Spirometry Guideline
Spirometry Guideline
Spirometry Guideline
C ar
1. Purpose
This guideline provides recommendations to support high quality spirometry testing throughout
Queensland Health.
2. Scope
This Guideline provides information for all health professionals, and organisations who perform
spirometry on adult and paediatric patients in Queensland Health facilities.
This guideline provides the minimum requirements for obtaining acceptable and repeatable spirometric
data for pre/ post-bronchodilator responsiveness testing using flow-measuring devices.
This guideline assumes operator training in performing spirometry is completed and the attainment and
maintenance of competency is integrated in any spirometry testing service1.
Note: Thoracic Society of Australia and New Zealand (TSANZ) accredited respiratory laboratories, local
policy and procedure manuals that interpret the international standards should be used for conducting
spirometry testing.
3. Related documents
Standards, procedures and guidelines
• Standardisation of Spirometry 2019 Update1
• 2007 American Thoracic Society and European Respiratory Society Position statement: pulmonary
function testing in preschool children6
Forms, templates
• Nil
̵
For information relating to testing facility requirements when working with paediatric
patients, please refer to Appendix 3.
4.5.2. Spirometer
Spirometers must meet the minimum ATS/ERS recommendations which include
compliance with the International Organisation for Standardisation (ISO 26782)1
For information relating to testing equipment requirements when working with paediatric
patients, please refer to Appendix 3.
• infection control supplies: disposable in-line bacteria filters, gloves, gowns, masks and
protective eyewear when indicated
• calibrated scales (standing and sitting) that measure to a weight of at least 300 kg
• calibrated stadiometer for measuring height and a tape measure for arm span
measurement. (For paediatric patients: Harpenden Callipers may also be required for
measurement of ulna length when standing height cannot be measured, refer to
Appendix 57)
• chair with arms, without wheels, preferably height adjustable for small adults and
paediatric chairs for paediatric patients
• barometer, thermometer and hygrometer, if not integrated into the equipment used.
This equipment is used for correcting volumes to body temperature (i.e. 37 0C),
ambient pressure, air saturated with water vapour (BTPS)
For students and/or new staff commencing work within a TSANZ accredited respiratory
laboratory, training will be provided onsite. Other accredited spirometry training is also
available9 10.
For spirometry testing in preschool children, it is essential that the health practitioner
have the ability to establish rapport with the child, and that he or she is able to obtain
measurements without causing distress6.
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Additionally, when performing spirometry on a child, a Blue Card is required by staff who
are not registered health practitioners.
• In paediatrics, the expressed ratio of FEV1 /FVC is used in preference to FEV1 /VC.
• Queensland Health recommends The Global Lung Initiative (GLI) 2012 reference
equations11.
• Check the flow-sensors daily for holes, clogging, channel plugging, or excess moisture.
Refer to manufacturer’s guidelines if a problem is detected.
Ensure the patient has received education (written or verbal) regarding the necessary
preparation for effective testing conditions. Activities that should be avoided include1, 4 :
• smoking and/or vaping and/or water pipe use at least 1 hour before testing
• Carry out infection control measures prior to testing, particularly hand washing or use
of an approved hand disinfection gel or wipe, for both patient and personnel
performing spirometry.
- Check for completed and signed doctor’s request form, including indications and
contraindications to spirometry testing (see section 4.4 Indications and
Contraindications for performing spirometry)
- Confirm patient’s identity using at least three approved patient identifiers14 (e.g.
request the patient’s full name, address and date of birth and check the
procedure to be performed).
• Ensure the patient is wearing clothing that enables full chest and abdominal
expansion (if possible, loosen clothing).
• Assess patient for physical and developmental status to determine their ability to
perform the test and/or if special arrangements are required e.g. if the patient has a
tracheostomy.
• Record patient’s age in years (to one decimal place if the software allows).
• For individuals older than 25 years, where a reliable height measurement has been
made previously in the service, yearly height measurements are adequate1. For all
patients under the age of 25 years, height must be measured and recorded at each
visit. Measure and record height to the nearest 0.1 cm using an accurate and
validated measuring device (stadiometer). Refer to Appendix 5 for anthropometrical
measures for spirometry.
• Measure and record the patient’s weight in kilograms (kg) to the nearest 0.5 kg with
indoor clothing and without shoes. The weight is not required for most reference
values but may be useful for interpretative reasons.
• Record birth gender and gender identity. If needed, inform the patient that although
their gender identity is respected, it is their birth gender that is used to predict lung
size1 .
• Record ethnicity as this may affect the predicted lung size. Refer to Global Lung
Initiative (GLI) 2012 reference equations11 for correct classification and recording.
• Note: Instructions for withholding should be given to patients at the time of booking
an appointment.
• Note: The use of bronchodilator is at the patient and/or carer’s discretion despite the
recommendation to withhold before the test.
• Record testing position if not sitting and justification why test is performed in a non-
sitting position.
• In paediatric patient services, provide ample opportunity for the patient or carer to
ask questions or receive clarification on the test and its requirements. Young children
may not fully understand the requirements for the test but should be encouraged
enthusiastically.
In the open-circuit method the patient approaches the mouthpiece after a complete
inhalation to total lung capacity (TLC), whereas in the closed-circuit method the patient
inhales to TLC whilst firmly on the mouthpiece and after several tidal volume breaths on
the mouthpiece. Both methods are described below.
1. Introduce yourself to the patient, including your name and position title and establish
rapport.
- maximal inspiration
- a "blast” of expiration
- Attach nose clip, place mouthpiece in mouth (or assist patient in positioning
themselves on the mouthpiece) and instruct patient to close lips tightly
around the mouthpiece and breathe quietly for no more than 5 breaths (i.e.
relaxed, ‘normal’ tidal breathing).
- Instruct patient to inhale completely and rapidly until their lungs are full.
5. If a flow-volume loop is being performed (to measure forced inspiratory vital capacity)
the patient will exhale rapidly and forcefully until end of test criteria are achieved,
and then inhale as rapidly as possible back to TLC.
6. Observe the patient at all times during the manoeuvre in case they become unsteady
due to light-headedness or experience other adverse reactions such as chest pain or
syncope.
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7. Terminate the manoeuvre (using keyboard, mouse or special function keys as
specified by the manufacturer) once the end of test criteria has been met (see section
4.7.3 Determining acceptability and repeatability).
9. Terminate the test once the acceptability and repeatability criteria have been met
(see section 4.7.3 Determining acceptability and repeatability).
Note: The use of nose-clips is recommended even though they can sometimes
distract children.
Note: In paediatrics, the test procedure above should be adhered to with the
following exceptions:
- Correct posture with head slightly elevated for older children and in the
neutral position for younger children.
- More than eight manoeuvres can be attempted if necessary.
2. Have the patient assume correct posture and attach nose clip.
3. Activate the spirometer:
a) When using the open circuit method:
- Instruct the patient to inhale completely and rapidly until their lungs are full,
place the mouthpiece in the mouth and close lips tightly around the
mouthpiece while holding their lungs full.
- Instruct patient to exhale slowly and completely until their lungs are empty.
4. Encourage the patient to “keep going” until there is no volume change observed
(see section 4.7.3 Determining acceptability and repeatability).
5. Observe the patient at all times during the manoeuvre in case they experience
light-headedness or any other adverse reactions.
6. Terminate the manoeuvre (using keyboard, mouse or special function keys as
specified by the manufacturer) once the end of test criteria have been met (see
section 4.7.3 Determining acceptability and repeatability).
7. Repeat instructions and manoeuvres for a minimum of three manoeuvres,
coaching vigorously until end of test criteria are met; with a maximum of eight
attempts and a sufficient rest period between each manoeuvre1.
8. Terminate test once acceptability and repeatability criteria are met (see section
4.7.3 Determining acceptability and repeatability).
̵ Note: Some patients may not be able to use a standard mouth piece (for
example: patients with tracheostomy or nasal resection). The operator, at their
discretion, may try the use of facemasks, tubing connectors or occlusion valves
on these patients1
• Has a rapid start of test, that is, the back extrapolated volume (BEV) is <5% of FVC or <
0.100 L, whichever is greater (see Appendix 7). If the manoeuvre has an obviously
hesitant start the trial should be terminated early to avoid unnecessary prolonged
effort.
• The BEV ≤ 80ml and ≤ 10% to 12.5% of FVC6 15, then the curve is acceptable. 6. (More
rigorous criteria have been documented as acceptable: BEV ≤ 75 ml and ≤ 10% of
FVC)16. Note: curves not achieving this criterion should be reinspected, but need not
necessarily be excluded
3. max FVC is within the repeatability tolerance (≤0.150 L for patients >6 years of age;
≤0.100 L or 10 % of the highest value, whichever is greater for patients ≤ 6 years of
age) or greater than the largest prior observed FVC.
Note: EOFE 3) occurs when the patient cannot expire long enough to achieve a plateau
(for example: young children with high elastic recoil, patients with restrictive lung
disease or patient with neuromuscular disease).
If performing inspiratory loops, the forced inspiratory vital capacity (FIVC) should not
be larger than the FVC as this would indicate that the FVC has been underestimated
(FIVC minus FVC ≤0.100 L or 5% of FVC, whichever is greater)1
How to ensure repeatability between individual spirograms
After three acceptable spirograms have been obtained, the following checks are used to
assess for repeatability:
- The two largest values of FEV1 must be within 0.150 L of each other.
- oral therapy with Aminophylline or slow release β agonist should be withheld for
12 hours 5 .
• If the aim of the test is to determine whether the patient’s lung function can
be improved with therapy in addition to their regular treatment, then regular
medication as prescribed can be continued.
Administration of bronchodilators
• FEV1 and FVC should be reported in litres (L) to two decimal places.
• The largest FVC and largest FEV1from acceptable and repeatable manoeuvres are
reported, even though the values may not come from the same manoeuvre.
• The largest VC from at least two acceptable and repeatable manoeuvres is reported.
• The largest peak flow from an acceptable and repeatable manoeuvre should be
reported in litres per second (L/s) to two decimal places.
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• All other flows, if required by the requesting medical officer, are reported from the
“best” test. The “best” test is defined as the manoeuvre with the largest sum of FVC
and FEV1.
• Expiratory and inspiratory flow-volume curves from different acceptable efforts may
be combined to produce a flow-volume loop.
• In paediatrics1, 6:
̵ GLI reference values for FEV0.75 are available for children aged 3-7 years of age
̵ for children aged 7 years or younger, FEV0.75 should be reported.
• Note: Test results that do not meet acceptability, repeatability and usability criteria
may still provide useful clinical information. It is important to make note of the
reasons in the report technical comments and advise to interpret with care.
5. Definitions
Term Definition / Explanation / Details Source
Acceptability Criteria Satisfactory start, middle and end of test conditions 5
maximal inhalation
FEV1 (L) The forced expiratory volume in t seconds, litres (L)
12
The maximal volume of air expired by Time (t seconds) from
Time 0 of a forced expiratory manoeuvre.
FEV0.5 Forced expiratory volume in 0.5 second, litres (L)
1
The maximal volume of air exhaled in the first 0.5 seconds of
a forced expiration from a position of full inspiration
FEV0.75 Forced expiratory volume in 0.75 seconds, litres (L)
The maximal volume of air exhaled in the first 0.75 seconds 1
Approval officer
Deputy Director General Clinical Excellence Queensland
Version control
Version Date Comments
1.0 2021 New document replaces previous guidelines Spirometry: adult
and Spirometry: paediatric. Guidelines condensed and updated
following the release of “Standardization of Spirometry 2019
Update. An Official American Thoracic Society and European
Respiratory Society Technical Statement” in 2019.
Suggested resources
o For indigenous health workers within Queensland, there is an Indigenous Respiratory Outreach
Care (IROC) Spirometry training program
References
1. Graham, B.L., et al., Standardization of Spirometry 2019 Update. An Official American Thoracic
Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med, 2019.
200(8): p. e70-e88.
2. Queensland Health Informed decision making in health care. 2012.
3. National Health and Medical Research Council. Australian Guidelines for the Prevention and Control
of Infection in Healthcare. 2019 [cited 2020 23/06/2020]; CD33:[Available from:
https://nhmrc.govcms.gov.au/about-us/publications/australian-guidelines-prevention-and-control-
infection-healthcare-2019#block-views-block-file-attachments-content-block-1.
4. Miller, M.R., et al., General considerations for lung function testing. Eur Respir J, 2005. 26(1): p. 153-
61.
5. Miller, M.R., et al., Standardisation of spirometry. Eur Respir J, 2005. 26(2): p. 319-38.
6. Beydon, N., et al., An official American Thoracic Society/European Respiratory Society statement:
pulmonary function testing in preschool children. American Journal of Respiratory & Critical Care
Medicine, 2007. 175(12): p. 1304-45.
7. Gauld, L.M., et al., Height prediction from ulna length. Dev Med Child Neurol, 2004. 46(7): p. 475-80.
8. Monash Centre for Occupational and Environmental Health School of Public Health & Preventive
Medicine Faculty of Medicine, N.a.H.S.M.U., Review of Respiratory Component of the Coal Mine
Workers’ Health Scheme for the Queensland Department of Natural Resources and Mines. 2016,
Monash University & University of Illinois: Melbourne. p. 116.
9. Quality Innovation Performance Limited. Coal Mine Workers' Health Scheme. Spirometry Training
Course Provider Accreditation 2020 [cited 2020 26/02/2020]; Details regarding the accreditation
process for spirometry training courses]. Available from: https://www.qip.com.au/spirometry-
training-course-accreditation/.
Spirometry guideline – Queensland Health Guideline Page 18
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10. Swanney, M.P., et al., Spirometry training courses: Content, delivery and assessment - a position
statement from the Australian and New Zealand Society of Respiratory Science. Respirology, 2017.
22(7): p. 1430-1435.
11. Quanjer, P.H., et al., Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global
lung function 2012 equations. Eur Respir J, 2012. 40(6): p. 1324-43.
12. American Thoracic Society, Pulmonary Function Laboratory Management and Procedure Manual.
2nd ed, ed. J. Wanger, R. Crapo, and C. Irvin. 2005: American Thoracic Society.
13. Service, Q.H.I., Working with Interpreters Guidelines, Q. Health, Editor. 2007, Queensland Health
Electronic Publishing Service: Queensland. p. 38.
14. Australian Commission on Safety and Quality in Health Care Safety and Quality Improvement Guide
Standard 5: Patient Identification and Procedure Matching (October 2012). 2012, ACSQHC: Sydney.
15. Pesant, C., et al., Spirometric pulmonary function in 3- to 5-year-old children. Pediatric Pulmonology,
2007. 42(3): p. 263-71.
16. Enright, P.L., et al., Quality of spirometry test performance in children and adolescents : experience
in a large field study. Chest, 2000. 118(3): p. 665-71.
17. Allied Health Professions' Office of Queensland, Changes to scheduled medicine authorities –
Respiratory Scientists, Q. Health, Editor. 2018, Queensland Health: Queensland.
18. Pellegrino, R., et al., Interpretative strategies for lung function tests. Eur Respir J, 2005. 26(5): p. 948-
68.
19. Culver, B.H., et al., Recommendations for a Standardized Pulmonary Function Report. An Official
American Thoracic Society Technical Statement. Am J Respir Crit Care Med, 2017. 196(11): p. 1463-
1472.
20. Wanger, J., et al., Standardisation of the measurement of lung volumes. European Respiratory
Journal, 2005. 26(3): p. 511-22.
21. Wanger, J., et al., Standardisation of the measurement of lung volumes. Eur Respir J, 2005. 26(3): p.
511-22.
22. American Thoracic Society, Pulmonary Function Laboratory Management and Procedures Manual.
1st ed. 1994: American Thoracic Society.
23. Cotes, J.E., D.J. Chinn, and M.R. Miller, Lung Function Physiology, Measurement and Application in
Medicine. 6th ed. 2006: Blackwell Publishing.
24. Gauld, L.M., et al., Prediction of childhood pulmonary function using ulna length. Am J Respir Crit
Care Med, 2003. 168(7): p. 804-9.
25. Quanjer, P.H., et al., All-age relationship between arm span and height in different ethnic groups. Eur
Respir J, 2014. 44(4): p. 905-12.
26. Wainwright, C.E., et al., Cough-generated aerosols of Pseudomonas aeruginosa and other Gram-
negative bacteria from patients with cystic fibrosis. Thorax, 2009. 64(11): p. 926-31.
27. Johns, D. and R. Pierce, Pocket Guide to Spirometry. 2nd ed. 2007: McGraw-Hill Australia.
Standard precautions must always be followed. Disease prevention or cross contamination can be
prevented by considering the following infection prevention measures:
• Single patient use disposable in-line filters integrated with mouthpieces are now standard
practice in many health care settings. They are an effective and less expensive method of
preventing equipment contamination.
• In-line filters have been shown to remove microorganisms from the expiratory air stream
and thus prevent their deposition as aerosol nuclei on spirometer surfaces.
• Many filters have a stated bacterial reduction efficiency of 99.7% at a flow rate of 750
L/min, i.e. they are designed for use during lung function testing with low resistance at
high flow rates yet retaining high filtration performance. That equates to a bi-directional
efficiency of 99.997%.
• The use of in-line filters does not eliminate the need for regular cleaning and
decontamination of lung function equipment.
• When using equipment with inspiratory and expiratory manoeuvres, in-line bacterial viral
filters must be used and disposed of after every patient (single patient use).
The ATS/ERS1 22 recommends extra precautions are taken for patients with known transmissible
infectious diseases:
The use of single patient use disposable in-line filters is strongly recommended for all spirometer types,
particularly as the accuracy of the spirometer could be affected by droplet deposition on flow sensors if
one-way valve mouthpieces are used
Disability/impairment evaluations:
• A child friendly pulmonary function laboratory is of the utmost importance. Young children
need to feel comfortable in the laboratory environment if they are to perform spirometry well.
The operator has a significant impact on the comfort level of the child 6. This type of
environment may be achieved through a combination of friendly conversation, songs, or
through distraction with a videotape, book, interactive computer game, toy or puzzle.
• Designated rooms may help to prevent distraction in children during testing.
• Ensure clearly defined rooms are available for spirometry testing, particularly for patients with
confirmed or suspected communicable diseases, and immuno-compromised patients. Specific
infection control procedures pertaining to spirometry testing are outlined in Appendix 1.
• Allow adequate space for chairs, wheelchairs, and prams for the child and accompanying
adult(s), and accommodation for staff who may require mobility assistance.
Spirometer
• Ensure the spirometer’s graphic display permits visual inspection of the flow–volume and
volume–time curves essential for quality control. Preschool children are less likely to produce
technically adequate expirations than older children and are likely to become bored or tired if
the test session is prolonged unnecessarily. It is therefore advantageous if the operator and the
child can visualize these curves onscreen, or at least before the next effort.
• Set the display to include FVC, FEVt, time to PEF (PEFT), BEV (back-extrapolation volume) and
the point at which flow ceases, presented as a proportion of PEF. Timed volumes displayed for
pre-schoolers should include FEV0.5 or FEV0.75 and FEV1. Review these measurements before the
next effort and encourage the child to alter his or her technique if necessary 6.
• Paediatric spirometry software equipment may include animated incentives intended for both
pre-schoolers and older children. These incentives are designed to encourage rapid and
prolonged expiration 6. Incentives that encourage tidal breathing and maximal inspiration may
also be helpful. Use these visual incentives discretionally as they may distract some children.
• Spirometers for use in preschool patients must be capable of measuring instantaneous flows
with an accuracy of at least ± 5% 6. Dead space should be minimized where possible, although
this requirement does not preclude the use of bacterial filters. Otherwise, recommendations
for equipment for use in adult subjects apply6.
1. The pneumotachometer measures flow by using a differential pressure flow sensor, which consists of
a tube containing a resistive element. The resistive element allows gas to flow through it but
causes a pressure drop. The pressure drop across the resistive element is measured by means of a
sensitive pressure transducer, with pressure taps on either side of the element, and is proportional
to the flow rate of gas if the flow is laminar (not turbulent). In some systems the resistive element
is heated, which prevents accumulation of moisture from exhaled gas on the element.
2. The ultrasonic flow sensor measures flow using ultrasonic pulses travelling in opposite directions at
an angle to the air flow. The speed at which the pulses travel is dependent on the air flow rate and
direction and can be determined from the time the pulses take to travel from one side to the
other. The flow rate is thus determined from the pulse transit times.
3. The hot-wire flow sensor (anemometer, mass-flow sensor) contains a heated wire (or wires). As air
flows past the wire it is cooled, with the degree of cooling dependent on the air flow rate. The air
flow rate is proportional to the amount of electrical current required to keep the wire heated,
which depends on the mass of air flowing over the wire.
4. The rotating vane flow sensor (turbine type) has a very light vane which spins when air flows past.
The rotating vane interrupts the light path between a light source and photocell, causing pulses at
the photocell. The air flow rate is proportional to frequency of these pulses.
The measurement is made using a stadiometer, leaving both hands free to position the subject whilst
measuring height. Measure and record the patient’s height (barefoot) in centimetres (to the nearest
0.1 cm), without shoes, feet together, heels against the wall, standing as tall and straight as possible
and with the head in the Frankfort horizontal plane: 23
• Instruct patient to place heels together and stand as tall as possible with the heels, calf,
buttocks and back preferably touching the stadiometer.
• Once the patient is in this position cup the angles of the mandible in both hands, tilt the
patient’s face so that the lower orbital margin (eye socket) is level with the external auditory
meatus (ear canal). This is the Frankfort Plane (see Figure 1).
• Gently apply upward lifting pressure to the mastoid processes, to elongate the vertebral
column.
• If measuring a child, instruct the child to inhale deeply, and “stretch tall” whilst the
measurement is made.
• Measure and record the height to the nearest centimetre in adults and 1 millimetre in children.
Note: Compared with subjects who are standing erect but unsupported this procedure can
increase the apparent height by up to 5 cm. It can also eliminate diurnal variation and improve
the reproducibility, which is then less than 2 mm. Note: In paediatric patients, where accurate
height measurements are not able to be obtained (e.g. scoliosis), then ulna length should be
measured using Harpenden callipers7, and the estimated standing height then used in
pulmonary function prediction equations (see below)24, 25
Figure 1. Measurement of stature showing the effects of moving the head into the Frankfort plane (short dashed line at eye level), and
then applying traction. The same method is also used for accurate height measurement in adults. (Diagram supplied courtesy of Barry
Dean, Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston QLD, 4029).
Measurement of ulna length and its use in estimating standing height and predicting lung function
• The ulna length is obtained by seating the child with the forearm resting comfortably on a flat
surface. Place the palm downwards with the fingers extended and together. The elbow is bent
at 90o to 110o. The proximal end of the ulna is found by palpating along its length. The tip of the
styloid process is felt at the wrist (Figure 2) by palpating down the length of the bone distally
until its end is felt. The tips of the anthropometer (Harpenden Calliper) are placed adjacent to
both end points, and the ulna length(U) is measured in cm to one decimal place (Figure 3).
• Use in calculating standing height: standing height can be estimated from measured ulna
length (U) using the equations of Gauld7. The estimated height can then be used to predict FEV1
and FVC based on current recommended GLI reference equations11.
• Use in predicting lung function: Having measured the ulna length (U), a prediction of FEV1,
FVC and FEF25-75% can be based on the published reference values and equations of Gauld24.
To have confidence in the data that is generated during spirometry testing, the spirometer must be
regularly validated for volume and linearity. Depending on the type of spirometer used, these
parameters need regular calibration, whereas some only require calibration verification.
Calibration syringe 12
• The calibration syringe should be stored at the same temperature and humidity as the testing site,
away from direct sunlight and heat sources. This is best achieved by storing the syringe close to
the spirometer. Holding the syringe body to steady it during calibration can raise its temperature
and contribute to measurement error.
• A calibration syringe should be used to check the volume calibration of spirometers and must
have an accuracy of ±15mL or 0.5% of the full scale, whichever is greater. For most spirometers
the syringe volume required is 3L.
• A calibration syringe should be validated yearly to ensure accuracy. For specific details refer to the
manufacturer’s recommendations.
• A calibration syringe should be checked monthly for leaks by attempting to empty it with the
outlet occluded. This should be performed at more than one volume.
• Perform regular inspection of adjustable or variable stops, if they exist. A dropped or damaged
syringe should be considered out of calibration until it is checked.
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• Use of the syringe on many machines distinguishes between instrument problems and problems
with the syringe.
• Calibration is the procedure for establishing the relationship between the flow or volume
measured by the sensor and the actual flow or volume of the calibration syringe.
• Volume calibration should be performed at least daily, or after every 10 patients in a busy
service. 2
• Recalibration may be indicated and BTPS correction factors updated if the testing environment
temperature changes. 4
• In-line bacterial-viral respiratory filters must be in place during calibration if they are used during
testing. 5
• Some portable spirometers are calibrated by the manufacturer and only require a daily calibration
verification (also known as calibration check, calibration verification). Check manufacturer’s
guidelines.
• A new calibration or equipment maintenance by the manufacturer is required if a device fails its
calibration verification. Check manufacturer’s guidelines for trouble shooting advice.
Calibration verification
• Calibration verification ensures that the spirometer is within calibration limits (+/-3% of the true
volume, 3 L where a 3 L syringe is used; +/-2.5% for the spirometer and +/-0.5% for calibration
syringes 1 ).
• Calibration verification should be performed at least daily or after each calibration or after every
10 patients in a busy service. 2
• Re-verification may be indicated and BTPS correction factors updated if the testing environment
temperature changes. 4
• In-line bacterial-viral respiratory filters must be in place during the calibration verification if they
are used during testing. 5
Procedure for calibration verification 5
• Perform calibration verification at least daily with a 3L syringe. Check manufacturer’s guidelines for
details.
• A 3.00 L syringe should be injected at three different flow rates between 2 and 12 L/s (with 3 L
injection times of ~6 second and < 0.5 second); minimum volume accuracy should be within 3% at
all flows.
• For spirometers that use disposable flow sensors, a new unused sensor should be tested daily.
• A flow linearity check of pneumotachs weekly ensures that minimum volume accuracy is met for
the entire range of flows measured (low-, mid-, high-flows). If the spirometer meets volume
accuracy requirements of ±3% for all flow rates tested then it meets the requirements for linearity.
A biological control is a healthy, non-smoking individual, usually a staff member, that is regularly tested
and becomes the reference standard for the biological control program. A biological control procedure
does not replace regular syringe calibration and calibration verification procedure. Biological control
testing is a requirement for occupation health screening for the Coal Mine Workers Health Scheme
(CMWHS). It is recommended to have more than one biological control.
Biological controls must initially be “characterised” according to the “gold standard” testing procedures
before the data becomes the “reference standard”. The biological control’s lung function must be
measured as accurately as possible under ideal conditions to determine a baseline value. All
subsequent testing of the biological control is compared to this baseline value. Characterisation
determines the variability of the biological control under the most ideal conditions. As normal lung
function deteriorates with age, it is important to check biological data periodically.
Characterisation requires that:
• FEV1, VC, FVC volumes are measured according to ATS/ERS guidelines for acceptability and
repeatability. 1, 5
• The subject is free of symptoms or known respiratory disease that may cause variability in lung
function results.
• Data is collected at least 10 times over a 1 to 2 week period under the above conditions to assess
variability of the individual’s data.
• The mean for each measured parameter becomes the reference standard or the “correct value”.
Biological control data analysis
Day to day variations in physiological function of the biological control occur even under ideal testing
conditions. The variability is used to set the “control limits for the test”, and allows identification of
data that is “out of control”, and is determined by the following steps:
• the mean value during gold standard testing is the “correct value” for the biological control
• the standard deviation can now be used to set the control limits, where mean ± 1.96 x SD gives a
confidence interval of 95%, this means that approximately 95% of the values will be between ±
2SD of the mean
• The biological control results, collected on a regular basis, can be plotted on a Levy-Jennings plot
(see Graph 1) and interpreted using the Westgard rules. Westgard rules can be used to define
specific limits for biological control results when compared with the “gold standard” testing
results and to help determine if quality assurance responses need to be enacted, as follows: 12
̵ when one control observation exceeds the mean ±2 SD, a "warning" condition exists
̵ when one control observation exceeds the mean ±3 SD, an "out of control" condition exists
̵ when two consecutive control observations exceed ±2 SD, an "out of control" condition exists
values between 2 and 3 SD limits indicate an error and the procedure should be repeated
values beyond ±3 SD are considered unacceptable and the testing system should be
evaluated.
To determine the back-extrapolation volume a line is constructed through the steepest part of the
volume–time curve (Figure 1). Where this line crosses the time axis is the new “time zero”, from which
all timed volumes (such as FEV1 ) are measured. The back-extrapolation volume is the volume on the
spirogram at the new “time zero”. To render a spirogram acceptable the back-extrapolation volume
must be less than 5% of the FVC or 0.100 L, whichever is greater1 .
Figure 5. An expanded version of the early part of a volume-time spirogram, with a back-extrapolation line through the steepest part of
the curve to determine the new time zero at ~ 0.21 seconds. The back-extrapolation volume is 0.09 L (determined by volume expired at
new time zero). If the FVC is 4.18 L then EV is 2.1% FVC. 5, 22
Figure 6. Examples of unacceptable volume-time spirometry results compared with good efforts 26
Figure 7. Examples of unacceptable flow-volume spirometry loops compared with an acceptable effort 27