1. Quality Improvement Put into Practice Carl Mottram, BA RRT RPFT FAARC Director - Pulmonary Function Labs & Rehabilitation Assistant Professor of Medicine - Mayo Clinic College of Medicine Carl Mottram, BA RRT RPFT FAARC Director - Pulmonary Function Labs & Rehabilitation Assistant Professor of Medicine - Mayo Clinic College of Medicine

2. Case Presentation 31 y.o. female 31 y.o. female History of present illness History of present illness Non-specific cough, tightness in throat and episodic shortness of breath following URI Non-specific cough, tightness in throat and episodic shortness of breath following URI No wheezing noted by patient or on exam No wheezing noted by patient or on exam Exam normal other than obesity (BMI 38) Exam normal other than obesity (BMI 38) LMD orders CXR and spirometry with diffusing capacity LMD orders CXR and spirometry with diffusing capacity 31 y.o. female 31 y.o. female History of present illness History of present illness Non-specific cough, tightness in throat and episodic shortness of breath following URI Non-specific cough, tightness in throat and episodic shortness of breath following URI No wheezing noted by patient or on exam No wheezing noted by patient or on exam Exam normal other than obesity (BMI 38) Exam normal other than obesity (BMI 38) LMD orders CXR and spirometry with diffusing capacity LMD orders CXR and spirometry with diffusing capacity

3. Case Presentation CXR CXR Spirometry & DLCO Spirometry & DLCO PrePostPred FVC 2.102.1162% FEV 1 0.891.3631% Ratio42.464.5 DLCO8.030% Impression: Severe obstruction with a severe reduction in DLCO. Some improvement with BD CXR CXR Spirometry & DLCO Spirometry & DLCO PrePostPred FVC 2.102.1162% FEV 1 0.891.3631% Ratio42.464.5 DLCO8.030% Impression: Severe obstruction with a severe reduction in DLCO. Some improvement with BD

4. Case Presentation LMD Action Plan LMD Action Plan Orders a CT scan Orders a CT scan Referred to Mayo Clinic for further evaluation Referred to Mayo Clinic for further evaluation LMD Action Plan LMD Action Plan Orders a CT scan Orders a CT scan Referred to Mayo Clinic for further evaluation Referred to Mayo Clinic for further evaluation

5. Case Presentation Outside CT negative Outside CT negative Pulmonary, ENT, and GI consults scheduled Pulmonary, ENT, and GI consults scheduled Pulmonary physician Pulmonary physician Negative exam Negative exam Lungs clear, patient had coughing spell during exam, no wheezing or stridor noted Lungs clear, patient had coughing spell during exam, no wheezing or stridor noted Questioned outside spirometry results and orders PFT’s Questioned outside spirometry results and orders PFT’s Outside CT negative Outside CT negative Pulmonary, ENT, and GI consults scheduled Pulmonary, ENT, and GI consults scheduled Pulmonary physician Pulmonary physician Negative exam Negative exam Lungs clear, patient had coughing spell during exam, no wheezing or stridor noted Lungs clear, patient had coughing spell during exam, no wheezing or stridor noted Questioned outside spirometry results and orders PFT’s Questioned outside spirometry results and orders PFT’s

6. Case Presentation Spirometry & DLCO Spirometry & DLCO PrePostPred FVC2.552.4875% FEV12.272.2579% Ratio8990.7 DLCO24.299% Impression: Borderline restriction most likely 2  to obesity with no evidence of airflow obstruction or BD response Impression: Borderline restriction most likely 2  to obesity with no evidence of airflow obstruction or BD response Spirometry & DLCO Spirometry & DLCO PrePostPred FVC2.552.4875% FEV12.272.2579% Ratio8990.7 DLCO24.299% Impression: Borderline restriction most likely 2  to obesity with no evidence of airflow obstruction or BD response Impression: Borderline restriction most likely 2  to obesity with no evidence of airflow obstruction or BD response

7. Further testing Further testing Labeling (COPD, Asthma, etc) Labeling (COPD, Asthma, etc) Medicine Medicine Disability Disability Further testing Further testing Labeling (COPD, Asthma, etc) Labeling (COPD, Asthma, etc) Medicine Medicine Disability Disability PFT results affect people!!!

8. Guidelines and Standards American Thoracic Society American Thoracic Society 1987 Revised Spirometry Standards 1987 Revised Spirometry Standards 1991 Reference Values & Interpretation 1991 Reference Values & Interpretation 1994 Revised Spirometry Standards 1994 Revised Spirometry Standards 1995 Diffusing Capacity 1995 Diffusing Capacity 1999 Guidelines for Methacholine and Exercise Challenge Testing 1999 Guidelines for Methacholine and Exercise Challenge Testing ATS/ERS 2005 Series; General Laboratory, Spirometry, Diffusing Capacity, Lung volumes, and Interpretation ATS/ERS 2005 Series; General Laboratory, Spirometry, Diffusing Capacity, Lung volumes, and Interpretation American Thoracic Society American Thoracic Society 1987 Revised Spirometry Standards 1987 Revised Spirometry Standards 1991 Reference Values & Interpretation 1991 Reference Values & Interpretation 1994 Revised Spirometry Standards 1994 Revised Spirometry Standards 1995 Diffusing Capacity 1995 Diffusing Capacity 1999 Guidelines for Methacholine and Exercise Challenge Testing 1999 Guidelines for Methacholine and Exercise Challenge Testing ATS/ERS 2005 Series; General Laboratory, Spirometry, Diffusing Capacity, Lung volumes, and Interpretation ATS/ERS 2005 Series; General Laboratory, Spirometry, Diffusing Capacity, Lung volumes, and Interpretation

9. Guidelines and Standards American Association of Respiratory Care (AARC) American Association of Respiratory Care (AARC) Clinical Practice Guidelines (52) Clinical Practice Guidelines (52) Spirometry Spirometry Static lung volumes Static lung volumes Plethysmography Plethysmography Diffusing Capacity Diffusing Capacity Infant/Toddler Pulmonary Function Tests Infant/Toddler Pulmonary Function Tests American Association of Respiratory Care (AARC) American Association of Respiratory Care (AARC) Clinical Practice Guidelines (52) Clinical Practice Guidelines (52) Spirometry Spirometry Static lung volumes Static lung volumes Plethysmography Plethysmography Diffusing Capacity Diffusing Capacity Infant/Toddler Pulmonary Function Tests Infant/Toddler Pulmonary Function Tests

10. Guidelines and Standards American Thoracic Society American Thoracic Society ATS Pulmonary Function Laboratory Management and Procedure Manual ATS Pulmonary Function Laboratory Management and Procedure Manual Updated 2005 Updated 2005 www.thoracic.org www.thoracic.org Education Education Education Products Education Products American Thoracic Society American Thoracic Society ATS Pulmonary Function Laboratory Management and Procedure Manual ATS Pulmonary Function Laboratory Management and Procedure Manual Updated 2005 Updated 2005 www.thoracic.org www.thoracic.org Education Education Education Products Education Products

11. CLSI’s Quality System In Respiratory Care – HS4-A2 Patient assessment Clinical interpretation application Path of workflow QSE Patient

12. Spirometry in Primary Care Practice * Spirometry in Primary Care Practice * 30 primary care clinics, 15 trained group /15 usual group 30 primary care clinics, 15 trained group /15 usual group 3.4% in usual group and 13.5% in trained group met ATS acceptability and reproducibility criteria 3.4% in usual group and 13.5% in trained group met ATS acceptability and reproducibility criteria 1,012 pt. tests, 2,928 blows (2.89) 1,012 pt. tests, 2,928 blows (2.89) * Eaton et al, Chest 1999; 116:416-423 * Eaton et al, Chest 1999; 116:416-423 Spirometry in Primary Care Practice * Spirometry in Primary Care Practice * 30 primary care clinics, 15 trained group /15 usual group 30 primary care clinics, 15 trained group /15 usual group 3.4% in usual group and 13.5% in trained group met ATS acceptability and reproducibility criteria 3.4% in usual group and 13.5% in trained group met ATS acceptability and reproducibility criteria 1,012 pt. tests, 2,928 blows (2.89) 1,012 pt. tests, 2,928 blows (2.89) * Eaton et al, Chest 1999; 116:416-423 * Eaton et al, Chest 1999; 116:416-423 Evidence of Quality Testing

13. Improving the Quality of Bedside Spirometry Improving the Quality of Bedside Spirometry Audit of testing outside the PF lab - Cleveland Clinic Audit of testing outside the PF lab - Cleveland Clinic 15% - ATS acceptability/reproducibility criteria 15% - ATS acceptability/reproducibility criteria CI Project - 63.5% acceptability/reproducibility CI Project - 63.5% acceptability/reproducibility Stoller JK. Orens DK. Hoisington E. McCarthy K. Bedside spirometry in a tertiary care hospital: The Cleveland Clinic experience. Respiratory Care. 47(5):578-82, 2002 May Stoller JK. Orens DK. Hoisington E. McCarthy K. Bedside spirometry in a tertiary care hospital: The Cleveland Clinic experience. Respiratory Care. 47(5):578-82, 2002 May Improving the Quality of Bedside Spirometry Improving the Quality of Bedside Spirometry Audit of testing outside the PF lab - Cleveland Clinic Audit of testing outside the PF lab - Cleveland Clinic 15% - ATS acceptability/reproducibility criteria 15% - ATS acceptability/reproducibility criteria CI Project - 63.5% acceptability/reproducibility CI Project - 63.5% acceptability/reproducibility Stoller JK. Orens DK. Hoisington E. McCarthy K. Bedside spirometry in a tertiary care hospital: The Cleveland Clinic experience. Respiratory Care. 47(5):578-82, 2002 May Stoller JK. Orens DK. Hoisington E. McCarthy K. Bedside spirometry in a tertiary care hospital: The Cleveland Clinic experience. Respiratory Care. 47(5):578-82, 2002 May

14. Evidence of Quality Testing Wanger J, Irvin C Resp Care 36 (12): 1991 Wanger J, Irvin C Resp Care 36 (12): 1991 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) DLCO CV 11.5 - 18.6 with the largest diff. 24 units DLCO CV 11.5 - 18.6 with the largest diff. 24 units Wanger J, Irvin C Resp Care 36 (12): 1991 Wanger J, Irvin C Resp Care 36 (12): 1991 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) DLCO CV 11.5 - 18.6 with the largest diff. 24 units DLCO CV 11.5 - 18.6 with the largest diff. 24 units

15. Quality Improvement Put into Practice - Quality Assurance “Systematic” approach of monitoring and evaluating quality. “Systematic” approach of monitoring and evaluating quality.

16. Quality Improvement Put into Practice - Quality Assurance CLSI’s “Path of workflow” Model CLSI’s “Path of workflow” Model Pre-test Pre-test Testing session Testing session Post-test Post-test CLSI’s “Path of workflow” Model CLSI’s “Path of workflow” Model Pre-test Pre-test Testing session Testing session Post-test Post-test

17. Quality Improvement Put into Practice Pre-test Quality Assurance Pre-test instructions Pre-test instructions Appropriate order Appropriate order Questionnaire Questionnaire Height* and weight Height* and weight Networked systems Networked systems Equipment quality assurance program Equipment quality assurance program Pre-test instructions Pre-test instructions Appropriate order Appropriate order Questionnaire Questionnaire Height* and weight Height* and weight Networked systems Networked systems Equipment quality assurance program Equipment quality assurance program

18. Quality Improvement Put into Practice Pre-test Quality Assurance Equipment quality assurance Equipment quality assurance Validation/Verification Validation/Verification Preventive maintenance Preventive maintenance Documentation and records (logbooks) Documentation and records (logbooks) Equipment quality assurance Equipment quality assurance Validation/Verification Validation/Verification Preventive maintenance Preventive maintenance Documentation and records (logbooks) Documentation and records (logbooks) Mechanical models Mechanical models Biological models Biological models

19. Quality Improvement Put into Practice Pre-test Quality Assurance Mechanical Model Mechanical Model 3-liter syringe 3-liter syringe 0.5, 1-2, 6 second flows 0.5, 1-2, 6 second flows Leak checked Leak checked Stored and used in such a way as to maintain the same temperature and humidity of the testing site Validated based on manufacturer recommendations Validated based on manufacturer recommendations Mechanical Model Mechanical Model 3-liter syringe 3-liter syringe 0.5, 1-2, 6 second flows 0.5, 1-2, 6 second flows Leak checked Leak checked Stored and used in such a way as to maintain the same temperature and humidity of the testing site Validated based on manufacturer recommendations Validated based on manufacturer recommendations 2005 ATS/ERS Standards Standardization of Spirometry

20. Quality Improvement Put into Practice Pre-test Quality Assurance Mechanical Model - Plethysmography Validation using a known volume should be performed periodically Validation using a known volume should be performed periodically Model lung with thermal mass to simulate isothermal conditions of the lung. Model lung with thermal mass to simulate isothermal conditions of the lung. Accuracy 50 ml or 3% Accuracy 50 ml or 3% Mechanical Model - Plethysmography Validation using a known volume should be performed periodically Validation using a known volume should be performed periodically Model lung with thermal mass to simulate isothermal conditions of the lung. Model lung with thermal mass to simulate isothermal conditions of the lung. Accuracy 50 ml or 3% Accuracy 50 ml or 3% 2005 ATS/ERS Standards Standardization of Lung Volumes

21. Quality Improvement Put into Practice Pre-test Quality Assurance Mechanical Model – Dilution techniques Mechanical Model – Dilution techniques Analyzer accuracy and linearity N 2 washout: Monthly, exhalation volumes should be checked with the syringe filled with room air, and inhalation volumes with the syringe filled with 100% O2. Mechanical Model – Dilution techniques Mechanical Model – Dilution techniques Analyzer accuracy and linearity N 2 washout: Monthly, exhalation volumes should be checked with the syringe filled with room air, and inhalation volumes with the syringe filled with 100% O2. 2005 ATS/ERS Standards Standardization of Lung Volumes

22. Quality Improvement Put into Practice Pre-test Quality Assurance Mechanical Models – DLCO Mechanical Models – DLCO Syringe DLCO weekly or whenever problems occur Syringe DLCO weekly or whenever problems occur V A BTPS ~ 3.3L V A BTPS ~ 3.3L DLCO Simulator or BioQC DLCO Simulator or BioQC Mechanical Models – DLCO Mechanical Models – DLCO Syringe DLCO weekly or whenever problems occur Syringe DLCO weekly or whenever problems occur V A BTPS ~ 3.3L V A BTPS ~ 3.3L DLCO Simulator or BioQC DLCO Simulator or BioQC 2005 ATS/ERS Standards Standardization of DLCO

23. Quality Improvement Put into Practice Pre-test Quality Assurance Biological Model Biological Model Normal laboratory subjects Normal laboratory subjects Two individuals (13) Two individuals (13) Establish mean and SD (minimum 20 samples) Establish mean and SD (minimum 20 samples) Biological Model Biological Model Normal laboratory subjects Normal laboratory subjects Two individuals (13) Two individuals (13) Establish mean and SD (minimum 20 samples) Establish mean and SD (minimum 20 samples)

24. Quality Improvement Put into Practice Pre-test Quality Assurance Biological Control - Plethysmography At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested Biological Control - Plethysmography At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

25. Quality Improvement Put into Practice Pre-test Quality Assurance Biological Control – N 2 washout At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested Biological Control – N 2 washout At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

26. Quality Improvement Put into Practice Pre-test Quality Assurance Biologic Control – He dilution At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested Biologic Control – He dilution At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

27. Quality Improvement Put into Practice Pre-test Quality Assurance Biologic Control – Diffusing Capacity At least weekly At least weekly Or whenever errors are suspect Or whenever errors are suspect Or whenever a calibration tank is replaced Or whenever a calibration tank is replaced Biologic Control – Diffusing Capacity At least weekly At least weekly Or whenever errors are suspect Or whenever errors are suspect Or whenever a calibration tank is replaced Or whenever a calibration tank is replaced 2005 ATS/ERS Standards - Standardization of DLCO

28. Quality Assurance Biological Quality Control - PF Lab Results “Out of range” Results “Out of range”  Repeat with another technologist  Second tech is within limits - record out of range data  Second tech out of range - trouble-shoot and document BioQC1: ULNLLNSDCV FEV 1 2.952.730.050.02 FVC3.623.350.070.02 TLC (Pleth)6.095.650.110.02 D L CO24.521.50.750.04 Results “Out of range” Results “Out of range”  Repeat with another technologist  Second tech is within limits - record out of range data  Second tech out of range - trouble-shoot and document BioQC1: ULNLLNSDCV FEV 1 2.952.730.050.02 FVC3.623.350.070.02 TLC (Pleth)6.095.650.110.02 D L CO24.521.50.750.04

29. Quality Assurance Biological Quality Control - DLCO Model A versus B: Mean difference 0.5

30. Quality Assurance Subject comparisons: DLCO Model A versus B - Mean difference 1.5

32. Quality Improvement Put into Practice Test Quality Assurance Testing room environment Testing room environment Environmental interference Environmental interference Technologist’s performance & training - QSE: Personnel Technologist’s performance & training - QSE: Personnel Second technologist Second technologist Meeting ATS/ERS acceptability and repeatability criteria (new guidelines) Meeting ATS/ERS acceptability and repeatability criteria (new guidelines) Testing room environment Testing room environment Environmental interference Environmental interference Technologist’s performance & training - QSE: Personnel Technologist’s performance & training - QSE: Personnel Second technologist Second technologist Meeting ATS/ERS acceptability and repeatability criteria (new guidelines) Meeting ATS/ERS acceptability and repeatability criteria (new guidelines)

33. Quality Improvement Put into Practice Test Quality Assurance - QSE: Personnel Technologists Technologists Job qualifications Job qualifications Job descriptions Job descriptions Orientation Orientation Training Training Competency assessment Competency assessment Continuing education Continuing education Performance appraisal Performance appraisal Technologists Technologists Job qualifications Job qualifications Job descriptions Job descriptions Orientation Orientation Training Training Competency assessment Competency assessment Continuing education Continuing education Performance appraisal Performance appraisal

34. Quality Improvement Put into Practice Test Quality Assurance - QSE: Personnel Competence Assessment Competence Assessment Training and on-going performance evaluations Training and on-going performance evaluations NIOSH Spirometry Training Course NIOSH Spirometry Training Course cdc.gov/NIOSH/topics/spirometry cdc.gov/NIOSH/topics/spirometry AARC’s Spirometry Training AARC’s Spirometry Training National Board for Respiratory Care National Board for Respiratory Care CPFT and RPFT exams CPFT and RPFT exams Competence Assessment Competence Assessment Training and on-going performance evaluations Training and on-going performance evaluations NIOSH Spirometry Training Course NIOSH Spirometry Training Course cdc.gov/NIOSH/topics/spirometry cdc.gov/NIOSH/topics/spirometry AARC’s Spirometry Training AARC’s Spirometry Training National Board for Respiratory Care National Board for Respiratory Care CPFT and RPFT exams CPFT and RPFT exams

35. Quality Improvement Put into Practice Test Quality Assurance Lung volumes - DLCO V A 500 ml larger than TLC - ??? Lung volumes - DLCO V A 500 ml larger than TLC - ??? Technologist Driven Protocols Technologist Driven Protocols Reference equations Reference equations Lung volumes - DLCO V A 500 ml larger than TLC - ??? Lung volumes - DLCO V A 500 ml larger than TLC - ??? Technologist Driven Protocols Technologist Driven Protocols Reference equations Reference equations

36. Technologist Driven Protocols Technologist Driven Protocols Flowcharting the process Flowcharting the process Technologist Driven Protocols Technologist Driven Protocols Flowcharting the process Flowcharting the process Quality Improvement Put into Practice Test Quality Assurance

37. Quality Improvement Put into Practice Post-Test Quality Assurance Maneuver selection Maneuver selection Quality review by second technologist Quality review by second technologist “While in-house training may achieve the desired goals, laboratory directors should strongly consider the benefits of formal training programs from outside providers.” Feedback to the technicians concerning their performance should be provided on a routine basis Maneuver selection Maneuver selection Quality review by second technologist Quality review by second technologist “While in-house training may achieve the desired goals, laboratory directors should strongly consider the benefits of formal training programs from outside providers.” Feedback to the technicians concerning their performance should be provided on a routine basis 2005 ATS/ERS Standards General Laboratory

38. Technician Training and Feedback Improve Test Quality Lung Health Study Enright: Am Rev Respir Dis 143:1215, 1991 4.03.5 3.0 2.5 2.0 1234567 GPA Year Quality control feedback started Site visits and training update Volume grade Flow grade

39. Quality Improvement Put into Practice Post-Test Quality Assurance Turn-around time Turn-around time Average TRT: 7 d (3%) Average TRT: 7 d (3%) ATS PFL Registry Abstract AARC 2005, OF-05-037 ATS PFL Registry Abstract AARC 2005, OF-05-037 Electronic Medical Record Electronic Medical Record Turn-around time Turn-around time Average TRT: 7 d (3%) Average TRT: 7 d (3%) ATS PFL Registry Abstract AARC 2005, OF-05-037 ATS PFL Registry Abstract AARC 2005, OF-05-037 Electronic Medical Record Electronic Medical Record

40. Quality Improvement Put into Practice Does it Work? Retrospective review of 18,000 consecutive pts. at Mayo Clinic Ninety percent of the patients were able to reproduce FEV1 within 120 ml (6.1%), FVC within 150 ml (5.3%), and PEF within 0.80 L (12%). Enright PL. Beck KC. Sherrill DL. Repeatability of spirometry in 18,000 adult patients. American Journal of Respiratory & Critical Care Medicine. 169(2):235-8, 2004 Jan 15. Retrospective review of 18,000 consecutive pts. at Mayo Clinic Ninety percent of the patients were able to reproduce FEV1 within 120 ml (6.1%), FVC within 150 ml (5.3%), and PEF within 0.80 L (12%). Enright PL. Beck KC. Sherrill DL. Repeatability of spirometry in 18,000 adult patients. American Journal of Respiratory & Critical Care Medicine. 169(2):235-8, 2004 Jan 15.

41. “This is fine as far as it goes. From here on, it’s who you know.”