Pulmonary Function Laboratory ATS Accreditation Are you prepared? Susan Blonshine RRT, RPFT, FAARC, AE-C

Pulmonary Function Laboratory ATS Accreditation Are you prepared? Susan Blonshine RRT, RPFT, FAARC, AE-C

Why Quality Consistent, accurate, reliable results Cost-effective Diagnosis Misclassification Reduce or eliminate medical errors Meeting customer requirements Required for successful governmental, certification or accreditation assessments 2

ERS 2012 3

ATS Pulmonary Function Laboratory Management and Procedure Manual, 3rd Edition. 4

ATS PF Lab Voluntary Accreditation Program ATS Management and Procedure Manual Basis for accreditation program PF Lab Registry is available on-line 5 years with purchase of Manual (code is supplied) First step to be started in the process Less than 100 sites currently 5

ATS PF Lab Voluntary Accreditation Program Pre-assessment checklist completed Based on the ATS PF Lab Manual Beta testing in 2018 in 5 PF labs 2019 program expansion Mentoring/Coaching support available to labs Committee focused on education and success for the PF Labs 6

Checklist - Personnel 7

Checklist General Considerations 8

Checklist Facilities, Hygiene, Safety 9

Checklist - Facilities, Hygiene, Safety 10

Checklist - QC 11

Test Method Biologic QC Mechanical QC Frequency Spirometry monthly Linearity check weekly DLCO weekly Syringe DLCO weekly DLCO Gas analyzer linearity check (e.g. DLCO simulation or other syringe dilution method) monthly Plehysmography Lung Volumes monthly Isothermal bottle Airway Resistance monthly Helium Dilution monthly Nitrogen Washout monthly Exercise with Gas Exchange monthly Treadmill Check slope and speed monthly Lung Clearance Index monthly 12

Checklist Equipment and QC 13

Checklist - QC 14

Other Requirements BioQC Range Update Schedule Instructions how to perform each QC method Training on QC Procedures Competence Assessment Out of Control Process Troubleshooting Documentation 15

Exercise Quality Control Components Technologist training/oversight Equipment maintenance Components Calibration Mechanical quality control Physiologic quality control 16

Equipment QC Recordkeeping Records Manual Table of Contents Instructions for Manual Use Quality Control Plan Temperature Correction Table Calibration Reports Quality Control Log Syringe Quality Control (linearity and DLCO) Biologic Summary Reports (SD and means for each biologic standard) Biologic QC 1 and QC 2 DLCO Simulator Documentation or DLCO linearity testing, instructions, worksheets, logs Gas Analysis Certificates Maintenance and Troubleshooting Log 17

Checklist Spirometry with dilator 18

Checklist Lung Volumes 19

Checklist - Lung Volumes Equipment preparation and calibration Patient preparation Testing procedure Reporting results 20

Checklist Airway resistance chapter 9 DLCO chapter 10 (2017) Maximal muscle pressures chapter 11 Methacholine challenge testing chapter 12 Includes personnel requirements 21

Checklist Exercise Testing Exercise challenge for bronchospasm chapter 14 Exercise for desaturation evaluation chapter 17 Field tests; six minute walk chapter 18 Cardiopulmonary exercise chapter 19 22

Checklist - Interpretation 23

Checklist Reference Equations 24

Checklist Reference Equations 25

Process and Contacts Specific documentation will be requested by the on-site inspection team A call may be scheduled prior to the visit 26

Test Quality Review Technologist Expectations

Test Quality Checklist Spirometry Was the ATS/ERS end of test criteria met? (1 second plateau) Was the expiratory time at least 6 seconds? Was the back extrapolated volume less than 5% of the FVC or 150 ml, whichever is greater? Is exhalation smooth and continuous? Was the effort maximal based on the peak flow? Have 3 acceptable trials been completed? Was repeatability criteria met for FVC and FEV1 (150 ml)? 28

Test Quality Checklist - DLCO 29

Test Quality Checklist Lung Volumes Was the EELV stable? Was the shutter closed at the correct level? Was the pant volume small (i.e. <50mL) Was the Pant frequency ~ 1Hz (30-60/m) for TGV Was the loop closed with the TGV Maneuver? Is there minimal hysteresis in the open shutter loop? Are there at least 3 acceptable trials? Has repeatability criteria been met? 30

Test Quality Checklist Airway Resistance Was the Pant frequency ~1-2 Hz (90-120/m) for Raw? Was the loop closed with the Vpant Maneuver? Is there minimal hysteresis in the open shutter loop? Is the pant volume acceptable? Are there at least 3 acceptable trials? Has repeatability criteria been met? 31

Reporting Results Grading Test Quality 32

Any Questions? Susan Blonshine BS, RRT, RPFT, FAARC, AE-C TechEd Consultants, Inc. www.techedconsultants.com sblonshine@techedconsultants.com 33