ORIGINAL RESEARCH

Accuracy and Quality of Spirometry in Primary Care Offices

Matthew J. Hegewald1,2, Heather M. Gallo1, and Emily L. Wilson1
1
Intermountain Healthcare, Murray, Utah; and 2University of Utah, Salt Lake City, Utah

Abstract Measurements and Main Results: Only 1 of 17 spirometers

Rationale: Spirometry is necessary for the optimal management
of patients with respiratory disease. The quality of spirometry
performed in the primary care setting has been inconsistent.
Objectives: We aimed to evaluate spirometer accuracy, determine
the clinical significance of inaccurate spirometers, and assess the
quality of spirograms obtained in primary care offices.
Methods: We tested 17 spirometers used in primary care offices
with a waveform generator; accuracy and precision were assessed
using American Thoracic Society criteria. The clinical significance of
inaccurate instruments was determined by applying the FEV1/FVC
error from an obstructed waveform to a clinical data set. Spirogram
quality was determined by grading spirograms using acceptability
and repeatability criteria. The relationship between the number
of tests performed by a clinic and test quality was assessed.
met accuracy criteria, with mean errors for FVC, FEV1, and
FEV1/FVC ranging from 1.7 to 3.1%. Applying the percentage
error to a clinical data set resulted in 28% of tests being recategorized
from obstructed to nonobstructed. Of the spirograms reviewed,
60% were considered acceptable for clinical use. There was no
association between the number of tests performed by a clinic
and spirometry quality.
Conclusions: Most spirometers tested were not accurate. The
magnitude of the errors resulted in significant changes in the
categorization of patients with obstruction. Acceptable-quality
tests were produced for only 60% of patients. Our results raise
concerns regarding the utility of spirometry obtained in primary
care offices without greater attention to quality assurance and
training.
Keywords: spirometry; pulmonary function test

(Received in original form May 31, 2016; accepted in final form September 6, 2016 )
Supported by Intermountain Healthcare. The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation
of the data; or the decision to submit the manuscript for publication.
Author Contributions: M.J.H. designed the study, had full access to all of the data in the study, takes responsibility for the integrity of the data and the accuracy
of the data analysis and interpretation, and the writing of the manuscript. H.M.G. contributed to data acquisition and data analysis. E.L.W. contributed to
statistical analysis and data analysis.
Correspondence and requests for reprints should be addressed to Matthew J. Hegewald, M.D., Intermountain Medical Center, 5132 South Intermountain
Drive, Murray, UT 84157. E-mail: matt.hegewald@imail.org
Ann Am Thorac Soc Vol 13, No 12, pp 2119–2124, Dec 2016
Copyright © 2016 by the American Thoracic Society
DOI: 10.1513/AnnalsATS.201605-418OC
Internet address: www.atsjournals.org

Spirometry is an important tool in
diagnosing and managing patients with
respiratory disease, especially asthma and
chronic obstructive pulmonary disease
(COPD) (1, 2). Yet despite its importance,
spirometry is performed in less than 50% of
patients diagnosed with COPD (3–5) and
asthma (6). Patient care is optimized when
primary care providers are capable of
performing high-quality spirometry, as they
manage most patients with asthma and
COPD (7).
High-quality spirometry requires both
accurate spirometers and good coaching by
motivated and trained technicians. Today,
many lightweight, inexpensive, and user-
friendly spirometers are available for office
use (8). Office spirometers have been shown
to be accurate when tested under ideal
laboratory conditions. However, when
tested in “real-world” conditions, their
performance is variable (9–14). In addition
to inconsistent technical performance,
studies assessing the quality of spirometry
obtained in primary care offices have also
produced mixed results (15–18).
The American Thoracic Society (ATS)
and European Respiratory Society (ERS)
Task Force provides standards for
spirometer accuracy and precision and
recommends using a computer-driven
mechanical syringe, or its equivalent, to test
spirometer performance (19). The ATS/ERS
also provides guidelines for acceptable
spirometry test performance (19).
This study has four aims: (1) evaluate
the accuracy of spirometers used in primary
care offices, (2) assess the quality of
spirograms obtained by primary care
offices, (3) determine the association
between the number of spirometry tests
performed by a clinic and spirometer

Hegewald, Gallo, and Wilson: Spirometry Performance in Primary Care 2119


accuracy and test quality, (4) determine
the clinical significance of inaccurate
spirometers in diagnosing airway
obstruction. This work was previously
presented in abstract form (20).
Methods
As part of a quality improvement project,
we identified 16 primary care offices in the
Intermountain Healthcare system within
the Salt Lake City, Utah, metropolitan area
that performed spirometry at least weekly.
Institutional review board approval was
obtained; informed consent was waived for
this retrospective study.
Spirometer Testing
All office spirometers were tested at
Intermountain Medical Center by one
experienced technician over a 4-month
period. Instruments were set up and
calibrated or verified with a 3-L
syringe according to manufacturer
recommendations. Specifically, of the
three brands of instruments tested, only
the KoKo PFT System (nSpire Health,
Inc., Longmont, CO) requires 3-L syringe
calibration; KoKo spirometers were
calibrated with a 3-L syringe at varying flow
rates. The EasyOne (ndd, Andover, MA)
and Astra 300 (SDI Diagnostics, Easton,
MA) instruments do not require 3-L syringe
calibration. However, 3-L syringe
verification, with acceptable results,
was performed before testing.
Instrument accuracy and precision
testing were performed with a
computerized pulmonary waveform
generator (MH Custom Design and
Manufacturing L.C., Midvale, UT) as
previously described (21). Instruments
were tested using ambient conditions.
The waveform generator is a computer-
controlled mechanical syringe that delivers
the same waveform repetitively to within
less than 1.0 ml (21). Although the ATS
recommends testing instruments with
24 standard waveforms (22), we used an
expedited protocol using 8 waveforms
(numbers 1, 3, 8, 11, 15, 17, 18, and 23)
(22). The waveforms were chosen to
represent commonly observed ranges of
flows, volumes, initial efforts, and end-of-
test characteristics. Each waveform was
injected into the instruments five times.
Acceptable accuracy was defined as a
mean deviation from the standard ATS
2120
waveform value of less than 100 ml or
3.5% (whichever is greater) for FEV1 and
FVC. Acceptable precision was defined as
a measured range less than 100 ml or
range percentage (100 3 range/mean)
less than 3.5% (whichever is greater).
No more than one accuracy error and
one precision error were allowed across
the eight waveforms tested for either
FEV1 or FVC measurements (22).
The ATS has not provided accuracy
recommendations for FEV1/FVC ratio (22).
We defined acceptable accuracy
for FEV1/FVC ratio as a mean deviation
from the standard ATS waveform value
of less than 3.5%.
Assessment of Spirometry Quality
Each primary care office was asked to
provide 10 recent consecutive spirograms
from patients older than 10 years of age.
The offices were asked to remove specific
patient identifiers from all spirometry tests
before their transmission to Intermountain
Medical Center, Murray, Utah for quality
review. No site routinely administered
bronchodilator; only prebronchodilator
tests were analyzed. Spirograms were
graded (A through F) as recommended
by the National Lung Health Education
Program on the basis of acceptability
and repeatability criteria with minor
modifications (23). Tests were graded
based on the following acceptability
criteria (19):
1. Start of test criteria included: back
extrapolated volume less than 150 ml
or 5% of FVC (whichever is greater)
and peak expiratory flow greater than
3.0 L/s;
2. End-of-test criteria included:
exhalation time greater than
6.0 seconds or greater than 4.0 seconds
with a plateau on the volume–time
curve defined as less than 25 ml
volume exhaled in last second;
3. Absence of major cough, extra breaths,
or hesitation.
An acceptable maneuver required all three
criteria to be satisfied.
Repeatability grading for FEV1 and
FVC, defined as the difference between
the largest and next largest value, were:
A < 75 ml, B = 76–150 ml, C = 151–200 ml,
D = 201–250 ml, F . 250 ml.
One author (M.J.H.) evaluated each
spirogram for acceptability and repeatability
and determined an overall quality grade.
AnnalsATS Volume 13 Number 12 | December 2016
ORIGINAL RESEARCH
A quality grade was determined using the
following criteria (modified from Ferguson
and colleagues [23]):
A = a minimum of three maneuvers with
two acceptable maneuvers and a
repeatability grade for both FEV1 and
FVC of A
B = a minimum of three maneuvers with
two acceptable maneuvers and a
repeatability grade for both FEV1 and
FVC of B or better
C = two acceptable maneuvers and a
repeatability grade for both FEV1 and
FVC of C or better
D = one acceptable maneuver and a
repeatability grade for both FEV1 and
FVC of D or F
F = no acceptable results
Tests graded A, B, and C were considered
adequate for clinical use, whereas tests
graded D and F were not.
Each primary care office also provided
information on the number of patients
tested per week (1–5, 6–10, .10), the
number of personnel performing
spirometry, and whether the testing
personnel received any formal spirometry
training.
Association between Number of
Spirometry Tests Performed
and Spirometer Accuracy and
Test Quality
Clinic spirometry volume was classified
as either low (<10 tests/wk) or high
(.10 tests/wk). Wilcoxon rank sum tests
were used to assess the association between
the number of spirometry tests performed
by a clinic and accuracy of FVC, FEV1,
and FEV1/FVC ratio, as well as test quality
as measured by the percentage of tests
receiving an acceptable quality grade
(A, B, or C).
Clinical Significance of
Inaccurate Spirometers
The clinical significance of the accuracy
errors in FEV1/FVC ratio was determined
by applying the percent accuracy error
for FEV1/FVC ratio for waveform #17
(an obstructive pattern with FEV1/FVC
ratio = 0.445) to a clinical data set of
patients with obstruction obtained at
Intermountain Medical Center from 2010
to 2013. Obstruction was defined as a
prebronchodilator FEV1/FVC ratio below
the fifth percentile of the predicted value,
using National Health and Nutrition
 ORIGINAL RESEARCH
Examination Survey III reference
equations (24). The mean percentage
error for inaccurate instruments
(defined as an FEV1/FVC accuracy
error . 3.5%) was used to adjust the
measured FEV1/FVC ratio for the
clinical spirograms to determine
the percent of patients who would
have been inaccurately reclassified
from obstructed to nonobstructed.
Results
Spirometer Testing
A total of 17 spirometers representing
three different manufacturers used in 16
primary care clinics were tested with the
pulmonary waveform generator (one clinic
used two spirometers). The number and
models of spirometers tested were: 12 KoKo
PFT System; 3 EasyOne; and 2 Astra 300.
Table 1 provides the spirometer model,
number of spirometry tests performed per
week, and number of personnel performing
testing for each site.
Although six clinics performed more
than 10 tests per week, no clinic performed
more than 22 tests per week on average. None
of the locations used registered pulmonary
function technicians, and no technicians
received any formal spirometry training.
Most sites had multiple office personnel
perform testing (median, 5; range, 1–15).
Medical assistants performed testing at
most sites.
Table 1. Spirometer manufacturer, average testing volume per week, and number of
personnel performing spirometry testing for each of the 16 sites
Site Spirometer No. of Tests per Week
1 KoKo PFT System
2 KoKo PFT System
3 KoKo PFT System
4 EasyOne
5 KoKo PFT System
6 KoKo PFT System
7a KoKo PFT System
7b KoKo PFT System
8 KoKo Trek PFT
9 EasyOne
10 EasyOne
11 Astra 300
12 KoKo PFT System
13 KoKo PFT System
14 Astra 300
15 KoKo PFT System
16 KoKo PFT System
Hegewald, Gallo, and Wilson: Spirometry Performance in Primary Care
Accuracy and precision results for most common reason for test failure
the 17 spirometers for FEV1, FVC, and was inability to meet end-of-test
FEV1/FVC ratio are listed in Table 2. criteria (37 [61%]). Other reasons for
Only one spirometer met specified accuracy spirogram quality failure included poor
criteria (no more than one accuracy error repeatability (27 [44%]), start-of-test
for FEV1 and FVC). The mean absolute failure (22 [36%]), and body-of-test
accuracy error for FVC was 3.1% failure (cough, transient glottis closure,
(range, 1.0–7.1%) and 140 ml (range, extra breath) (8 [13%]). Approximately
46–305 mL); for FEV1 the mean absolute 40% of the tests failed more than one
accuracy error was 2.3% (range, criterion.
0.4–7.2%) and 72 ml (range, 7–200 ml).
The mean absolute accuracy error for Association between Number of
FEV1 /FVC was 1.7% (range, 0.6–3.4%). Spirometry Tests Performed and
Most spirometers (10 of 17) failed to Spirometer Accuracy and Test Quality
accurately measure FEV1 /FVC ratio for The number of spirometry tests that a clinic
waveform #17 (obstructed waveform), with performed was not significantly associated
all instruments overmeasuring FEV1/FVC with accuracy of FVC, FEV1, or FEV1/FVC
ratio; these failures were attributable to ratio. Low-volume clinics produced
undermeasurement of FVC due to early test acceptable-quality tests 57% of the time;
termination. Precision errors were less in high-volume clinics, 68% of the tests
common; only four instruments failed to were acceptable. This difference was not
meet precision criteria. The mean precision significant.
error for FVC was 1.2% and 49 ml and for
FEV1 was 0.6% and 15 ml. Clinical Significance of
Inaccurate Spirometers
Assessment of Spirometry Quality The clinical significance of inaccurate
Clinical spirograms were provided by spirometers in diagnosing airflow
14 clinics (two did not provide tests). obstruction was assessed by applying
We reviewed 153 spirograms, an the mean accuracy error to a data set
average of 10.9 per clinic (range, 9–16). with obstruction. Ten spirometers
Spirogram grades and the percentage of did not meet accuracy criteria for
tests acceptable for clinical use (grades FEV1/FVC ratio (defined as an accuracy
A, B, and C) are listed in Table 3. Of error . 3.5%) using waveform #17; all
the 153 spirograms, 92 (60%) were overestimated the FEV1/FVC ratio with a
graded acceptable and 61 (40%) mean accuracy error of 5.84% (range,
unacceptable (grades D or F). The 3.56–6.61%). Applying this mean
accuracy error to the FEV1/FVC ratio in
our clinical data set of 3,934 obstructed
spirograms resulted in a recategorization
of 1,114 (28%) tests from obstructed to
nonobstructed.
No. of Personnel
Testing
Discussion
.10 2
.10 1 Quality spirometry is crucial for diagnosing
1–5 2 and managing patients with respiratory
1–5 4 disease (1, 2, 23). Most patients with asthma
.10 2 and COPD are managed by primary care
6–10 5
.10 15 providers, and optimal management
.10 15 requires ready access to accurate
1–5 6 spirometry (7). However, high-quality
1–5 5 spirometry in the primary care setting
1–5 7 is not a simple endeavor; it requires:
1–5 7
1–5 6 (1) accurate and precise spirometers,
1–5 3 (2) proper maintenance of the equipment,
1–5 8 (3) motivated and trained technicians who
.10 10 know and adhere to spirometry guidelines/
1–5 2
standards, (4) appropriate reference
2121
 ORIGINAL RESEARCH

Table 2. Accuracy and precision results for the 17 spirometers tested

Site FVC Accuracy Error FEV1 Accuracy Error FEV1/FVC Accuracy Error FVC Precision Error FEV1
(%, ml, No. of (%, ml, No. of (%, No. of (%, ml, No. of Precision Error
Waveforms Failed) Waveforms Failed) Waveforms Failed) Waveforms Failed) (%, ml, No. of
Waveforms Failed)

1 3.7, 174, 5 2.0, 69, 2 2.0, 2 1.0, 48, 1 0.5, 15, 0

2 4.0, 188, 5 3.0, 98, 3 1.4, 2 3.0, 103, 1 0.1, 5, 0
3 6.0, 248, 7 7.2, 200, 6 2.6, 3 1.3, 65, 1 0.5, 11, 0
4 1.2, 52, 1 1.4, 50, 1 0.4, 0 1.0, 45, 0 0.8, 23, 0
5 2.9, 141, 4 3.7, 108, 3 3.4, 2 0.7, 29, 0 0.5, 13, 0
6 2.8, 135, 4 1.6, 65, 2 1.5, 2 1.3, 61, 2 0.6, 23, 1
7a 2.0, 92, 3 1.1, 35, 1 1.8, 2 2.3, 86, 3 0.6, 13, 0
7b 3.9, 177, 6 2.1, 73, 2 2.0, 2 1.9, 60, 2 0.4, 10, 0
8 1.3, 67, 2 1.7, 55, 1 1.6, 1 0.4, 15, 0 0.4, 11, 0
9 1.0, 47, 2 1.1, 45, 2 0.6, 0 1.4, 58, 1 1.6, 38, 0
10 1.0, 46, 2 1.4, 44, 2 0.6, 0 1.7, 69, 2 1.4, 31, 0
11 3.2, 129, 3 0.4, 7, 0 3.6, 4 0.8, 29, 0 0.4, 10, 0
12 3.5, 167, 5 2.1, 75, 2 1.6, 2 0.3, 14, 0 0.4, 9, 0
13 3.7, 163, 6 2.4, 78, 2 1.4, 1 1.2, 44, 1 0.4, 10, 0
14 2.9, 124, 3 0.9, 26, 0 3.3, 3 1.7, 79, 1 0.4, 11, 0
15 2.5, 118, 4 1.6, 61, 2 1.1, 0 0.3, 13, 0 0.3, 6, 0
16 7.1, 305, 8 5.1, 140, 8 0.6, 0 0.3, 9, 0 0.5, 10, 0
Mean 3.1, 140, 4.1 2.3, 72, 2.3 1.7, 1.5 1.2, 49, 0.9 0.6, 15, 0.1

equations, and (5) careful and informed Spirometer accuracy was not affected by this assessment may overstate the clinical
interpretation. the number of tests a clinic performs. impact of instrument inaccuracy, as ATS
We found that only 1 of 17 office The spirometers were generally precise. waveform #17 represents a significant
spirometers met the ATS recommended The clinical significance of the obstruction pattern.
combined accuracy and precision criteria inaccurate spirometers was quantified by Reasons for the inadequate
when tested with a pulmonary wave applying the percent accuracy error for spirometer accuracy are not clear. The
generator (22). Although the average FEV1/FVC ratio for waveform #17 (an three models of office spirometers in this
absolute accuracy errors for FVC (3.1% obstructive pattern) to a clinical data set study are marketed as meeting ATS
and 140 ml), FEV1 (2.3% and 72 ml), and of obstructed patients. The mean accuracy recommendations, indicating that they were
FEV1/FVC ratio (1.7%) were small, seven error (5.84%) when applied to our clinical tested using a pulmonary wave generator,
instruments had mean errors for FVC data set resulted in recategorization of or its equivalent, and met the specified
or FEV1 exceeding 150 ml, the between- 28% of the obstructed spirograms to accuracy and precision criteria (19, 22). The
maneuver repeatability criteria nonobstructed, potentially changing spirometers we tested had been in use for
recommended by the ATS/ERS (19). management. We acknowledge that between 6 months and 10 years (mean,
approximately 4 yr); it is possible that
inadequate maintenance and failure to
Table 3. Spirogram quality grades for the 14 clinics providing tests update software contributed.
None of the clinics performed 3-L
Site No. of Spirograms % of Spirograms A B C D F syringe testing for calibration or verification
Graded Receiving Acceptable as recommended by the ATS/ERS (19).
Grade (A, B, or C) Of the three spirometer models tested,
two (EasyOne and Astra 300) do not have
1 9 67 2 3 1 3 0 manufacturer instructions requiring routine
2 10 30 0 2 1 6 1 calibration with a 3-L syringe. There is
3 10 70 4 0 3 3 0 evidence that supports the EasyOne
4 13 23 2 1 0 8 2
5 10 90 7 2 0 1 0 manufacturer’s claim that it maintains
6 11 0 0 0 0 10 1 accuracy and does not require calibration
7a, 7b 11 73 4 0 4 3 0 for up to 26 weeks (25). The KoKo
8 10 50 1 3 1 5 0 manufacturer recommends at least daily
9 11 82 5 3 1 2 0 calibration with a 3-L syringe. Failing to
11 16 63 7 3 0 6 0
12 10 60 3 1 2 3 1 comply with recommended spirometry
13 11 82 4 3 2 2 0 quality-control processes is common,
14 10 80 6 1 1 2 0 with one study reporting that only 1.5%
15 11 82 4 3 2 2 0 of primary care offices perform daily
Total 153 60 49 25 18 56 5
calibration checks (26), and likely

2122 AnnalsATS Volume 13 Number 12 | December 2016

 ORIGINAL RESEARCH
contributed to suboptimal spirometer
accuracy.
Our study is not the first to
document suboptimal spirometer
performance in the primary care setting.
Another study compared 10 office
spirometers with 3 pulmonary function
laboratory–based spirometers and found
that 7 of the 10 office spirometers did not
meet specified accuracy or precision
criteria, potentially misclassifying
patients with obstructive lung disease
(8). They cautioned that office- and
laboratory-based spirometry results are
not interchangeable. However, smaller
studies comparing single portable
spirometers with laboratory-based
spirometers have reported acceptable
accuracy (11, 13).
In addition to the suboptimal
spirometer performance, the quality of
tests was also lacking. Only 60% of
spirograms were acceptable for clinical
use (grades A, B, or C). The ability to
produce adequate-quality tests was not
affected by clinic spirometry volume. In
comparison, an academic hospital–based
pulmonary function testing laboratory
reported obtaining acceptable and
repeatable spirometry (grades A or B)
in 90% of 18,000 adult patients (27).
We found the most common reason for
unacceptable spirometry was failure to
meet end-of-test criteria (61%). This
occurred despite less stringent end-of-
test criteria than recommended by the
ATS/ERS (19). End-of-test failure is
clinically important, as it results in an
increased FEV1 /FVC ratio, leading to
the misclassification of some obstructed
patients as nonobstructed (28). Other
common causes for unacceptable tests
were poor repeatability (44%) and
start-of-test failure (36%). Inadequate
spirogram quality occurred despite
software on all of the instruments that
provided immediate automated quality-
control feedback.
Several studies have addressed the
quality of spirometry in the primary care
setting (15–18, 29–33). These studies had
different designs and produced markedly
different results. Most assessed the effect of
spirometry training of varied intensity on
spirometry quality. Some studies found that
training had minimal effect on spirometry
quality (16, 30, 32). In contrast, other
studies that incorporated intensive training
(2–3.5 d) found that acceptable spirometry
Hegewald, Gallo, and Wilson: Spirometry Performance in Primary Care
could be obtained in most patients
(18, 29, 33).
There are many potential
explanations for the less-than-optimal
spirometry test quality. Lack of formal
spirometry training, such as courses
offered by the National Institute for
Occupational Safety and Health, is likely
the main factor. None of the technicians
had received formal training. Also, most
clinics had multiple staff members
perform spirometry; limiting testing to
a few motivated and trained technicians
may improve quality. In addition, most
clinics had low testing volume (one to
five tests per week). However, our results
and another study found no correlation
between the number of spirometry tests
performed and quality (32).
Our study questions the usefulness
of the broad application of screening
spirometry by primary care providers,
as recommended by national guidelines
(23), without significant changes in
quality-control measures. Certainly,
routine use of 3-L syringe testing for
calibration or verification is needed.
Although having primary care practices
perform spirometry is a practical and
efficient means of achieving widespread
testing, satisfactory testing may not be
an achievable goal.
Providing intensive training to a
limited number of motivated providers
will likely improve spirometry quality but
may not be reasonable for busy clinics
with high staff turnover. Limiting
spirometry testing to primary care clinics
with proven proficiency or referring
patients to a hospital or pulmonary
specialist’s pulmonary function
laboratory has been suggested (34).
However, this is not an efficient option
for patients, increasing time and travel
burdens, or for physicians, as it may delay
diagnosis and therapy initiation (18, 35).
Limiting spirometry testing locations
also only exacerbates the problem of
undertesting; less than 50% of patients
with a reported diagnosis of asthma or
COPD have undergone spirometry (3–6).
Replacing spirometry with peak-flow
measurement has been advocated but
cannot reliably replace spirometry for
diagnosing obstruction or determining
obstruction severity (36–39).
The most common reason for
suboptimal spirometry performance was
failure to meet end-of-test criteria, defined
either as an exhalation time less than
6.0 seconds or absence of a plateau on
the volume–time curve. Substituting
FEV1/FEV6 ratio for FEV1/FVC ratio is
an acceptable alternative for diagnosing
obstruction or a restricted spirometry
pattern and would likely result in
improvement in the number of acceptable
spirograms (40). One option for obtaining
acceptable spirometry may be electronic
transmission of spirograms from primary
care offices to an expert for quality review
and to provide feedback.
Limitations
The ATS recommends testing instruments
with 24 standard waveforms (22). We
used only eight waveforms for expediency
but chose waveforms that represented
commonly observed ranges of flows,
volumes, initial efforts, and end-of-test
characteristics. Ambient air was used
during testing, and appropriate correction
for this gas condition was applied.
Heated and humidified test gas was not
used, as has been recommended for
validation testing (22).
It could be argued that the acceptability
and repeatability criteria are unnecessary
as long as there is one adequate test that
is normal. A single normal spirogram
excludes the diagnosis of obstruction or
a restrictive spirometry pattern. However,
accurate and repeatable tests are important
when comparing changes over time.
The study was limited to a single
geographic region in the United States and
a single health system. It is not known if
these results are representative of other
region in the United States.
Conclusions
Only 1 of 17 primary care spirometers tested
met accuracy criteria. Although the accuracy
errors were generally small, some errors
of potential clinical significance were
detected. Spirometer performance was
notably lacking in the measurement of
an obstructed waveform. In addition to
suboptimal spirometer performance,
clinically acceptable spirograms were
produced for only 60% of patients. These
results raise concerns regarding the ability
of primary care offices to obtain quality
spirometry without greater attention to
quality assurance and training. n
Author disclosures are available with the text
of this article at www.atsjournals.org.
2123

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AnnalsATS Volume 13 Number 12 | December 2016