Quality Improvement Put into Practice

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

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

3. Case Presentation • CXR • Spirometry & DLCO Pre Post Pred FVC 2.102.11 62% FEV1 0.89 1.36 31% Ratio 42.4 64.5 DLCO 8.0 30% Impression: Severe obstruction with a severe reduction in DLCO. Some improvement with BD

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

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

6. Case Presentation • Spirometry & DLCO Pre Post Pred FVC 2.55 2.48 75% FEV1 2.27 2.25 79% Ratio 89 90.7 DLCO 24.2 99% Impression: Borderline restriction most likely 2 to obesity with no evidence of airflow obstruction or BD response

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

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

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

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

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

12. Evidence of Quality Testing • Spirometry in Primary Care Practice* • 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 • 1,012 pt. tests, 2,928 blows (2.89) • * Eaton et al, Chest 1999; 116:416-423

13. Evidence of Quality Testing • Improving the Quality of Bedside Spirometry • Audit of testing outside the PF lab - Cleveland Clinic • 15% - ATS acceptability/reproducibility criteria • 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

14. Evidence of Quality Testing • Wanger J, Irvin C Resp Care 36 (12): 1991 • 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) • 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.

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

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

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

19. Quality Improvement Put into PracticePre-testQuality Assurance • Mechanical Model • 3-liter syringe • 0.5, 1-2, 6 second flows • 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 2005 ATS/ERS Standards Standardization of Spirometry

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

21. Quality Improvement Put into PracticePre-testQuality Assurance • Mechanical Model – Dilution techniques • Analyzer accuracy and linearity • N2 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 PracticePre-testQuality Assurance • Mechanical Models – DLCO • Syringe DLCO weekly or whenever problems occur • VA BTPS ~ 3.3L • DLCO Simulator or BioQC 2005 ATS/ERS Standards Standardization of DLCO

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

24. Quality Improvement Put into PracticePre-testQuality Assurance Biological Control - Plethysmography • 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 PracticePre-testQuality Assurance Biological Control – N2 washout • 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 PracticePre-testQuality Assurance Biologic Control – He dilution • 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 PracticePre-testQuality Assurance Biologic Control – Diffusing Capacity • At least weekly • Or whenever errors are suspect • Or whenever a calibration tank is replaced 2005 ATS/ERS Standards - Standardization of DLCO

28. Quality AssuranceBiological Quality Control - PF Lab • 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: ULN LLN SD CV FEV1 2.95 2.73 0.05 0.02 FVC 3.62 3.35 0.07 0.02 TLC (Pleth) 6.09 5.65 0.11 0.02 DLCO 24.5 21.5 0.75 0.04

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

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

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

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

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

35. Quality Improvement Put into PracticeTestQuality Assurance • Lung volumes - DLCO VA 500 ml larger than TLC - ??? • Technologist Driven Protocols • Reference equations

36. Quality Improvement Put into PracticeTestQuality Assurance • Technologist Driven Protocols • Flowcharting the process

37. Quality Improvement Put into PracticePost-TestQuality Assurance • Maneuver selection • 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. 4.0 Volume grade 3.5 Flow grade 3.0 Quality controlfeedback started 2.5 Site visits andtraining update 2.0 1 2 3 4 5 6 7 Technician Training and Feedback Improve Test Quality GPA Year Lung Health StudyEnright: Am Rev Respir Dis 143:1215, 1991

39. Quality Improvement Put into PracticePost-TestQuality Assurance • Turn-around time • Average TRT: <1 day (15%), 1-2 d (30%), 3-4 d (27%), 5-6 d (15%), >7 d (3%) • ATS PFL Registry Abstract AARC 2005, OF-05-037 • 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.

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