of PittsburghPittsburgh, PA
http://www.osha.gov/Publications/OSHA3637.pdf
PLEASE STANDY BY – WEBINAR WILL BEGIN AT 12:00 PM PSTFOR AUDIO: CALL 888-740-1260 / ACCESS CODE: 764-4915#
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Speaker DisclosuresSpeaker Disclosures
Dr. Townsend - Independent consultant;Dr. Townsend - Independent consultant;teaches NIOSH-approved Spirometry Courses:teaches NIOSH-approved Spirometry Courses:
Companies, medical facilities (e.g. BASF, Alcoa, USS, GM,Companies, medical facilities (e.g. BASF, Alcoa, USS, GM,DuPont, DuPont, MedExpressMedExpress, UPMC), UPMC)
Federal agencies (e.g., OSHA, NIOSH, US Library ofFederal agencies (e.g., OSHA, NIOSH, US Library ofCongress, Branches of military)Congress, Branches of military)
Other entities (e.g., Johns Hopkins University).Other entities (e.g., Johns Hopkins University).
Not paid by Not paid by spirometerspirometer manufacturers, but accepts manufacturers, but acceptsloaner loaner spirometersspirometers for teaching purposes. for teaching purposes.
Acknowledgement
OSHA would like to thankACOEM and M.C. TownsendAssociates, LLC for theirassistance in preparing thisdocument.
http://www.osha.gov/Publications/OSHA3637.pdf
Disclaimer
This publication provides ageneral overview of astandards-related topic. It doesnot alter or determinecompliance responsibilitieswhich are set forth in OSHAstandards, and the OSH Act.
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Intended for medical personnel who overseeworker health programs, conduct spirometry tests,and/or interpret spirometry results.
Goal is to help ensure collection of accurate, validspirometry results that are interpreted correctly.
Such spirometry assessments can be used tomake well-informed decisions about workerrespiratory health (including the need for medicalreferrals), and to conduct programs for preventionand early intervention.
Purpose Of This Guide
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Importance of Guidance DocumentImportance of Guidance Document
Historically: 2nd OSHA statement about detailsHistorically: 2nd OSHA statement about detailsof occupational spirometry since Cotton Dustof occupational spirometry since Cotton DustStandard (29 CFR 1910.1043) Appendix D,Standard (29 CFR 1910.1043) Appendix D,1978.1978.
Most US employers do not process cotton, soMost US employers do not process cotton, sosome companies do not support high qualitysome companies do not support high qualityspirometry testing programs for workers.spirometry testing programs for workers.
Not mandatory compliance Not mandatory compliance regreg, but this, but thisGuidance explicitly states what OSHA regardsGuidance explicitly states what OSHA regardsas best practice in occupational spirometryas best practice in occupational spirometryprograms.programs.
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Changes Since 1978Changes Since 1978SpirometersSpirometers evolved evolved –– flow-type devices flow-type devices
developed, many with limited real-time displays.developed, many with limited real-time displays.
4 American Thoracic Society (ATS) Statements on4 American Thoracic Society (ATS) Statements onspirometry: 1979, 1987, 1994, and 2005; 2 ATSspirometry: 1979, 1987, 1994, and 2005; 2 ATSStatements on interpreting results: 1991 and 2005.Statements on interpreting results: 1991 and 2005.
ACOEM spirometry statements: 2000, 2005, 2011.ACOEM spirometry statements: 2000, 2005, 2011.
NHANES III research study, giving most accurateNHANES III research study, giving most accuratenormal ranges for interpreting results: 1999normal ranges for interpreting results: 1999
NIOSH spirometry course approval tightened up,NIOSH spirometry course approval tightened up,Refreshers NIOSH-approved from 2009 on.Refreshers NIOSH-approved from 2009 on.
1. Introduction1.1 Spirometry Overview
2. Accurately Measuring Worker Lung Function2.1 Personnel Involved In Spirometry Testing2.2 Equipment2.3 Conducting Spirometry Tests
3. Interpreting Test Results3.1 Comparing Worker Results With Normal Range (ReferenceValues)3.2 Evaluating Results Over Time
4. Quality Assurance (QA) Reviews5. Spirometry Procedure Manual6. RecordkeepingAPPENDIX A --- National Health And Nutrition Examination Survey III(NHANES III) Reference ValuesAPPENDIX B ---Spirometry Procedure Manual Checklist
Table of ContentsTable of Contents
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Measurements and DisplaysMeasurements and Displays
FForced orced VVital ital CCapacity (FVC)apacity (FVC) FForced orced EExpiratory xpiratory VVolume in olume in 11 Sec (FEV Sec (FEV11)) FEVFEV11/FVC %/FVC %
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FVC = 5.00 LFVC = 5.00 L
PEF = PEF = PPeak eak EExpiratory xpiratory FF lowlow
1 sec1 sec
FVC = 5.00 LFVC = 5.00 L
PEF = PEF = PPeak eak EExpiratory xpiratory FF lowlow
1 sec1 sec
Both displays Both displays during PFTduring PFT goodgoodcoachingcoaching Volume-TimeVolume-TimeCurveCurve –– End of Test End of Test
Flow-Volume CurveFlow-Volume Curve–– Effort in 1st sec Effort in 1st sec
Volu
me
Time
Flow
FVC = 5.00 LFVC = 5.00 L
FEVFEV 11= 3.80 L= 3.80 L
FVC = 5.00 LFVC = 5.00 L
FEVFEV 11= 3.80 L= 3.80 L
FEV1/FVC = 76%FEV1/FVC = 76%
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2.0 Accurate Measurements2.0 Accurate Measurements
Personnel: roles of Personnel: roles of PLHCPsPLHCPs, technicians, technicians
SpirometersSpirometers: accuracy, validation testing,: accuracy, validation testing,cal checks, purchasing new equipmentcal checks, purchasing new equipment
Conducting tests: preparation, posture,Conducting tests: preparation, posture,performing tests, achieving valid tests,performing tests, achieving valid tests,measurements to be reportedmeasurements to be reported
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2.1 Spirometry Testing PersonnelOSHA states:
“The most important quality of a pulmonaryfunction technician is the motivation to do thevery best test on every employee.
The technician must also be able to judge thedegree of effort and cooperation of the subject.
The test results obtained by a technician wholacks these skills are not only useless, but alsoconvey false information which could beharmful to the employee.”
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ATS/ERS 2005, OSHA 2013ATS/ERS 2005, OSHA 2013CautionsCautions Interpretation begins with review and comment on testInterpretation begins with review and comment on test
quality.quality.
Relying only on numerical results for clinical decisionsRelying only on numerical results for clinical decisionsis a common mistake, is a common mistake, easily made by those whoeasily made by those whodepend on computer interpretations.depend on computer interpretations.
When interpreting spirometry results, medicalWhen interpreting spirometry results, medicalpersonnel should evaluate the technical qualitypersonnel should evaluate the technical qualityof the test and not rely solely on numericalof the test and not rely solely on numericalresults and computer interpretations.results and computer interpretations.
OSHA 3637-2013OSHA 3637-2013
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2.1.1 PHLCP Training2.1.1 PHLCP Training Spirometry program supervisors and directors needSpirometry program supervisors and directors need
to: 1) understand what makes tests valid, and 2)to: 1) understand what makes tests valid, and 2)recognize flawed results.recognize flawed results.
Effective PLHCP oversight helps correct problemsEffective PLHCP oversight helps correct problemsquickly and repeat tests when needed.quickly and repeat tests when needed.
OSHA recommends: supervisors and/orOSHA recommends: supervisors and/orinterpreters of results take NIOSH-approvedinterpreters of results take NIOSH-approvedspirometry courses or equivalent training so theyspirometry courses or equivalent training so theycan oversee programs effectively.can oversee programs effectively.
Such training must emphasize recognizing andSuch training must emphasize recognizing andtrouble-shooting technical errors and how totrouble-shooting technical errors and how tointerpret spirometry results.interpret spirometry results.
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Some OSHA standards specifically require aspirometry training course for personnel whotest workers covered by those standards.
OSHA also recommends that:
1) all persons conducting occupationalspirometry tests should complete an initialNIOSH-approved spirometry course, and
2) attend NIOSH-approved Refresher coursesto maintain that certification over time.
2.1.1 Technician Training2.1.1 Technician Training
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2.2 Equipment2.2 Equipment
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2.2.1 Selecting a 2.2.1 Selecting a SpirometerSpirometer
Accuracy and precisionAccuracy and precision Validation testing by independent lab orValidation testing by independent lab or
manufacturermanufacturer Graphical displays Graphical displays during testingduring testing that are that are
large enough to help tech coach effectivelylarge enough to help tech coach effectively Graphical displays Graphical displays on reportson reports that are large that are large
enough to let interpreters evaluate testenough to let interpreters evaluate testvalidity effectivelyvalidity effectively
Features to look for in new Features to look for in new spirometersspirometers
See Page 9 ofthe OSHAGuidelinesDocument
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2.2.2 Checking 2.2.2 Checking SpirometerSpirometer Cal Cal
Volume Volume spirometerspirometer checks checks –– leaks, accuracy when leaks, accuracy when3-L injected, quarterly linearity check3-L injected, quarterly linearity check
Flow-type Flow-type spirometerspirometer checks - accuracy when 3-L checks - accuracy when 3-Linjected @ 6 L/s, 3 L/s, 0.5 L/sinjected @ 6 L/s, 3 L/s, 0.5 L/s
Care of cal syringeCare of cal syringe
Save equipment maintenance and cal check recordsSave equipment maintenance and cal check records
Failure to pass all spirometer checks indicates that workersshould not be tested until the cause of failure is identifiedand corrected, and the spirometer passes all of itscalibration checks.
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2.2.3 Recognize and Avoid Zero-Flow2.2.3 Recognize and Avoid Zero-FlowErrors and Sensor ContaminationErrors and Sensor Contamination
Sensor BlockedZero Error
Zero Error Zero Error
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Pre-test preparationPre-test preparation
Posture: Standing recommendedPosture: Standing recommended
Testing: Explain, demonstrate, coachTesting: Explain, demonstrate, coach
Valid testsValid tests have: have: 3 acceptable curves (attempt up to 8)3 acceptable curves (attempt up to 8)
Repeatable FVC and FEV1Repeatable FVC and FEV1 Highest Highest –– 2 2ndnd highest FVC is 0.15 L or less highest FVC is 0.15 L or less
Highest Highest –– 2 2ndnd highest FEV1 is 0.15 L or less highest FEV1 is 0.15 L or less
Report largest FVC, largest FEV1, even if differentReport largest FVC, largest FEV1, even if differentcurvescurves
2.3 Conducting Tests2.3 Conducting Tests
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DELETE These ErrorsDELETE These ErrorsHesitationFlow-Volume Curves
0
2
4
6
8
10
0 1 2 3 4 5Volume (L)
Flow
(L/
s)
1123.34Error
1093.23Good
FEV1% PredFEV1 (L)
HesitationHesitation
Hesita tionV o lum e-T ime C urv es
0
1
2
3
4
5
-2 -1 0 1 2 3 4 5 6 7 8 9 1 0T im e (s)
Volu
me
(L)
ErrorMaximal Effort
CoughFlow-Volume Curves
0
2
4
6
8
10
0 1 2 3 4 5Volume (L)
Flo
w (
L/s
)
992.95Error
1093.23Maximal
% PredFEV1
CoughVolume-Time Curves
0
1
2
3
4
5
0 1 2 3 4 5 6 7 8 9 10T ime (s)
Vol
ume
(L)
E rrorMaximal Effort
FEV1 ↑
FVC ↑
Cough
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Common Errors Common Errors Falsely L Falsely Low Valuesow Values
832.48853.11Error
1093.231073.93Maximal
% PredFEV1
% PredFVC
Submaximal InspirationVolume - Time Curves
0
1
2
3
4
5
0 2 4 6 8 10Time (s)
Vol
ume
(L)
Maximal Effort
Small Inspiration
Submaximal InspirationFlow-Volume Curves
0
2
4
6
8
10
0 1 2 3 4 5Volume (L)
Flo
w (
L/s
)
49631.86Error
821093.23Maximal
FEV1/FVC% % PredFEV1
0
2
4
6
8
10
0 1 2 3 4 5
Volume (L)
Flo
w (
L/s
)
0
1
2
3
4
5
0 1 2 3 4 5 6 7 8 9 10T ime (s)
Vo
lum
e (L
)
Maximal Effort
Error
No blastSmallinhale
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End of Test DefinitionEnd of Test Definition
25 yr 62” WF Obs % Pred
FVC 3.76 L 107 %
FEV1 3.30 112 %
FEV1/FVC 88% 105%
Time (FET) 4.5 sec --
Valid end of test:
1. Subject can’t/won’t continue;
2. Plateau achieved and subject tried to exhale for 6 or more sec;
3. Older or obstructed people usually >6 s, but should stop at 15 s.
Early Termination: Obstructionmay appear “Normal” Young worker plateaus before 6 s
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3.0 Interpreting Test Results3.0 Interpreting Test Results
Compare worker to normal rangeCompare worker to normal range Compare current FEV1 to previous FEV1sCompare current FEV1 to previous FEV1s
When interpreting spirometry results, medicalpersonnel should evaluate the technical qualityof the test and not rely solely on numericalresults and computer interpretations.
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3.1 Compare Worker to Normal Range3.1 Compare Worker to Normal Range
3.1.1 Select reference values3.1.1 Select reference values
OSHA recommends that spirometry results for workers in theUnited States be compared with NHANES III (Hankinson1999) reference values unless an OSHA standard requiresthat a different reference set be used.
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Racial group/ethnicity is based on Racial group/ethnicity is based on self-reportself-report..
NHANES III has race-specific values forNHANES III has race-specific values forCaucasian, African-American, and HispanicCaucasian, African-American, and Hispanicworkers, but not Asian-Americans.workers, but not Asian-Americans.
For Asian workers, apply 0.88 scaling factorFor Asian workers, apply 0.88 scaling factorto Caucasian FVC and FEV1 referenceto Caucasian FVC and FEV1 referencevalues. FEV1/FVC reference not adjusted.values. FEV1/FVC reference not adjusted.
If use NHANES, If use NHANES, ““race-adjustmentrace-adjustment”” factors factorsnot needed for non-Asians.not needed for non-Asians.
3.1.2 Race Adjustment of Predicted3.1.2 Race Adjustment of PredictedValues and LLNValues and LLN
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3.2 Evaluating Results Over Time - 13.2 Evaluating Results Over Time - 1-1. Why look at change over time?-1. Why look at change over time?
Exposures may accelerate age-related lossExposures may accelerate age-related loss
A few diseases have rapid FEV1 declineA few diseases have rapid FEV1 decline
Workers with baselines > 100% Workers with baselines > 100% predpred
-2. Technical and biological factors-2. Technical and biological factors Standardize and avoid changes in test protocolStandardize and avoid changes in test protocol
and equipmentand equipment
Train technicians and perform QA reviewsTrain technicians and perform QA reviews
Maintain equipment and keep recordsMaintain equipment and keep records
Minimize biological variabilityMinimize biological variability
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3.2 Evaluating Results Over Time - 23.2 Evaluating Results Over Time - 2-3. Frequency of testing-3. Frequency of testing
Varies with exposure, outcome, and regulationsVaries with exposure, outcome, and regulations
-4. Values that suggest abnormality-4. Values that suggest abnormality Evaluate only FEV1 over timeEvaluate only FEV1 over time 15% drop after aging effect may be excessive;15% drop after aging effect may be excessive;
maybe 10-15% if maybe 10-15% if spirometersspirometers accurate, good accurate, goodtechnical quality, deleterious exposurestechnical quality, deleterious exposures
-5. Interpreting change over time-5. Interpreting change over time Verify tests are good quality, adequate follow-up,Verify tests are good quality, adequate follow-up,
multiple factors may affect change, furthermultiple factors may affect change, furthermedical evaluation if repeat tests verify lossmedical evaluation if repeat tests verify loss
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4.0 QA Reviews4.0 QA Reviews
At least quarterly, review random sample ofAt least quarterly, review random sample ofreports, all invalid tests, sample of those withreports, all invalid tests, sample of those withFVC or FEV1 < LLN or > 130% FVC or FEV1 < LLN or > 130% predpred
Perform reviews more often for new techs orPerform reviews more often for new techs orif problems foundif problems found
Feedback to technician on errors, coachingFeedback to technician on errors, coachingsuggestions, suggestions, spirometerspirometer settings settings
Goal: at least 80% of total tests areGoal: at least 80% of total tests aretechnically valid technically valid –– if less, retraining needed if less, retraining needed
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6.0 Recordkeeping6.0 Recordkeeping
Spirometry Test Reports Spirometry Test Reports –– part of medical part of medicalrecord, save for 30 yrs after termination ofrecord, save for 30 yrs after termination ofemploymentemployment
Equipment Maintenance Records Equipment Maintenance Records –– support supportaccuracy of spirometry tests from same dateaccuracy of spirometry tests from same date QC LogQC Log
SpirometerSpirometer hardware, software changes hardware, software changes
Personnel training and evaluation recordsPersonnel training and evaluation records
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ConclusionConclusion Spirometry tests are intended to serve the purposeSpirometry tests are intended to serve the purpose
of accurately measuring and evaluating employeeof accurately measuring and evaluating employeepulmonary function.pulmonary function.
This guidance is intended to increase medicalThis guidance is intended to increase medicalprovider and employer understanding of how testsprovider and employer understanding of how testsshould be performed when undertaking theshould be performed when undertaking themeasurement of employee lung function.measurement of employee lung function.
Awareness of pitfalls to avoid and interpretativeAwareness of pitfalls to avoid and interpretativestrategies to use will make spirometry test resultsstrategies to use will make spirometry test resultsmeaningful and useful in protecting worker health.meaningful and useful in protecting worker health.
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For more information, go to: http://www.mctownsend.com
Download OSHA Best Practices Guidance at:
http://www.osha.gov/Publications/OSHA3637.pdf
