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Standards for Spirometry Training Courses Companion Document to Standards for the Delivery of Spirometry for Coal Mine Workers Thoracic Society of Australia and New Zealand June 2017 Developed in partnership with

Contents Glossary... ii Background... 1 Introduction... 1 1. Core components of a Spirometry Training course... 2 1.1 Overview of Spirometry... 2 1.2 Personnel... 2 1.3. Equipment management, including calibration and quality control... 2 1.4. Infection control and Medical Emergencies... 3 1.5 Conducting the Test/Measurement... 3 Step 1. Determine the test indication and any contraindications... 3 Step 2: Equipment preparation... 3 Step 3: Worker preparation... 3 Step 4: Conducting the Test... 4 Steps 5 & 6: Finalising the Test and Operator Comment... 4 1.6. Interpretation and Reporting... 4 2. Course delivery modes... 4 3. Course duration... 5 4. Frequency of refresher training... 5 5. Qualifications and staff ratios of course providers... 5 6. Assessment Requirements... 5 Evaluation of Compliance with this Standard... 6 References... 7 Glossary ANZSRS ATS BTPS CRFS ERS FEV 1 FVC LABA SABA TSANZ Definition WORKER Australian and New Zealand Society of Respiratory Science American Thoracic Society Body temperature, ambient pressure saturated with water vapour Certified Respiratory Function Scientist European Respiratory Society Forced Expiratory Volume in one second Forced Vital Capacity Long-acting Beta Agonist Short-acting Beta Agonist Thoracic Society of Australia and New Zealand A coal mine worker presenting for a health assessment ii

Background This document has been developed to accompany the TSANZ Standards for Delivery of Spirometry for Coal Mine Workers 5. The completion by spirometry operators of a spirometry training course that meets this standard is required in order to achieve compliance with the Standards for Delivery. This document draws on the best evidence and is consistent with the recommendations of both TSANZ and ANZSRS with respect to minimum requirements for training in spirometry 1. As a minimum, spirometry training course content must adhere to the current international ATS/ERS pulmonary function standards for general considerations for lung function testing 2 spirometry testing 3 and interpretation 4. Introduction An independent review of the respiratory component of the Coal Mine Workers Health Scheme 6 (the Scheme) was undertaken by Monash University in response to the re-emergence of black lung in Queensland. The review was published in July 2016 and, with respect to spirometry testing, concluded that: Overall, the reported quality control and assurance of spirometry testing needs to be improved. For example, although 79% of spirometers were reported to have had a calibration check, most (66%) had not been calibrated in 2016. This is a significant inadequacy considering devices used in the study require daily calibration checks. a majority of the spirometry performed under the scheme is likely to be of poor quality and more ongoing training and quality assurance is needed to reach accepted standards. 6 This document defines: 1 Core components of spirometry training under the following headings: 1.1 Overview of spirometry 1.2 Personnel 1.3 Equipment management, including calibration and quality control 1.4 Infection Prevention 1.5 Conducting the Test/Measurement 1.6 Interpretation and reporting 1.7 Troubleshooting 1.8 Record keeping 2. Course delivery modes 3. Course duration 4. Frequency of refresher training 5. Qualifications of course convenors and faculty 6. Faculty ratios 7. Assessment 1

1. Core components of a Spirometry Training course 1.1 Overview of Spirometry Operators are required to understand the purpose of spirometry and to be aware of relevant best practice standards. Training must include: An explanation of what spirometry is with reference to the ATS/ERS standards for general considerations for lung function testing 2, spirometry testing 3 and interpretation 4 Definitions of spirometric indices (e.g. FEV 1, FVC, FEV 1 /FVC) Understanding volume time and flow volume curves Explanation of BTPS conditions for reported values Understanding reference values including definitions the use of the lower limit of normal and percent predicted limitations of reference equations and the importance of ethnicity 1.2 Personnel Training providers will provide participants with a log book for recording spirometry. 1.3. Equipment management, including calibration and quality control Training will ensure the following items are addressed: Minimum requirements for spirometers that meet ATS/ERS standards 3 including performance requirements, calibration procedures, reporting reference values and values expressed in BTPS conditions 3,4 Calibration and verification definitions Frequency of calibration and/or verification Spirometer accuracy in accordance with ATS/ERS standards, using a calibrated, certified 3 L syringe at variable flows 3 Preventative maintenance Conducting biological controls Managing new software versions Trouble shooting equipment 2

Training must ensure that participants are able to develop and maintain an equipment maintenance log that includes: Equipment history with noted use and any changes in hardware, software and prediction equations Equipment calibration and verification records, including error reports and resulting preventative maintenance Biological control record and calculated normal ranges 1.4. Infection Prevention and Medical Emergencies Training must address infection prevention and management of medical emergencies or adverse events arising from spirometry. The training must include the following components: Regular equipment cleaning Hand-washing hygiene between workers and following equipment handling Single-use versus reusable consumables Use of viral/bacterial filters and spacers Use of personal protective equipment (e.g. gloves) Understanding local protocols for medical emergency management Understanding of management of the infectious worker 1.5 Conducting the Test/Measurement The training should cover all steps set out in the Standard 5 as follows: Step 1. Determine the test indication and any contraindications Pre-appointment instructions relating to the use of SABA or LABA Indications and contraindications to testing Management of communicable disease Step 2: Equipment preparation Checking equipment is correctly set up and calibrated/accuracy check is conducted where required. Attachment of mouthpieces and/or filters Step 3: Worker preparation Importance of accurate recording of worker s height, weight, age, gender and ethnicity Worker posture during testing How to explain and demonstrate the test 3

Step 4: Conducting the Test Performance of the test as per the ATS/ERS standards for spirometry 3 Acceptability and repeatability criteria 3 Identifying manoeuvres that meet acceptability and repeatability criteria Reversibility assessment including choice of bronchodilator, withholding times, method of administration and time to peak efficacy Troubleshooting instrument errors Troubleshooting worker manoeuvres to achieve acceptability and reproducibility criteria and identifying common causes of unacceptable manoeuvres Steps 5 & 6: Finalising the Test and Operator Comment When testing is complete in terms of maximum number of test attempts or when acceptability and repeatability criteria are achieved 3 Selection of suitable reference equations Selection of best test data for reporting purposes Technical comments to describe test quality 1.6. Interpretation and Reporting Quality of test statement Algorithm for interpretation in the Standard 5 including: Pattern recognition: Normal; Obstructive; or Restrictive pattern Assessing severity of obstruction Bronchodilator response Longitudinal monitoring Limitations of spirometry - when other tests may be required or referral pathways Reporting and storing results 2. Course delivery modes Spirometry training courses may be face to face or a mixture of e-learning knowledge modules combined with face to face practical modules. Purely online delivery is not acceptable as it does not allow for hands on practical training. 4

3. Course duration For face to face delivery, a minimum of 10 hours training is required, of which at least 60 percent must be practical hands on training. For mixed delivery methods, in addition to e-learning modules which can be completed at the trainee s own pace, at least six hours of practical face to face training is required. 4. Frequency of refresher training It is important to note that there is strong evidence that the quality of spirometry improves with regular performance of the procedure and where operators have access to ongoing support and feedback after completion of training. Refresher training ensures that operators remain abreast of changes in technology and research in the field. A one day refresher course must be attended twelve months after the successful completion of the initial training course and then completion of an additional one day refresher course is required every three years thereafter. Refresher courses should be tailored to review the content of this document with participants and focus on practical skills. As such the course will be one day in duration (eight hours of training) and should be approximately 50 percent theoretical review with updates to standards and best practice as required and 50 percent practical. 5. Qualifications and staff ratios of course providers Spirometry training courses should be co-ordinated and run by a suitably respiratory qualified person(s) with substantial experience in the theoretical and practical aspects of spirometry measurement and interpretation. The onus is on the provider to demonstrate this to the accrediting body. A Respiratory Scientist who has passed the Certified Respiratory Function Scientist (CRFS) examination and has at least five years of experience in a TSANZ accredited respiratory function laboratory would meet these criteria. At least one qualified staff member is available for every five trainees during the practical components. 6. Assessment Requirements Assessment should comprise of direct observation of the conduct of spirometry as well as a pass mark in the theoretical components. Post course assessment in the workplace is also required before a trainee can complete the course. This assessment should be both theoretical and practical and will include completion of at least ten spirometry tests in the workplace for review by the course provider. A certificate of completion may only be issued when the participant has correctly completed workplace spirometry tests and has completed the theoretical assessment. The course provider is required to provide participants with a Certificate of Completion and to maintain records of participant enrolment and completion of both initial and refresher training. 5

Evaluation of Compliance with this Standard Training providers will demonstrate compliance with this standard as follows: The core components of spirometry training will address the mandatory content detailed in this document. Participants will be provided with a log book to record their spirometry practice in the workplace (proformas are available from TSANZ). Training must be structured to cover the mandatory components and may be delivered either as 1: a minimum of 10 hours face to face of which at least 6 hours must be practical, or 2: online delivery for the theoretical component and at least 6 hours of face to face practical. Refresher training program will address updates to standards and provide a practical refresher. The refresher training will be 50 percent practical and 50 percent theoretical. The provider must demonstrate that the course is being delivered by a suitably respiratory qualified person with substantial experience in the theoretical and practical aspects of spirometry measurement and interpretation. At least one qualified staff member is available for every five trainees during the practical components. Post course assessment in the workplace is required and will comprise of theoretical assessment and at least ten correctly performed spirometry. 6

References 1. Spirometry Training Committee, Australian and New Zealand Society of Respiratory Science and The Thoracic Society of Australia and New Zealand. February 2004. Available from: http://www.anzsrs. org.au/index.php/about/position-statements/send/11-position-statements/175-spirometry-trainingposition-statement Date last accessed 29/11/2016 2. ATS/ERS Task Force. Standardisation of lung function testing: General considerations for lung function testing. Eur Respir J 2005; 26: 153-161 3. ATS/ERS Task Force. Standardisation of lung function testing: Standardisation of spirometry. Eur Respir J 2005; 26: 319-338. 4. ATS/ERS Task Force. Standardisation of lung function testing: Interpretive strategies for lung function testing. Eur Respir J 2005; 26: 948-968. 5. Thoracic Society of Australia and New Zealand. 2017. Standards for the Delivery of Spirometry for Coal Mine Workers. 6. Monash Centre for Occupational and Environmental Health. 2016. Review of Respiratory Component of the Coal Mine Workers Health Scheme for the Queensland Department of Natural Resources and Mines. Accessed at https://www.dnrm.qld.gov.au/ data/assets/pdf_file/0009/383940/monash-qcwpfinal-report-2016.pdf 7

The Thoracic Society of Australia and New Zealand Ltd Suite 405, Level 4, 5 Hunter Street, Sydney NSW 2000 P +61 2 9222 6200 F +61 2 9221 0438 E info@thoracic.org.au www.thoracic.org.au